Deadline: 21 Oct 2026
European Union: the last 2026 window to request a joint scientific consultation closes 21 October
A joint scientific consultation lets a developer shape the comparator and endpoints a later joint assessment will ask about. It must be requested while the pivotal study is still a plan. The 2026 work programme plans two to five device consultations; the last request period runs 23 September to 21 October 2026.
What to do. If your device is likely to be selected and the study is not yet running, request a consultation before 21 October, or watch for the 2027 windows.
ImplantableActive (powered)IVDHTA & reimbursementClinical evidence & trials
Sources (2) · verified against the instrument 19 Oct 2026
Comments close: 24 Oct 2026
India: draft CDSCO guidance for IVD manufacturing licence applications
CDSCO published draft guidance for manufacturers applying for IVD manufacturing licences on its online system and NSWS, section by section against the checklist. Comments are due within 15 days of publication on 9 October 2026, so by 24 October 2026 by our count. It is an awareness document, not a rule change.
What to do. If you make IVDs in India, check your next licence application against the draft and send comments by 24 October.
IVDRegistration route
Sources (1) · verified against the instrument 20 Oct 2026
South Korea
Applied; rule pending
Comments close: 26 Oct 2026
South Korea: Class 2 technical review and certification in one application
Since 30 September 2026 an applicant can file the technical-document review and the Class 2 certification together, with a 25-day processing period. Before, the review came first from one of eight designated review bodies, then a separate certification application. The old two-step route stays open. MFDS applied the change administratively; the rule amendment is in consultation until 26 October and takes effect on 10 December 2026.
What to do. Ask your Korean licence holder which route your next Class 2 filing will take. Treat 25 days as the authority's processing period, not your time to first sale.
All devicesRegistration route
Sources (1) · verified against the instrument 14 Oct 2026
Deadline: 31 Oct 2026
United Kingdom: applications to the MHRA's AI Airlock sandbox are open; apply by 31 October for the current wave
Phase 3 of the MHRA's regulatory sandbox for AI-enabled medical devices opened on 6 October 2026. Organisations of any size may apply, prototypes included, with priority for proposals on post-market surveillance and lifecycle oversight. There is no fee, but participants fund their own studies and testing, typically 6 to 12 months. The window stays open all year: applications made before 31 October join the current review wave, later ones the next, with shortlisting in spring 2027. The phase is funded to April 2029.
What to do. If your AI device raises a regulatory question you would rather test with the MHRA than guess at, apply by 31 October.
Software & AISoftware & AI rules
Sources (1) · verified against the instrument 19 Oct 2026
Australia
Final — not yet in force
Starts: 1 Nov 2026
Australia: the exemption for clinical decision support software narrows on 1 November 2026
From 1 November 2026 decision support software stays exempt from ARTG inclusion only if it does not analyse an image or signal from another device, does not make the diagnosis or treatment decision itself, and shows the clinician the guidelines, calculations or logic behind each recommendation. The change also applies to software made before 1 November and used after it.
What to do. Before 1 November, test each exempt product against the new conditions, especially showing its logic. A product that fails needs an ARTG inclusion plan or different claims.
Software & AISoftware & AI rulesRegistration route
Sources (1) · verified against the instrument 19 Oct 2026
China
Final — not yet in force
Deadline: 1 Nov 2026
China: the revised device GMP applies from 1 November 2026
NMPA Announcement 2025 No. 107 (4 November 2025) issues a revised device GMP of 132 articles, replacing the 2014 version on 1 November 2026. It applies to registrants, filers and contract manufacturers, and brings outsourced design, contract manufacturing, outsourced processing and outsourced testing inside the quality system. Where manufacturing is contracted out, the contract manufacturer does production release and the registrant does release to market.
What to do. Check that quality agreements with contract manufacturers and test labs cover the controls the new GMP expects before 1 November.
All devicesQMS & GMP
Sources (1) · verified against the instrument 20 Oct 2026
Comments close: 1 Nov 2026
Egypt: EDA consults on the fourth edition of its guide to changing a notified imported-device registration
EDA's Central Administration for Medical Devices opened a 10-working-day stakeholder survey on Monday 19 October 2026 on the fourth edition of its guide to amending the data in a registration notification for an imported device holding international quality certificates. Comments go on EDA's feedback form to md.variation@edaegypt.gov.eg. By our count, on Egypt's Sunday-to-Thursday working week, the window closes on 1 November 2026. We have not compared the draft with the third edition.
What to do. If you plan design, labelling, site or software changes to an Egyptian registration, have your local holder review the draft and comment by 1 November.
All devicesSoftware & AIPost-market & vigilance
Sources (1) · verified against the instrument 20 Oct 2026
United States
Open for comment
Comments close: 17 Nov 2026
United States: draft guidance would move PMAs onto the eSTAR electronic template
A draft guidance announced on 18 September 2026 introduces the electronic submission template for original PMAs, panel-track, 180-day and real-time supplements, and 30-day notices and 135-day supplements. When final, it will set the timetable from which these submissions must be filed electronically in that format, as FDA already requires for De Novo requests. Comments are due by 17 November 2026.
What to do. If a PMA or PMA supplement is planned for 2027, comment on the timetable by 17 November and start building the dossier in the template.
All devicesRegistration routeAdministrative
Sources (1) · verified against the instrument 20 Oct 2026
United States
Open for comment
Comments close: 24 Nov 2026
United States: FDA draft guidance on premarket submissions for robotically-assisted surgical devices
FDA published draft recommendations for premarket submissions for robotically-assisted surgical devices. It is a draft, not for implementation. Comments are due by 24 November 2026.
What to do. If you develop a surgical robot, read the draft against your planned submission and comment by 24 November.
Active (powered)Registration route
Sources (1) · verified against the instrument 19 Oct 2026
Deadline: 27 Nov 2026
European Union: EUDAMED is mandatory, and devices already on the market must be registered by 27 November 2026
Commission Decision (EU) 2025/2371, published on 27 November 2025, declared four EUDAMED modules functional: actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. Under Regulation (EU) 2024/1860 they became mandatory 6 months later, on 28 May 2026. Devices still being placed on the market after that date, including legacy devices under the MDR transitional provisions, must be in the UDI/device module within 12 months of the notice, which by our count is 27 November 2026. The vigilance and clinical-investigation modules are not yet mandatory.
What to do. Count the Basic UDI-DIs you still place on the EU market and finish the device registrations before 27 November 2026; non-EU makers need actor registration through their authorised representative first.
All devicesAdministrativeLabelling
Sources (2) · verified against the instrument 20 Oct 2026
Canada
Final — not yet in force
Starts: 1 Dec 2026
Canada: establishment-licence holders must name their suppliers from December 2026
SOR/2026-110 requires applicants for a medical device establishment licence to give the name and address of each supplier that is not a manufacturer and the device classes it supplies, and to update the list at the annual review. Importers no longer have to buy from foreign distributors that hold a licence. The regulation takes effect on the 180th day after its registration on 4 June 2026, which by our count is 1 December 2026; Health Canada's bulletin gives 14 December. A pending application cannot be granted unless the supplier information was filed by that day.
What to do. If you sell through a distributor into Canada, expect your importer to name it to Health Canada, and plan for 1 December, the earlier of the two dates.
All devicesImport & licensing
Sources (2) · verified against the instrument 19 Oct 2026
Deadline: 31 Dec 2026
Switzerland: devices must be registered in swissdamed, with a transition to 31 December 2026
Since 1 July 2026, manufacturers and their Swiss authorised representatives must register devices, systems and procedure packs placed on the Swiss market in the swissdamed UDI Devices module. The transition period runs to 31 December 2026, but devices with a serious incident, field safety corrective action or trend report must be registered at once. Registration replaces the old notification for Class I devices and IVDs. Swissmedic will charge CHF 200 for the first UDI-DI and CHF 20 for each further UDI-DI on the market, capped at CHF 10,000 a year, invoiced from January 2027.
What to do. Have your CH-REP register every device before 31 December 2026 and budget the per-UDI-DI fee.
All devicesAdministrativeFees
Sources (2) · verified against the instrument 20 Oct 2026
Deadline: 31 Dec 2026
Singapore: HSA waives evaluation fees to move clinically needed devices off special access
HSA will waive evaluation fees for eligible devices now supplied through the Special Access Route, so they can be formally registered. It is aimed at devices for small patient populations with limited commercial viability in Singapore. A clinician starts the process with a Clinical Justification and Endorsement Form and the supplier files. The first window closes 31 December 2026; after that it opens every year from 1 October to 31 December.
What to do. If your device reaches Singapore patients through special access, ask the clinicians who use it to endorse it before 31 December.
All devicesFeesRegistration route
Sources (1) · verified against the instrument 20 Oct 2026
Deadline: 31 Dec 2026
Israel: the pilot accepting MDR certificates from notified bodies in non-recognised countries runs to 31 December 2026
The Health Ministry's medical device division (AMAR) extended its pilot that accepts, for registration in the Israeli medical device register, EU MDR CE certificates issued by notified bodies that the EU designated under the MDR but that sit in countries Israel's Medical Equipment Law does not recognise. The pilot now runs to 31 December 2026, after which the ministry will review its policy in light of the results.
What to do. If your CE certificate comes from such a notified body, file in Israel before 31 December 2026, or plan for the policy to change after that date.
All devicesReliance & recognition
Sources (1) · verified against the instrument 20 Oct 2026
Canada
Final — not yet in force
Starts: 1 Feb 2027
Canada: new forms for the medical-device Special Access Program, mandatory from 1 February 2027
Health Canada's notice of 24 August 2026 introduces a new application form, a spreadsheet template and a secure transmission tool for the Special Access Program for devices. From 1 February 2027 it will accept only applications made this way.
What to do. Replace the old forms and links in any clinician-facing material before 1 February 2027.
All devicesRegistration routeAdministrative
Sources (1) · verified against the instrument 19 Oct 2026
Comments close: 17 Mar 2027
Japan: PMDA draft review points for generative-AI medical devices
PMDA published draft review points (dated 14 September 2026; English translation 14 October) for devices built on large language or vision-language models: a total life-cycle approach, a narrow intended use first, post-market reporting of hallucinations and adverse events, and monitoring of agent-like functions. Not binding. Comments are open until 17 March 2027.
What to do. If you build a generative-AI device, read the draft, plan Japanese-language evaluation, and comment by 17 March 2027.
Software & AISoftware & AI rules
Sources (2) · verified against the instrument 19 Oct 2026
United Kingdom
Comment period closed
Starts: 1 Apr 2027
Great Britain: MHRA proposes raising the annual device fee from £300 to £511 per category from April 2027
The MHRA consulted from 17 August to 25 September 2026 on fees from 1 April 2027. For devices it proposes £511 instead of £300 per chargeable GMDN Level 2 category, still part-subsidised for 2027/28 and 2028/29, a device regulatory advice meeting at £2,245 instead of £987, most other fees up 8.93%, and fee waivers for eligible UK-based SMEs. No government response has been published yet.
What to do. Budget £511 per chargeable category for 2027/28 until the government response confirms the figure.
All devicesFees
Sources (2) · verified against the instrument 20 Oct 2026
Deadline: 4 May 2027
Indonesia: a new health-supplies regulation replaces the 2017 device registration rule
Permenkes 5/2026 on health supplies (promulgated 4 May 2026, in force that day) revokes Permenkes 62/2017 on device marketing authorisation, along with the 2014 special-access, 2017 import-supervision and other device regulations. Existing implementing rules stay in force where they do not conflict, and the sector has one year to adjust, to 4 May 2027 by our count. Marketing-authorisation holders must report a potential shortage at least six months ahead. The regulation also allows faster authorisation for innovative products used in other countries, but leaves the details to a ministerial guideline not yet issued.
What to do. Ask your Indonesian licence holder whether your next filing or renewal follows any new requirement, and set up the six-month shortage notice.
All devicesIVDRegistration routeImport & licensingSupply & shortages
Sources (1) · verified against the instrument 20 Oct 2026
Mexico
Final — not yet in force
Starts: 14 May 2027
Mexico: a new device labelling standard, with a visible version identifier for software
NOM-137-SSA1-2025 (published 19 May 2026) replaces the 2008 labelling standard and takes effect 360 calendar days after publication, 14 May 2027 by our count. Software as a medical device must carry an identifier (version, revision or release date) the user can see; software with no physical form may be labelled electronically; labels must be in Spanish and match the registration.
What to do. Schedule the new standard into your next label revision; for software, show the version in the product and link to the labelling from inside it.
All devicesSoftware & AILabellingSoftware & AI rules
Sources (1) · verified against the instrument 19 Oct 2026
Deadline: 1 Jun 2027
South Africa: ISO 13485 certification becomes a condition of device establishment licences, in phases to 2028
SAHPRA requires manufacturers and distributors (importers) holding a medical device establishment licence to hold ISO 13485 certification from a conformity assessment body SAHPRA recognises, in the name and at the address of the South African establishment. It applies to licence renewals from 1 June 2025, to holders already certified (who are asked to submit the certificate) from 1 April 2026, to licence amendments and product-list notifications from 1 June 2027, and to all new licence applications from 1 April 2028. Product registration of devices has still not been called up, so the establishment licence remains the main control.
What to do. Check that your South African importer holds, or is working towards, ISO 13485 from a SAHPRA-recognised body; an importer that cannot renew its licence cannot import your product.
All devicesIVDQMS & GMPImport & licensing
Sources (3) · verified against the instrument 20 Oct 2026
Canada
Final — not yet in force
Starts: 17 Jun 2027
Canada: amended device shortage and discontinuation reporting starts 17 June 2027
Guide GUI-0137 v4 (7 October 2026) explains the amended shortage and discontinuation reporting duties in SOR/2026-96, which start on 17 June 2027, the first anniversary of the regulation's publication.
What to do. If you sell device categories that are subject to reporting in Canada, update your shortage-reporting procedure before June 2027.
All devicesSupply & shortagesPost-market & vigilance
Sources (1) · verified against the instrument 19 Oct 2026
Deadline: 1 Jul 2027
Australia: UDI labelling and database entry phase in from 1 July 2026
Regulations in force from 25 March 2025 require a UDI and an entry in the Australian UDI Database within 30 days of first supply on or after a device's start day. The first start day was 1 July 2026, for Class III and IIb devices not covered by an EU Directive certificate on 30 June 2026 (stock made and labelled before then has until 1 July 2029). Class IIa follows on 1 July 2027, and Class 4 IVDs and sterile Class I on 1 July 2028; devices with a Directive certificate in force get later dates.
What to do. Work out the start day for each ARTG entry and have the UDI data ready before it.
All devicesIVDLabellingPost-market & vigilance
Sources (1) · verified against the instrument 20 Oct 2026
Deadline: 1 Oct 2027
Malaysia: product classification letters now expire after five years
From 1 October 2026 new MDA product classification letters are valid for five years. Two-year letters are extended to three. Letters more than five years old must be renewed by 1 October 2027, and only if nothing has changed; otherwise a new application is needed.
What to do. List your MDA classification letters by issue date and renew any older than five years before 1 October 2027.
All devicesClassification
Sources (1) · verified against the instrument 19 Oct 2026
Chile
Final — not yet in force
Starts: 19 Mar 2028
Chile: Decree 25 makes registration mandatory for 39 device and IVD categories
Exempt Decree 25 (signed 6 March, published 19 March 2026) brings 39 listed device, IVD and software categories under ISP conformity verification, which takes the form of a sanitary registration assessed against the ISO 16142 essential principles. The obligation starts 24 months after publication for items 6 to 18 (mostly Class IV implants, plus insulin pumps and blood bags) and 36 months for the rest: by our count 19 March 2028 and 19 March 2029. Voluntary early registration opens once ISP issues its technical instruction, due within 12 months of publication. After registration, a significant change needs a new registration.
What to do. Check whether your products are on the list, and plan registration so it is granted before your category's deadline.
ImplantableActive (powered)Non-activeIVDSoftware & AIRegistration routeClassification
Sources (1) · verified against the instrument 20 Oct 2026
European Union
Final — not yet in force
Starts: 2 Aug 2028
European Union: AI Act high-risk obligations for AI medical devices move to 2 August 2028
Regulation (EU) 2026/1744 (8 July 2026) moves the AI Act's high-risk obligations to 2 August 2028 for AI systems that are high-risk because they sit in a product under Annex I, which includes medical devices and IVDs. Systems listed in Annex III move to 2 December 2027.
What to do. Certify under the MDR or IVDR now, and run an AI Act gap analysis during 2027.
Software & AIIVDSoftware & AI rules
Sources (1) · verified against the instrument 19 Oct 2026
Published: 20 Oct 2026
European Union: the Commission's proposal to simplify the MDR and IVDR is still in Parliament committee
COM(2025) 1023 (16 December 2025) would remove the 5-year limit on certificates in favour of risk-based periodic reviews, allow surveillance audits every two years where there are no safety issues and make unannounced audits for-cause, cut notified-body review of Class IIa/IIb and B/C devices to representative devices, take sterile Class A IVDs out of notified-body review, limit the summary of safety and (clinical) performance to devices whose technical documentation the notified body assesses, give 30 days instead of 15 for some serious-incident reports, and add priority review for breakthrough and orphan devices and notified-body fee cuts for micro and small makers. None of this is law. The Parliament committee (SANT) has a draft report (30 June 2026) but has not voted; the indicative plenary date is 14 December 2026.
What to do. Keep planning to the MDR and IVDR as they stand; budget certification and surveillance on today's rules, not the proposal.
All devicesRegistration routePost-market & vigilanceFees
Sources (2) · verified against the instrument 20 Oct 2026
Published: 20 Oct 2026
European Union: guidance on breakthrough devices, with designation by the expert panels
MDCG 2025-9 (December 2025) sets the criteria for a breakthrough device: a high degree of novelty and a significant positive clinical impact for a life-threatening or irreversibly debilitating condition, either better than the alternatives or meeting an unmet need. The manufacturer asks the expert panels for an opinion on breakthrough status at any stage of development; the panels aim to answer within 60 days. A designated device can get early advice from the expert panels and priority and structured dialogue with its notified body; the guidance is not binding, and the Commission said a pilot was expected in Q2 2026.
What to do. If your device is genuinely novel and addresses a serious condition, prepare the breakthrough-status application early; it is the closest EU equivalent to an early-engagement route.
All devicesRegistration routeClinical evidence & trials
Sources (2) · verified against the instrument 20 Oct 2026
Deadline passed: 16 Oct 2026
United States: FDA proposes moving breast tomosynthesis and cystoscopic bladder-cancer detection systems to Class II
Two proposed orders would move Class III device types into Class II with special controls, subject to 510(k): digital breast tomosynthesis systems (product code OTE; proposed 10 August 2026, comments closed 9 October 2026) and diagnostic endoscopic light source systems, to be renamed cystoscopic systems intended as an aid for detection of bladder cancer (product code OAY; proposed 17 August 2026, comments closed 16 October 2026). Neither order is final, so PMA still applies until a final order takes effect.
What to do. If you are developing either device type, wait for the final order before choosing between a PMA and a 510(k).
Active (powered)ClassificationRegistration route
Sources (2) · verified against the instrument 20 Oct 2026
Deadline passed: 16 Oct 2026
United States: FDA proposes classifying certain accessories on their own in Class I, exempt from 510(k)
A notification of 17 August 2026 lists accessories, each already cleared or approved as part of another device, that FDA proposes to classify in Class I separately from the parent device and exempt from 510(k). The list covers cardiovascular, gastroenterology-urology and general surgery accessories, such as the tubing that connects a blood-pressure cuff to its monitor and mounting brackets in an ECMO circuit. Comments closed on 16 October 2026; nothing changes until FDA publishes the final list.
What to do. If you make an accessory of a listed type, compare your product with the proposed identification before planning a separate 510(k).
Active (powered)Non-activeClassificationRegistration route
Sources (1) · verified against the instrument 20 Oct 2026
Kenya
Not a device change
Published: 9 Oct 2026
Kenya: the new GMP reliance guideline covers medicines, not devices
The Pharmacy and Poisons Board's guideline on relying on other authorities' GMP decisions (posted 9 October 2026) applies to manufacturing sites for finished pharmaceutical products, active ingredients and contract research organisations. Kenya's device reliance routes are separate and unchanged.
What to do. No change for device makers; plan on Kenya's January 2025 device reliance routes.
All devicesReliance & recognitionQMS & GMP
Sources (1) · verified against the instrument 19 Oct 2026
In force: 7 Oct 2026
Argentina: GMP certificates for foreign device plants on the strength of an accredited ISO 13485 certificate
ANMAT Disposición 6403/2026 (in force 7 October) sets out how a GMP certificate is issued for a foreign device or IVD plant outside the Mercosur inspection regime: the importer files a current ISO 13485 certificate from a body accredited by an ILAC or IAF member, and ANMAT has 40 business days to evaluate, ask for more, or verify virtually or on site based on risk. One certificate per application.
What to do. Check your ISO 13485 certificate is from an accredited body and covers every plant and category you will file; plants on separate certificates need separate applications.
All devicesIVDQMS & GMPReliance & recognition
Sources (1) · verified against the instrument 19 Oct 2026
In force: 6 Oct 2026
United States: the 510(k) exemption for workplace drug tests now covers federal testing programmes
A final order covers 14 drug-of-abuse test types (21 CFR 862.3100–862.3910). Tests labelled solely for employment and insurance testing are now 510(k)-exempt even when used in federal programmes such as SAMHSA, DOT or the military, within the limits of 21 CFR 862.9. Fentanyl tests fall under the opiate regulation (product code DJG moves to PVH). Clinical and point-of-care drug tests are not affected.
What to do. If you sell a drug screen for employment or insurance testing, check that your labelling carries the required statement; a new product within those limits no longer needs a 510(k).
IVDRegistration route
Sources (1) · verified against the instrument 19 Oct 2026
Published: 6 Oct 2026
Great Britain: government accepts all 44 recommendations on regulating AI in healthcare
The government response (6 October 2026) commits to draft guidance on predetermined change control plans by December 2026 and a consultation on how software and AI are qualified and classified by spring 2027, followed by secondary legislation. No law has changed yet.
What to do. Diary December 2026 for the draft change-control guidance and plan to comment on it.
Software & AISoftware & AI rules
Sources (1) · verified against the instrument 19 Oct 2026
ThailandMalaysia
In force
In force: 6 Oct 2026
Thailand puts Malaysia's MDA on its legal list of recognised foreign agencies
A Thai FDA notification signed 6 October 2026 adds Malaysia's Medical Device Authority as item 8 of the list of foreign agencies whose device approvals Thailand accepts. It covers devices approved by MDA under the MDA–Thai FDA reliance programme, not approvals granted without MDA's safety and performance evaluation. Intended use, labelling, instructions and packaging must be identical to the Malaysian approval. Unlike the US, EU, Canadian, Australian and Japanese approvals on the same list, which must have been held for at least a year, HSA and MDA approvals carry no holding period.
What to do. If Malaysia is filed or planned, keep the Malaysian labelling and instructions identical to what you will file in Thailand, and ask your Thai licence holder to cite the notification.
All devicesReliance & recognition
Sources (1) · verified against the instrument 19 Oct 2026
In force: 2 Oct 2026
European Union: the first medical devices picked for joint clinical assessment
Implementing Decision C(2026) 7113 (2 October 2026) picks two transcatheter mitral valve systems, SAPIEN M3 (Edwards) and HighLife (HighLife SAS), for the first device assessments under the HTA Regulation. Only devices that receive an MDR expert-panel opinion can be selected: Class III implants, Class IIb devices that administer or remove medicines, and Class D IVDs. A joint assessment sets no price; member states must give it due consideration. The dossier is due within 100 days.
What to do. If your device will go through the MDR expert-panel consultation, plan the joint-assessment dossier alongside the clinical evaluation, not after it.
ImplantableActive (powered)IVDHTA & reimbursementClinical evidence & trials
Sources (2) · verified against the instrument 19 Oct 2026
In force: 1 Oct 2026
Taiwan: device trials move onto one online platform, with new rules on recruitment
From 1 October 2026 sponsors must register device-trial data on mdctp.fda.gov.tw within 30 days of approval or an approved amendment, and update it every June and December. From 5 October the revised application instructions route every filing (new applications, amendments, progress and final reports) through the same platform. Since 21 September, TFDA's recruitment notes say adverts need ethics-committee approval and may not name the investigational device or the company, claim safety or superiority, or promise free product. Approval rules are unchanged.
What to do. Check every running Taiwanese trial is on the platform before the December update, and have recruitment copy re-checked before it goes to the ethics committee.
All devicesClinical evidence & trials
Sources (3) · verified against the instrument 19 Oct 2026
In force: 1 Oct 2026
Chile: ISP publishes the scope table for mandatory device registration under Decree 25
ISP's first information note (1 October 2026) lists the 39 categories Decree 25/2026 brings under mandatory registration, with risk class, what is and is not covered, and the deadline for each: 24 months for categories 6–18 (mostly Class IV implants) and 36 months for the rest. Two software categories are included. Voluntary early registration opens only when ISP's technical instruction is published.
What to do. Check your portfolio against ISP's include and exclude columns, and watch for the technical instruction.
ImplantableActive (powered)Non-activeIVDSoftware & AIRegistration routeClassification
Sources (1) · verified against the instrument 19 Oct 2026
In force: 1 Oct 2026
Singapore: new declaration and ISO 13485 certificate rules for every registration route
From GN-15 Revision 14 (14 September 2026) every Class B, C and D application, on every route, needs a declaration on device labelling, adverse events and field safety corrective actions (Annex 4). Revision 15 (1 October 2026) adds a premarket submission checklist and requires ISO 13485 certificates to come from a certification body accredited by a Global ACI-recognised accreditation body, or from an EU MDR/IVDR notified body.
What to do. Check that your ISO 13485 certificate's issuer meets the new rule before you file, and add the Annex 4 declaration to every new application.
All devicesIVDRegistration routeQMS & GMP
Sources (1) · verified against the instrument 20 Oct 2026
In force: 1 Oct 2026
Taiwan: registration filings move online, with no paper copies of approved labels
From 1 October 2026, as a trial, filings through TFDA's electronic submission system for Class 1, 2 and 3 registration, licence changes and renewals are made as colour scans. The paper originals are kept by the licence holder rather than posted. TFDA no longer issues paper copies of approved labels, IFUs or packaging for Class 2 and 3 approvals; the approved version is published in its licence database. Fees for electronic filings are paid only through that system.
What to do. Give your licence holder clean colour scans, and keep your own controlled copy of each approved label.
All devicesAdministrativeLabelling
Sources (1) · verified against the instrument 20 Oct 2026
In force: 1 Oct 2026
United States: FY2027 device user fees apply from 1 October 2026
FDA's fee notice for fiscal year 2027 sets the 510(k) fee at $28,653 ($7,163 for a qualifying small business), De Novo at $191,020 ($47,755) and an original PMA at $636,732 ($159,183). The annual establishment registration fee is $13,785, with no small-business reduction. The rates apply from 1 October 2026 to 30 September 2027. A business with gross receipts of $100 million or less, affiliates included, can qualify for the small-business rates, and one at $30 million or less can have the fee for its first premarket application waived.
What to do. Get small-business status confirmed before you file, and budget the establishment fee even if your US sales are small.
All devicesFees
Sources (1) · verified against the instrument 20 Oct 2026
In force: 30 Sep 2026
Vietnam: more appraisal bodies for registration dossiers, paid directly by the applicant
Decision 3046/QĐ-BYT (30 September 2026) replaces the January 2024 list of bodies that appraise device dossiers on the standard registration route (used by devices without a reference-country approval). IVD appraisers widen from one to three; applicants now pay the appraising body directly at its own published price. The 10-working-day fast track for devices with a reference-country approval is unchanged.
What to do. If you file in Vietnam without a reference approval, ask your registration holder which body will appraise the dossier and at what price, and budget it separately from the state fee.
All devicesIVDRegistration routeFees
Sources (1) · verified against the instrument 19 Oct 2026
United Kingdom
Not a device change
Published: 30 Sep 2026
United Kingdom: the 14-day Phase 1 trial assessment excludes trials involving devices
The MHRA's stepwise programme cutting first review of qualifying Phase 1 medicines trials to 14 days by 28 December 2026 excludes trials that involve a medical device, an IVD or a companion diagnostic.
What to do. Plan device and combination studies on the standard MHRA routes.
All devicesClinical evidence & trials
Sources (1) · verified against the instrument 19 Oct 2026
SingaporeSaudi ArabiaMalaysia
Not a device change
Published: 17 Sep 2026
Singapore: HSA's new partnerships do not create a device route
HSA's 17 September 2026 release describes MoUs with the Saudi FDA and the African Medicines Agency and a Malaysian pilot that references HSA's assessments of medicines. None creates a submission route, fee or procedure for a medical device; devices appear only through international harmonisation work.
What to do. Do not plan a Saudi, Malaysian or African device filing around an HSA approval on the strength of this release.
All devicesReliance & recognition
Sources (1) · verified against the instrument 19 Oct 2026
United States
Not a device change
Published: 17 Sep 2026
United States: radiology CAD and triage software still needs a 510(k)
A final order published on 17 September 2026 carries the title 'Exemption From Premarket Notification', but it records a denial. A petition had asked FDA to exempt four radiology software types (21 CFR 892.2060, 892.2070, 892.2080 and 892.2090: computer-aided detection, diagnosis, and triage and notification) from 510(k) for companies that already held a clearance under the same regulations. FDA denied the petition on 1 April 2026 and the order confirms that a 510(k) is still required.
What to do. Plan a 510(k) for each new radiology CAD or triage product, even if you already hold a clearance of the same type.
Software & AISoftware & AI rulesRegistration route
Sources (1) · verified against the instrument 20 Oct 2026
Published: 16 Sep 2026
Hong Kong: a bill to regulate medical devices promised 'within the year'
The 2026 Policy Address (16 September) says the government will set up the Centre for Medical Products Regulation and submit a legislative proposal on regulating medical devices within the year. The 2025 Policy Address made the same promise. No bill has been published, and the voluntary listing system remains.
What to do. No action yet. Keep listings current and watch for the bill.
All devicesRegistration route
Sources (1) · verified against the instrument 19 Oct 2026
Published: 16 Sep 2026
Russia: new administrative rules for national device registration, with a 10-day clock for AI software changes
Roszdravnadzor Order 750 (published 16 September 2026) replaces the 2019 rules for national registration. Maximum service times run from 31 working days without human trials to 50 with them, and 10 working days for changes to the dossier of AI software. The result is an entry in the state register; no certificate is issued.
What to do. For Russian national files, plan to the new maximum times. They are statutory limits, not observed times.
All devicesSoftware & AIRegistration routeSoftware & AI rules
Sources (1) · verified against the instrument 19 Oct 2026
In force: 16 Sep 2026
United States: in situ hybridization tests tied to an approved cancer therapy move from Class III to Class II
A final order of 17 August 2026, effective 16 September 2026, reclassifies ISH test systems indicated for use with an approved oncology therapeutic (product codes NYQ, MVD, OWE and PNK) from Class III into Class II with special controls, so a new test needs a 510(k) rather than a PMA. Tests already approved by PMA can stay on the market under that approval; a significant change to one after the effective date goes through a 510(k).
What to do. If you are developing an ISH companion test, plan a 510(k) against the new special controls rather than a PMA.
IVDClassificationRegistration route
Sources (1) · verified against the instrument 20 Oct 2026
In force: 11 Sep 2026
United States: a new Class II device type for cardiovascular machine-learning notification software
A final order adds 21 CFR 870.2380, with special controls, for machine-learning software that suggests the likelihood of a single cardiovascular condition so the patient can be referred. It does not cover arrhythmia detection or diagnostic-quality output.
What to do. If you build referral software of this kind, use the special controls as your evidence plan, including for filings outside the US.
Software & AISoftware & AI rulesClassification
Sources (1) · verified against the instrument 19 Oct 2026
In force: 11 Sep 2026
Vietnam: an apostille replaces consular legalisation for documents from Convention countries
Decree 293/2026/ND-CP (23 July 2026, in force 11 September 2026) implements the Apostille Convention. A public document from a Convention member now needs an apostille instead of consular legalisation, and a certified Vietnamese translation. The decree is general, not device-specific, and excludes administrative documents directly related to commercial or customs operations.
What to do. Ask your Vietnamese registration holder whether the device desk accepts apostilled free-sale certificates and authorisation letters before you skip legalisation.
All devicesImport & licensingAdministrative
Sources (1) · verified against the instrument 20 Oct 2026
In force: 9 Sep 2026
European Union: IVD classification guidance clarifies that standalone quality-control materials stay Class B
MDCG 2020-16 rev.5 (September 2026) changes only Rule 7: it clarifies the rationale and revises the examples. A manufacturer of standalone quality-control material may state the presence or concentration range of the analyte; those indicated values are not 'assigned values', so unless another rule applies the control is Class B. Controls with values assigned by the manufacturer, including assay-kit validity controls, are classified under implementing rule 1.6.
What to do. If you make third-party QC material, check that your instructions for use limit its purpose to monitoring the laboratory's examination procedure and that your stated ranges read as indicative, not assigned.
IVDClassification
Sources (1) · verified against the instrument 20 Oct 2026
In force: 9 Sep 2026
Saudi Arabia: a reliance route for marketing authorisation on an Australian, Canadian, EU, Japanese, UK or US approval
SFDA guidance MDS-G30 (version 1.0, 9 September 2026) lets an applicant for a Saudi marketing authorisation (MDMA) cite an approval from Australia, Canada, the EU/EEA, Japan, the UK or the US for an identical device. It brings reduced documentation and a 35–60 working-day review in every class. Approvals granted 'primarily by demonstrating substantial equivalence to a predicate device' and self-declared approvals are excluded; our reading is that a US 510(k) or a self-certified EU Class I does not qualify on its own, while a PMA or De Novo does. SaMD and AI-enabled devices may be excluded at SFDA's discretion, and SFDA accepts MDSAP certificates and audit reports as quality-system evidence.
What to do. If you hold a PMA, De Novo, notified-body CE, UK, Canadian, Australian or Japanese approval for the identical device, file through the reliance route with the Reliance Form; if your only approval is a 510(k), plan the standard route or put the question to SFDA in writing first.
All devicesIVDReliance & recognitionQMS & GMP
Sources (1) · verified against the instrument 20 Oct 2026
In force: 8 Sep 2026
Australia: saline flush syringes and locking solutions are now Class IIa
A new classification rule makes non-invasive devices that contain only saline and flush or keep open another device Class IIa (Class III with an ancillary medicine), for new applications from 8 September 2026. Existing entries have five years to transition.
What to do. Make new applications under the new rule; plan transition of existing entries.
Non-activeClassification
Sources (1) · verified against the instrument 19 Oct 2026
In force: 8 Sep 2026
Hong Kong: e-signed certificates accepted for device listing, and longer supply-record retention
MDACS guidance GN-01 (revised 1 and 8 September 2026) accepts an electronic certificate when its signature can be verified on the issuer's official website, lets the Medical Device Division ask for a certified copy or check a document with the issuer, and requires the Local Responsible Person to keep supply records for the device's projected service life or seven years, whichever is longer.
What to do. Submit e-signed CE or FDA certificates as they are where the issuer offers online verification, and check your record retention.
All devicesRegistration routePost-market & vigilance
Sources (1) · verified against the instrument 19 Oct 2026
In force: 7 Sep 2026
Indonesia: imported AI for diagnosis or screening needs local clinical validation
Ministerial Decree KMK 951/2026 (in force 7 September 2026) sets out marketing authorisation for software devices. Imported moderate- or high-risk AI used for diagnosis, screening or clinical decisions needs local clinical validation, which can run in parallel with the application, with results due within a year of the grant. A regulatory sandbox is available.
What to do. Budget a validation study at an Indonesian hospital, university or accredited laboratory for any imported diagnostic or triage AI. The one-year clock starts at the grant.
Software & AISoftware & AI rulesClinical evidence & trials
Sources (1) · verified against the instrument 19 Oct 2026
In force: 7 Sep 2026
Colombia: a new supply-alert system, with device stock reporting limited to a priority list still to come
Resolution 1763 of 2026 (in effect from its publication on 7 September) creates SISCAATS. For devices, the monthly availability report covers only devices the Ministry puts on a priority list, which it has not yet published. The Ministry has six months from publication to switch availability reporting on, and each report becomes mandatory two months after it is. Incident reports (events that disrupt supply) start sooner.
What to do. Agree now who in your Colombian distribution files SISCAATS reports, and watch for the device priority list.
All devicesSupply & shortages
Sources (1) · verified against the instrument 19 Oct 2026
In force: 2 Sep 2026
Canada: shortage imports of foreign-authorised devices now need 3 business days' notice
Health Canada's updated forms (2 September 2026) cut the notice before a shipment arrives from 5 to 3 business days and ask for more evidence. Guide GUI-0147 v2 (7 October) revises the criteria for adding a device to the exceptional importation list. Both implement SOR/2026-96.
What to do. If you supply Canada through the exceptional importation list, brief your importer on the shorter notice and the new evidence fields.
All devicesSupply & shortagesImport & licensing
Sources (2) · verified against the instrument 19 Oct 2026
MexicoBrazil
Not a device change
Published: 2 Sep 2026
Mexico: the September agreement recognising Brazil's ANVISA covers medicines, not devices
The 2 September 2026 Acuerdo recognising ANVISA for an abbreviated route applies to medicine registrations only; the word 'dispositivo' does not appear. For devices, Mexico's July 2025 abbreviated route already recognises IMDRF Management Committee members, Brazil included.
What to do. Use the 2025 abbreviated device route; settle the local registration holder first.
All devicesReliance & recognition
Sources (1) · verified against the instrument 19 Oct 2026
Published: 1 Sep 2026
United Kingdom: Health Bill amendments would give the MHRA powers to build a device licensing regime
The government tabled three amendments to the Health Bill (announced 1 September 2026). They would widen the MHRA's information-sharing powers, let device and medicines legislation automatically pick up updated standards and guidelines, and amend the Medicines and Medical Devices Act 2021 to enable a future licensing regime under which devices placed on the Great Britain market through a domestic route could need an MHRA licence instead of a third-party conformity assessment. Nothing changes immediately; any regime would need consultation and further legislation.
What to do. No action now; watch the Bill's progress and any consultation on device licensing.
All devicesRegistration routeAdministrative
Sources (1) · verified against the instrument 20 Oct 2026
In force: 1 Sep 2026
Argentina: ANMAT caps the device import fee at ARS 5 million
Disposición 5461/2026 (dated 27 August, published 28 August 2026) sets a maximum fee of ARS 5,000,000 for medical devices on foreign-trade procedures (ARS 12,000,000 for medicines), keeping the existing scales and percentages. The new fee schedule applies to procedures started on or after 1 September 2026.
What to do. Re-run landed-cost estimates for high-value shipments; the cap matters most for capital equipment.
All devicesFeesImport & licensing
Sources (1) · verified against the instrument 20 Oct 2026
In force: 19 Aug 2026
India: an EU approval now counts towards waiving Indian trials for devices with no predicate, but not for new IVDs
G.S.R. 744(E) adds EU countries to the list of reference countries whose approval (with two years on the market) can waive the Indian clinical investigation for a device with no Indian predicate, decided case by case. New IVDs are approved under a different rule with no reference-country waiver, and need clinical performance data from India.
What to do. For a novel device with two years of EU marketing, ask CDSCO about the waiver. For a novel IVD, budget an Indian clinical performance evaluation.
All devicesIVDReliance & recognitionClinical evidence & trials
Sources (2) · verified against the instrument 19 Oct 2026
European Union
Not a device change
Published: 19 Aug 2026
European Union: the August 2026 joint-assessment eligibility checker and early-information guidance cover medicines, not devices
On 19 August 2026 the Commission updated its guidance on submitting early information for joint clinical assessment and launched an eligibility checker. Both apply to medicinal products, alongside EMA's pre-authorisation forms. Devices are not self-declared into scope: the Commission selects them by implementing decision.
What to do. No action for device makers; watch for the Commission's device selections instead.
All devicesHTA & reimbursement
Sources (1) · verified against the instrument 20 Oct 2026
In force: 21 Jul 2026
India: CDSCO's final guidance on medical device software, including IVD software
The guidance classifies standalone software, including IVD software, and says it reflects current practice rather than a new control. Software embedded in an analyser is part of the analyser; separately supplied software that drives an analyser is an IVD in its own right. A separate CDSCO FAQ says every new software version of an approved IVD needs a post-approval change.
What to do. Classify standalone software on the guidance grid and plan your release cadence around post-approval changes.
Software & AIIVDSoftware & AI rulesClassification
Sources (1) · verified against the instrument 19 Oct 2026
Published: 29 Jun 2026
Switzerland: plans to accept FDA-cleared or approved devices, with ordinances due by Q3 2027
On 30 April 2025 the Federal Council set guidelines for letting FDA-authorised devices onto the Swiss market: private bodies would check conditions in a simplified conformity assessment that takes account of the FDA's work, including Swiss data-protection law, a quality management system and a post-market surveillance plan, with clinical evidence possibly required. In a declaration of 29 June 2026, Switzerland said it intends to amend the ordinances by the third quarter of 2027. No draft ordinance has been published, and today only devices with a Swiss or EU declaration of conformity can be placed on the market.
What to do. If you hold only an FDA authorisation, keep Switzerland on your list but plan entry through CE marking until the ordinances are published.
All devicesReliance & recognitionRegistration route
Sources (2) · verified against the instrument 20 Oct 2026
In force: 1 Jun 2026
South Korea: a pre-submission meeting and parallel review for innovative devices
MFDS put an expedited approval and review process for new drugs, biosimilars and innovative medical devices into effect on 1 June 2026, as part of a plan with a 240-day approval target. Applicants get a checklist of the items most often sent back, can request a face-to-face meeting with reviewers before filing, and review teams work on the file in parallel. MFDS promoted the reforms again on 19 October 2026.
What to do. If you plan a first-of-its-kind device filing in Korea, request the pre-submission meeting before you file.
All devicesRegistration route
Sources (2) · verified against the instrument 19 Oct 2026
Published: 11 May 2026
Great Britain: draft regulations set out three reliance routes for devices approved in Australia, Canada or the US
The draft Medical Devices (Amendment) Regulations 2026, notified to the WTO, name Australia, Canada and the United States as comparable regulators. Route 1 covers basic Class I devices and non-sterile Class A IVDs with no approved-body review; Route 2 covers devices approved by TGA, by Health Canada at Class III or IV, or by FDA, checked by a UK approved body; Route 3 adds scrutiny for 510(k)-cleared Class IIa, IIb and III devices, software, Class D IVDs and devices with an ancillary medicine. Devices that reached the reference market through reliance, companion diagnostics and some others are excluded. The impact survey closed on 19 June 2026 and no start date has been set.
What to do. If you hold an FDA, TGA or Health Canada approval, map your device to a route now, and note that a 510(k) Class IIa or higher device goes to the higher-scrutiny Route 3.
All devicesReliance & recognitionRegistration route
Sources (3) · verified against the instrument 20 Oct 2026
In force: 3 May 2026
Saudi Arabia: new rules on grouping devices into one marketing-authorisation application
SFDA guidance MDS-G28 (version 1.0, 3 May 2026) replaces Annex 15 of the marketing-authorisation requirements (MDS-REQ 1). It sets when devices may share one MDMA application as a family, a system, a procedure pack or an IVD group: the same legal manufacturer and, for most groupings, the same risk class and intended use, with at most five technical files and 50 devices per application. IVDs are grouped by principle of operation and listed test categories, and a standalone product cannot be bundled with a kit that contains it. Applications on the reliance route must follow the same rules.
What to do. Map your portfolio against the family, system and pack rules before you budget Saudi filings; the five-file and 50-item limits decide how many applications you need.
All devicesIVDRegistration routeAdministrative
Sources (1) · verified against the instrument 20 Oct 2026
MalaysiaThailand
In force
In force: 1 May 2026
Malaysia and Thailand: the two-way device reliance programme moves to full implementation
MDA and Thai FDA announced on 1 May 2026 that, after a pilot from 1 February to 30 April 2026, their reliance programme for Class B, C and D devices is fully in place. A Thai-approved device can use MDA's verification route instead of full evaluation. An MDA-approved device can skip Thailand's external expert evaluation, though a full CSDT is still filed. At that date the Thai leg rested on a draft notification; it became law on 6 October 2026.
What to do. If you hold either approval, ask your licence holder in the other country to file under the programme, and keep the labelling identical between the two.
All devicesIVDReliance & recognition
Sources (1) · verified against the instrument 20 Oct 2026
In force: 1 May 2026
Japan: priority review for a US-authorised twin of a Japanese device in shortage
From 1 May 2026 the amended PMD Act allows priority review and priority QMS inspection of an overseas product when a device already approved in Japan is in serious shortage and there is no medically suitable alternative. The overseas product must be identical to the Japanese one and allowed for sale in the United States, the only country named for devices and IVDs. MHLW decides case by case after consultation, and only where a faster partial-change approval cannot fix the shortage. It is not a general fast track for FDA-cleared devices.
What to do. If a Japanese-approved product faces a supply gap, consult MHLW early about importing its US version under this route.
All devicesIVDRegistration routeSupply & shortages
Sources (1) · verified against the instrument 20 Oct 2026
United Kingdom
Comment period closed
Comments closed: 10 Apr 2026
Great Britain: MHRA consulted on accepting CE-marked devices indefinitely
The MHRA consulted from 16 February to 10 April 2026 on three proposals: recognising devices that comply with the EU MDR or IVDR indefinitely; extending acceptance of MDD-certified devices to match the EU dates (for example, to 31 December 2028 instead of 30 June 2028 for Class IIa); and a reliance route for devices classified higher in Great Britain than in the EU. Today CE acceptance is transitional and ends by 30 June 2030 at the latest. No government response has been published yet.
What to do. Keep your CE certificates and UK Responsible Person in place, and do not plan a UKCA conversion for a CE-marked device until the response is out.
All devicesReliance & recognitionRegistration route
Sources (2) · verified against the instrument 20 Oct 2026
In force: 1 Apr 2026
Great Britain: an annual £300 fee per registered GMDN category from 1 April 2026
SI 2026/197 (made 25 February 2026) raises the device registration fee from £261 to £300 and adds an annual £300 maintenance fee for each registered device, charged once per GMDN Level 2 category: further devices in the same category add nothing. The fee year runs 1 April to 31 March. A company may not place a device on the market while it has unpaid fees.
What to do. Count your chargeable GMDN Level 2 categories and budget the annual fee for each.
All devicesFeesAdministrative
Sources (1) · verified against the instrument 20 Oct 2026
In force: 1 Apr 2026
Canada: device licence applications must go through the regulatory enrolment process from 1 April 2026
Since 1 April 2026 manufacturers must file through the Common Electronic Submission Gateway using the regulatory enrolment process (REP), with submissions in the IMDRF table-of-contents format. This covers Class II to IV licence applications and amendments, minor-change faxbacks, private-label licences, and responses to terms and conditions, information requests and suspensions. Investigational testing, establishment licences, Special Access and Part 1.1 applications are outside it. A new applicant must file a company template before it can apply.
What to do. File your company template and put your dossier into the IMDRF table-of-contents structure before your next Canadian application.
All devicesAdministrativeRegistration route
Sources (1) · verified against the instrument 20 Oct 2026
In force: 31 Mar 2026
Canada: new guidance on when a change to a Class III or IV device needs a licence amendment
Health Canada's guidance on interpreting 'significant change' (31 March 2026) sets out, with examples, which changes to a licensed Class III or IV device need an amended licence before the modified device can be sold. It adds that a change to a Class II device used with a Class III or IV device may need an amendment for the higher-risk device. It does not apply to Part 1.1 urgent-public-health authorisations.
What to do. Run your change-control procedure against the guidance's examples, including changes to Class II companions of Class III or IV devices.
All devicesRegistration routePost-market & vigilance
Sources (1) · verified against the instrument 20 Oct 2026
SwitzerlandEuropean Union
Announced
Published: 13 Mar 2026
Switzerland: the Switzerland–EU package that could restore device mutual recognition is signed but not in force
The EU has refused to update the medical-device chapter of the Switzerland–EU Mutual Recognition Agreement since May 2021, so each side treats the other as a third country for devices. The Switzerland–EU package, signed on 2 March 2026 and sent to the Swiss Parliament on 13 March 2026, adds the institutional elements the EU had required for updating the agreement. Until it enters into force and the device chapter is updated, nothing changes: Swiss makers still need an EU authorised representative, and EU makers a CH-REP.
What to do. Keep your CH-REP and EU authorised-representative arrangements in place; there is no date for any change yet.
All devicesReliance & recognition
Sources (2) · verified against the instrument 20 Oct 2026
SingaporeMalaysia
In force
In force: 10 Mar 2026
Singapore: a Malaysian registration now qualifies for HSA's abridged route
Revision 13 of HSA's GN-15 (10 March 2026) adds a regulatory reliance section. Class B, C and D devices that went through full conformity assessment by an MDA-recognised body and are registered with MDA qualify for the abridged evaluation route, for a labelled use identical to the Singapore one. The MDA registration certificate and the conformity certificate replace proof of a reference-agency approval. Devices with a registrable medicinal product and borderline products classified differently by the two authorities are excluded.
What to do. If Malaysia is your first ASEAN registration, plan Singapore next through the abridged route and keep the labelled use identical.
All devicesIVDReliance & recognition
Sources (1) · verified against the instrument 20 Oct 2026
In force: 5 Mar 2026
Saudi Arabia: the revised combination-product guide adds a registration process and a phased full-dossier requirement
Version 2.0 of SFDA's Guidance for Combination Products Classification and Registration (implemented 5 March 2026) keeps assignment by primary mode of action and adds a registration process: you file with the leading sector, which may consult the other. For device-led products, a full MDS-REQ 1 technical file plus an ancillary drug dossier is voluntary from 2027 to 2030 and mandatory from 2030; drug-led products need a full eCTD plus the ancillary device requirements on the same timetable. A classification request costs SAR 1,000, is non-refundable and takes 3 working days; an appeal is free and is lodged within 60 days of the decision.
What to do. If you make a drug-device product, request a classification early and start building the ancillary dossier now, so the 2030 requirement does not force a re-filing.
CombinationClassificationRegistration routeFees
Sources (1) · verified against the instrument 20 Oct 2026
MalaysiaSingapore
In force
In force: 1 Mar 2026
Malaysia: a Singapore registration now leads to a 30-working-day verification
After a pilot from 1 September 2025 to 28 February 2026, MDA accepts Class B, C and D devices listed on Singapore's device register through its verification route from 1 March 2026. HSA states the conformity assessment body review takes 30 working days instead of 60 on the full route, with registration within a further 30 working days. Devices classified differently by MDA and HSA, and Class D devices with an ancillary drug, are excluded.
What to do. If you are registered with HSA, use that registration as the reference for Malaysia and say so in the MeDC@St verification filing.
All devicesIVDReliance & recognition
Sources (2) · verified against the instrument 20 Oct 2026
In force: 15 Feb 2026
Argentina: Class I and II devices authorised in a listed country can be registered by sworn notification
Decree 892/2025 (published 17 December 2025, in force 60 days later, by our count 15 February 2026) and ANMAT Disposición 236/2026 (published 6 February 2026) cover foreign-made Class I and II devices and Class A and B IVDs that need no cold chain. These are registered by a sworn declaration with prior-notification status on ANMAT's systems, and are exempt from local testing if they are authorised and marketed in a country listed in Annex I of the decree, shown by a certificate of free sale no older than 24 months. Otherwise accredited certificates or test reports can be used, or the product goes through ordinary registration. Only an importer licensed by ANMAT can use the route.
What to do. For Class I or II products, get a current certificate of free sale from a listed country and have your licensed importer file the notification.
All devicesIVDReliance & recognitionRegistration routeImport & licensing
Sources (2) · verified against the instrument 20 Oct 2026
In force: 2 Feb 2026
United States: the Quality Management System Regulation, built on ISO 13485, applies from 2 February 2026
The QMSR final rule of 2 February 2024 replaced the device quality system requirements in 21 CFR 820 by incorporating ISO 13485:2016 by reference, with additional FDA requirements, effective 2 February 2026. Technical amendments published in December 2025 updated cross-references in 179 sections of the device regulations and add no new requirements. A draft guidance of 17 November 2025 sets out the quality-system information FDA expects in certain premarket submissions under the QMSR; comments closed on 16 January 2026.
What to do. Map your ISO 13485 system against the QMSR's added requirements, and update procedures and records that still cite the old Quality System Regulation.
All devicesQMS & GMP
Sources (3) · verified against the instrument 20 Oct 2026
In force: 6 Jan 2026
United States: FDA revises its guidance on when decision-support and wellness software are not devices
FDA issued revised final guidances on 6 January 2026; the clinical decision support guidance was re-issued on 29 January. It says FDA intends to exercise enforcement discretion where software otherwise meets the non-device criteria but gives a single recommendation because only one option is clinically appropriate; software that analyses images or signals stays a device. The general wellness guidance, replacing the 2019 version, says a non-invasive product that estimates values such as blood pressure, oxygen saturation or glucose can be a wellness product when the output is solely for wellness, but not when it is meant for screening, diagnosis, monitoring or alerting.
What to do. Re-check your software's device status against the January 2026 texts before deciding whether a US submission is needed.
Software & AISoftware & AI rulesClassification
Sources (2) · verified against the instrument 20 Oct 2026
Published: 16 Dec 2025
European Union: a proposal would move medical devices to the AI Act's lighter Annex I Section B
The Commission's proposal to revise the MDR and IVDR (COM(2025) 1023, Article 4) would move both regulations from Section A to Section B of the AI Act's Annex I. It is still in the Parliament committee; an indicative plenary date is 14 December 2026.
What to do. Keep planning to the 2 August 2028 date that is in force, and watch the December plenary.
Software & AIIVDSoftware & AI rules
Sources (1) · verified against the instrument 19 Oct 2026
AustraliaUnited Kingdom
In force
In force: 1 Dec 2025
Australia: UK approved bodies become comparable overseas regulators
From 1 December 2025 a UK approved body is listed as an overseas regulator for subsection 41BIB(1) of the Therapeutic Goods Act. Evidence it issued can now support ARTG inclusion, alongside notified bodies, MDSAP auditing organisations, Health Canada, HSA, Japan's MHLW and PMDA, and the US FDA.
What to do. If your device holds a UKCA certificate, ask your Australian sponsor to use it as conformity evidence.
All devicesIVDReliance & recognition
Sources (1) · verified against the instrument 20 Oct 2026
In force: 17 Nov 2025
Saudi Arabia: radioactive medical materials need SFDA specification approval per import, and an MDMA where they are devices
SFDA's MDS-REQ 6 was retitled and expanded in version 2.0 (17 November 2025; the current version 2.1 is dated 7 January 2026). The importer files each request in SFDA's MRMR system for approval of the technical and clinical specifications before the Nuclear and Radiological Regulatory Commission licenses the activity, and each approval letter serves one application only. Radioactive materials classified as medical devices must hold a marketing authorisation (MDMA); those classified as drugs need drug registration. Transporters of these materials are now in scope.
What to do. If you supply a radioactive product classified as a device to Saudi Arabia, confirm it holds an MDMA and that your importer is registered in MRMR before the next shipment.
ImplantableActive (powered)Import & licensing
Sources (1) · verified against the instrument 20 Oct 2026
In force: 12 Nov 2025
Mexico: an MDSAP audit counts as meeting the quality-system part of the device GMP standard
COFEPRIS's interpretation criterion for NOM-241-SSA1-2025 (device good manufacturing practice), published 11 November 2025 and in force the next business day (by our count 12 November), recognises MDSAP compliance and MDSAP audit reports as meeting the standard's quality-system requirements for any manufacturing site, without further inspections or audits. For registrations, renewals and changes, an applicant may file a Mexican GMP certificate or an equivalent document. It builds on the March 2025 guidelines that accepted the MDSAP certificate as GMP evidence.
What to do. If your plants are MDSAP-certified, file that certificate as your GMP evidence in Mexico instead of waiting for a COFEPRIS inspection.
All devicesQMS & GMPReliance & recognition
Sources (1) · verified against the instrument 20 Oct 2026
In force: 9 Nov 2025
European Union: procedural rules for joint clinical assessment of devices, with a 100-day dossier deadline
Implementing Regulation (EU) 2025/2086 (17 October 2025) sets how a device's joint clinical assessment runs: the developer submits the dossier within 100 days of the Commission's first request, supplies missing information within 15 days of a second request, and can ask for a scope-explanation meeting. Only Class IIb and III devices with an expert-panel opinion and Class D IVDs with expert-panel views can be selected. It entered into force 20 days after publication on 20 October 2025, by our count 9 November 2025.
What to do. If your device will go through the expert-panel consultation, plan the joint-assessment dossier alongside the clinical evaluation so you can meet 100 days.
ImplantableActive (powered)IVDHTA & reimbursementClinical evidence & trials
Sources (2) · verified against the instrument 20 Oct 2026
In force: 1 Oct 2025
United States: De Novo requests must be filed through eSTAR from 1 October 2025
FDA's final guidance on the electronic submission template for De Novo requests (August 2024) sets the standards, timetable and waiver criteria for filing De Novo requests electronically. From 1 October 2025 FDA requires De Novo requests to be submitted as the guidance describes, in the eSTAR template.
What to do. Build a De Novo request in eSTAR from the start rather than converting a finished dossier.
All devicesRegistration routeAdministrative
Sources (1) · verified against the instrument 20 Oct 2026
In force: 30 Sep 2025
Malaysia: a device approved by a recognised authority goes through verification, with no one-year marketing rule
Circular Letter No. 2 of 2025 (30 September 2025, effective on issue) sets the policy: a device approved by an authority listed in Appendix 1 of guidance MDA/GD/0068 needs only conformity assessment by verification, done by an MDA-registered conformity assessment body, instead of a full assessment. The second edition of GD/0068 (8 September 2025) removed the condition that the device had been marketed for at least a year in the reference jurisdiction. Devices authorised only through special schemes are excluded, and for the US only 510(k) clearance and PMA are listed, not De Novo.
What to do. If you hold a CE (notified body), TGA, Health Canada, Japanese or US 510(k)/PMA approval, ask your Malaysian authorised representative to file through verification, even if the product is newly launched.
All devicesIVDReliance & recognitionRegistration route
Sources (2) · verified against the instrument 20 Oct 2026
In force: 25 Sep 2025
Nigeria: a reliance procedure for devices and IVDs approved by stringent authorities
NAFDAC's reliance guideline (DR&R-GDL-035-01, effective 25 September 2025) covers medical devices and IVDs as well as drugs. A product registered for more than six months by a stringent regulatory authority as WHO defines it (the US, the EU, Japan, Switzerland and Canada, plus Australia, Iceland, Liechtenstein and Norway), and the same as the product filed, gets an abridged review with a decision within 60 working days. The applicant must supply complete, unredacted assessment reports and free-sale and GMP certificates authenticated by a Nigerian embassy, and NAFDAC may still test samples and categorise the plant by GMP risk.
What to do. If you hold a qualifying approval more than six months old, find out now whether you can obtain the unredacted assessment report the route depends on.
All devicesIVDReliance & recognition
Sources (1) · verified against the instrument 20 Oct 2026
In force: 19 Sep 2025
United States: FDA removes its laboratory-developed test rule after a court vacated it
On 31 March 2025 a federal district court vacated FDA's May 2024 rule, which had added laboratories to the definition of IVD manufacturers. A final rule published and effective on 19 September 2025 deletes the words 'including when the manufacturer of these products is a laboratory' from 21 CFR 809.3(a), restoring the earlier text. On our reading, the 2024 rule's phased timetable for laboratories no longer applies.
What to do. If your US plan assumed laboratory-developed tests would need FDA authorisation under the 2024 rule, revisit the competitive and regulatory assumptions.
IVDRegistration routeClassification
Sources (1) · verified against the instrument 20 Oct 2026
In force: 16 Sep 2025
Malaysia: MDSAP certificates now count as quality-system evidence
MDA became an MDSAP affiliate member on 16 September 2025 and now accepts MDSAP audit reports and certificates as evidence of quality-system compliance. Foreign manufacturers can use reports from an MDSAP-recognised auditing organisation for device registration. Local manufacturers can also use them for the establishment licence, but only if the audit was done by an MDA-registered conformity assessment body and auditor.
What to do. If you hold an MDSAP certificate, file it as your QMS evidence in the Malaysian registration.
All devicesQMS & GMP
Sources (1) · verified against the instrument 20 Oct 2026
In force: 1 Sep 2025
Egypt: the 2025 edition of EDA's import registration guide keeps the reference-country basis and adds Croatia and Liechtenstein
The Egyptian Drug Authority reissued its guideline for registering imported and local devices that hold international quality certificates (EDREX:GL.CAMD.002; its history table records 22 July 2025, then version 2 on 1 September 2025, which renamed the inspection departments). It lists 37 reference countries; the 2021 edition, still on EDA's site, listed 35, without Croatia and Liechtenstein. A free-sale certificate from a reference country, or an FDA Certificate to Foreign Government, remains the basis for registration, and reference-country certificates need no consular legalisation when EDA can verify them with the issuer. Registration is valid for ten years.
What to do. If your free-sale certificate comes from Croatia or Liechtenstein, Egypt now lists it as a reference country; otherwise nothing changes in how you file.
All devicesReliance & recognitionImport & licensing
Sources (2) · verified against the instrument 20 Oct 2026
In force: 29 Aug 2025
Mexico: an abbreviated registration route for devices approved by an IMDRF Management Committee member
Guidelines published in the Diario Oficial on 18 July 2025, in force 30 business days later (by our count 29 August 2025), let COFEPRIS register a device that is the same as one approved by a reference authority. For devices the reference authorities are the members of the IMDRF Management Committee, and MDSAP full members for GMP certificates. COFEPRIS checks only that the dossier is complete and has 30 business days to decide (procedure COFEPRIS-04-050). It still assigns the Mexican risk class.
What to do. If you hold an approval from an IMDRF Management Committee member, file on this route with the reference dossier and a Spanish label and instructions.
All devicesIVDReliance & recognitionRegistration route
Sources (1) · verified against the instrument 20 Oct 2026
In force: 11 Aug 2025
Saudi Arabia: where wellness apps and wearables end and medical devices begin
Two SFDA guidances set the line: General Wellness Devices (MDS-G25, 12 March 2025) and Digital Health Products (MDS-G27, 11 August 2025), which covers SaMD, apps, digital therapeutics, wearables, VR/AR and AI. A wellness claim, even one that names a chronic disease such as type 2 diabetes, stays outside device rules if it is about living well with the condition rather than diagnosing or treating it. Two Saudi-specific edges: a wellness product that is invasive, implanted or uses a technology that can pose a risk needs an MDMA even with no medical claim, and once the maker knows clinicians use it for a medical purpose it is treated as a device. MDS-G27 requires wellness labelling, in Arabic and English, stating the product is not for medical use.
What to do. Check your app's or wearable's claims against both guides before launch, and add the Arabic and English not-for-medical-use statement if you sell it as wellness.
Software & AIActive (powered)Software & AI rulesClassificationLabelling
Sources (2) · verified against the instrument 20 Oct 2026
In force: 24 Jul 2025
Argentina: ANMAT no longer authorises each import of Class I and II devices
Disposición 4446/2025 (published 24 June 2025, in force 30 days later, by our count 24 July 2025) ends ANMAT's authorisation of each import of Class I and II devices, for sale or free distribution, by importers it has licensed. Instead the importer files an import notice, as a sworn declaration on the TAD platform, within 48 hours of customs clearance. The change covers only Class I and II, and importers and products must still meet ANMAT's device rules.
What to do. Make sure your Argentine importer files the 48-hour import notice for Class I and II shipments.
All devicesImport & licensing
Sources (1) · verified against the instrument 20 Oct 2026
In force: 16 Jul 2025
European Union: electronic instructions for use allowed for all devices meant for professional users
Implementing Regulation (EU) 2025/1234 (25 June 2025) extends the electronic-IFU rules to every MDR device and accessory intended for professional users, including legacy devices and Annex XVI products for professional use. Before, only certain device types qualified. Where lay people may reasonably use the device too, their instructions must still be on paper. It entered into force 20 days after publication on 26 June 2025, by our count 16 July 2025.
What to do. If your devices are for professional use, check whether switching to electronic IFU cuts printing and translation cost, and keep paper for any lay-user instructions.
All devicesLabelling
Sources (1) · verified against the instrument 20 Oct 2026
Deadline passed: 1 Jul 2025
Israel: draft regulations would register devices approved in recognised countries by risk tier, Class I on a declaration
The Health Ministry published a draft amendment to the 2013 regulations on registering medical equipment in the register, open for public comment from 10 June to 1 July 2025. For equipment registered and marketed in recognised countries it proposes immediate registration on a declaration for low-risk (Class I) equipment, fast registration within 45 working days for medium risk and within 60 working days for medium-to-high risk. We have not confirmed whether the amendment has since been made.
What to do. Until the amendment is confirmed in force, plan Israeli filings on the existing fast-track procedure.
All devicesReliance & recognitionRegistration route
Sources (1) · verified against the instrument 20 Oct 2026
Published: Jun 2025
European Union: revised guidance on whether software is a medical device and how Rule 11 classifies it
MDCG 2019-11 rev.1 (June 2025) is the first revision of the core EU guidance on qualifying and classifying software. It stresses writing a clear intended purpose, adds examples including software intended to treat, clarifies Rule 11(a) with examples of software intended to prevent the risk of illness, expands the section on modules, updates the electronic health record example for the European Health Data Space Regulation, and adds a Class I example.
What to do. Re-read your software's intended purpose and Rule 11 rationale against the revised examples before your next notified-body review.
Software & AISoftware & AI rulesClassification
Sources (1) · verified against the instrument 20 Oct 2026
Published: Jun 2025
European Union: joint guidance on how the AI Act applies to AI medical devices
MDCG 2025-6 / AIB 2025-1 (June 2025), endorsed by both the device and AI boards, explains that an AI medical device is high-risk under Article 6(1) of the AI Act when it needs a notified body under the MDR or IVDR: Class IIa and above, sterile, measuring or reusable-surgical Class I, sterile Class A IVDs and Class B, C and D IVDs. Plain Class I devices, non-sterile Class A IVDs and in-house devices are not high-risk on that basis. It expects a single set of technical documentation covering both laws. It is not legally binding.
What to do. If your AI device needs a notified body, build the AI Act requirements into the same technical file and QMS rather than a parallel one.
Software & AIIVDSoftware & AI rules
Sources (1) · verified against the instrument 20 Oct 2026
In force: 27 Jun 2025
China: NMPA measures to support high-end devices, including simpler AI change registration
NMPA Announcement 2025 No. 63 (27 June 2025), on surgical robots, advanced imaging, AI devices and new biomaterials, keeps innovative special review and extends it to changes of innovative devices. For AI, NMPA says it will simplify change registration where the core algorithm is unchanged and only performance improves, and simplify review of the same AI software function registered on different platforms if equivalence is shown. Most measures are commitments that still need guidance.
What to do. If you hold or plan an AI device registration in China, watch for the change-registration guidance before you plan a full re-review for an algorithm update.
Software & AIActive (powered)ImplantableRegistration routeSoftware & AI rules
Sources (1) · verified against the instrument 20 Oct 2026
In force: 16 Jun 2025
Great Britain: stronger post-market surveillance rules apply from 16 June 2025
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024/1368, made 16 December 2024) insert new post-market surveillance requirements into the Medical Devices Regulations 2002. They came into force 6 months after they were made, on 16 June 2025, and apply to devices placed on the market in Great Britain, including CE-marked devices.
What to do. Make sure your GB post-market surveillance plan, reports and incident timelines follow the 2024 Regulations, not only the EU MDR.
All devicesPost-market & vigilance
Sources (1) · verified against the instrument 20 Oct 2026
In force: 29 Apr 2025
Nigeria: WHO-prequalified IVDs and devices can register through the WHO collaborative procedure
NAFDAC's guideline VBM-R&RA-GDL-014-00 (effective 29 April 2025) lets the holder of a WHO prequalification for an IVD or other medical device register in Nigeria through WHO's Collaborative Registration Procedure, with WHO sharing its assessment and inspection outputs. The product must be the same as the one prequalified, and NAFDAC decides within 60 working days.
What to do. If your IVD is WHO-prequalified, use this route for Nigeria and consent to WHO sharing your assessment with NAFDAC.
IVDAll devicesReliance & recognition
Sources (1) · verified against the instrument 20 Oct 2026
Deadline passed: 7 Apr 2025
United States: FDA draft guidance on what a submission for an AI-enabled device should contain
Draft guidance published on 7 January 2025 recommends the content of marketing submissions for devices with AI-enabled software functions and proposes design, development and documentation practices across the product life cycle, including transparency to users. Comments closed on 7 April 2025. On 20 October 2026 FDA's guidance page still listed it as a draft, not for implementation.
What to do. Use the draft as a checklist for an AI device submission, but do not treat it as a binding requirement.
Software & AISoftware & AI rulesRegistration route
Sources (2) · verified against the instrument 20 Oct 2026
Published: 7 Apr 2025
Kenya: three reliance routes for devices and IVDs, with Saudi Arabia among the reference authorities
The Pharmacy and Poisons Board's reliance guideline (HPT/PER/GUD/091, January 2025, posted 7 April 2025) sets abridged (60 working days for Class B, 90 for C and D), expedited (30 working days, Class C and D) and immediate (14 working days) routes for devices approved by a listed reference authority: Australia, Canada, Japan, the US (510(k) or PMA), EU notified bodies under the MDR or IVDR, Ireland, Switzerland and Saudi Arabia. Class A gets no reliance. The guideline contradicts itself on some points, including which classes may use the immediate route and whether one or two reference approvals are needed. PPB's April 2025 umbrella reliance guideline (HPT/PER/GUD/034) confirms this document governs reliance-based marketing authorisation.
What to do. A Saudi MDMA or a US 510(k) can shorten a Kenyan filing; confirm with PPB through your local agent which route your class qualifies for before you set a timeline.
All devicesIVDReliance & recognition
Sources (2) · verified against the instrument 20 Oct 2026
In force: 5 Feb 2025
Canada: final guidance for machine-learning devices, with predetermined change control plans
Health Canada's pre-market guidance for machine-learning-enabled devices (first published 5 February 2025; current version 1 April 2026) applies to new and amended Class II to IV licence applications. The cover letter should say that the device uses machine learning and whether it has a predetermined change control plan. Changes made within an authorised plan do not need a significant-change amendment but must be documented in the quality system; a change to the intended use, or to the plan itself, needs review first.
What to do. If you will retrain or update a model after launch, propose a change control plan with your first Canadian application.
Software & AISoftware & AI rulesRegistration route
Sources (2) · verified against the instrument 20 Oct 2026
In force: 24 Jan 2025
South Korea: the Digital Medical Products Act takes effect
Law No. 20139 took effect on 24 January 2025. Devices and IVDs that use AI, robotics, information and communication or other designated digital technology are licensed under it, with the Medical Devices Act applying where it is silent. Software makers and importers must obtain a decision that the software meets MFDS's quality management standard, valid three years; the Act also lets real-world data support approvals and changes, and a company selling its own stand-alone software by subscription or download does not need to register as a seller.
What to do. If you sell software or an AI-enabled device in Korea, ask your licence holder how your licence and the software quality conformity decision apply under the Act.
Software & AIActive (powered)IVDSoftware & AI rulesRegistration routeQMS & GMP
Sources (1) · verified against the instrument 20 Oct 2026
In force: 21 Jan 2025
Argentina: new device registration rules and risk classes, including software as a medical device
ANMAT Disposición 64/2025 (published 13 January 2025) brings Mercosur resolution GMC 25/21 into Argentine law: a new technical regulation for registering medical devices, with its own classification rules and a definition of software as a medical device. It repeals Disposición 2318/02. ANMAT applied it to initial registrations from 21 January 2025; a product whose class changes is updated at renewal. On 10 September 2026 ANMAT said that software meeting the definition, including health functions on smartwatches and wearables such as ECG, irregular-rhythm alerts and sleep-apnoea detection, must be registered.
What to do. Check your class under the new rules before renewal, and if you sell health software in Argentina, confirm whether it needs registration.
All devicesSoftware & AIClassificationRegistration routeSoftware & AI rules
Sources (3) · verified against the instrument 20 Oct 2026
In force: 10 Jan 2025
European Union: warn of a supply interruption or discontinuation at least 6 months ahead
Since 10 January 2025, a manufacturer that expects to interrupt or stop supplying a device, where that could foreseeably cause serious harm to patients or public health, must tell the competent authority of the member state where it or its authorised representative is established, and the economic operators, health institutions and healthcare professionals it supplies directly. The notice is due at least 6 months before, other than in exceptional circumstances, and must give the reasons. The rule is the new Article 10a of the MDR and of the IVDR; custom-made devices are excluded under the MDR.
What to do. Add a 6-month supply-exit check to your portfolio and discontinuation decisions, and route the notice through your authorised representative.
All devicesSupply & shortagesPost-market & vigilance
Sources (2) · verified against the instrument 20 Oct 2026
United Arab Emirates
In force
In force: 2 Jan 2025
United Arab Emirates: the federal medical products law takes effect, with a one-year window to comply
Federal Decree-Law No. 38 of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments took effect on 2 January 2025 and repealed Federal Law No. 8 of 2019. Its definition of a medical device expressly includes operating software, wearables and AI-based products. Everyone it covers had one year from that date to come into line, which by our count ended on 2 January 2026; the Cabinet may extend that period, and we have not confirmed whether it did. Regulations made under the 2019 law stay in force until replaced.
What to do. Ask your UAE registration holder whether your listings and its establishment licence have been brought under the 2024 law, and treat AI and wearable products as devices in your UAE plan.
All devicesSoftware & AIAdministrativeSoftware & AI rules
Sources (1) · verified against the instrument 20 Oct 2026
In force: 1 Jan 2025
Switzerland: longer IVD transition periods and no sell-off deadlines, from 1 January 2025
Amendments to the IvDO in force on 1 January 2025 align Switzerland with the EU's IVDR extension. For IVDs that newly need a designated body, the transition runs to December 2027 for Class D, December 2028 for Class C, and December 2029 for Class B and sterile Class A. Certificates issued under the old law remain valid until 31 December 2027. The one-year sell-off deadlines are abolished in both the MedDO and the IvDO, and the simplified designation rule in IvDO Article 87 now has no end date.
What to do. Use the Swiss IVD deadlines, which match the EU's, when planning IVDR certification for Switzerland.
IVDRegistration route
Sources (1) · verified against the instrument 20 Oct 2026
In force: 1 Jan 2025
Vietnam: older import licences and IVD numbers extended to 30 June 2025
Decree 04/2025/ND-CP (1 January 2025, in force on signature) let import licences issued from 2018 to 2021, IVD circulation numbers issued from 2014 to 2019, and imports of Class C and D devices with only a published classification continue until 30 June 2025. It did this by amending Article 76 of Decree 98/2021, the transitional provisions.
What to do. Check that every product you import into Vietnam now holds a marketing authorisation number of its own.
All devicesIVDImport & licensing
Sources (1) · verified against the instrument 20 Oct 2026
No changes match these filters. Clear a filter to see more.
These summaries are for planning. Read the instrument before acting on any of them; this
page is not regulatory advice. A change appears here once it has been read at source, so recent items can
take a few days to arrive. "Not a device change" marks a widely reported headline whose instrument does not
apply to medical devices.