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
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
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
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United States: FDA draft guidance on premarket submissions for robotically-assisted surgical devices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
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
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
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
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 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
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: 19 Oct 2026
South Korea: MFDS announces a pre-submission meeting and parallel review for new-technology devices
MFDS announced reforms covering new drugs, biosimilars and new-technology medical devices: a checklist for preparing the application, a face-to-face meeting with MFDS before you file, and simultaneous review by teams assigned per review item. No effective date or legal instrument has been published.
What to do. If you plan a novel device filing in Korea, watch for the implementing notice before you build the pre-submission meeting into your timeline.
All devicesRegistration route
Sources (1) · verified against the instrument 19 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-trial filings and trial registration move onto one online platform
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. Approval rules are unchanged.
What to do. Check every running Taiwanese device trial is on the platform and current, and plan the December update.
All devicesClinical evidence & trials
Sources (2) · 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: 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
In force: 21 Sep 2026
Taiwan: rules for recruiting participants into device trials
TFDA's notes (21 September 2026) say recruitment material needs ethics-committee approval and must not name the investigational device or the company, stress approval, claim safety or superiority, or promise free product. Referral fees are not allowed; digital recruitment is allowed in principle.
What to do. Have recruitment copy checked against the notes before it goes to the ethics committee.
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
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: 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: 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: 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
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
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: 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
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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.