This is the first of a monthly note on what changed in medical device regulation, written for manufacturers selling in more than one market. It covers mid-August to 19 October 2026. Each item answers three questions: what changed, who it affects, and what to do about it. Every item is checked against the authority's own instrument, and we say so where it was not. Where we have written a longer piece on an item, we link to it.
The short version: the next six weeks are crowded. An EU consultation window closes on 21 October, Australia and China change their rules on 1 November, and the first EUDAMED registration deadline falls on 27 November. Entry got easier in India, South Korea, Vietnam and Taiwan, and a US exemption widened. Two markets got more expensive, and two widely expected changes did not happen.
If you make software or AI, three markets moved this period, and not in the same direction. Australia narrows its exemption for clinical decision support software from 1 November. Indonesia now requires some imported diagnostic AI to be validated in Indonesia within a year of approval. The EU pushed the AI Act's high-risk requirements for AI medical devices back a year, to August 2028. One product can now face three different clocks in three markets, so plan them together.
Deadlines
European Union — the first devices picked for joint clinical assessment, and a window that closes 21 October
What changed. Commission Implementing Decision C(2026) 7113 of 2 October 2026 picked the first two medical devices for joint clinical assessment (JCA) under the EU's Health Technology Assessment Regulation, (EU) 2021/2282. Both are transcatheter mitral valve replacement systems, and both were already CE-certified when they were picked: Edwards Lifesciences' SAPIEN M3 and HighLife SAS's trans-septal mitral valve replacement system. Under Implementing Regulation (EU) 2025/2086, the company then has 100 days from the Commission's request to file its dossier, extendable by up to 30 days. The Commission says it expects to select devices quarterly.
Who it affects. Only devices that receive an MDR expert-panel opinion can be selected: Class III implants, Class IIb devices that administer or remove a medicinal product, and Class D IVDs on which an expert panel gives its views. On our reading, stand-alone software cannot be selected. A JCA does not set a price or a reimbursement decision, and there is no fee. Member states must give the report due consideration and may not ask again for evidence already submitted. The real cost is a 100-day dossier built against comparators the member states choose, and the dossier is then published.
What to do. The one lever a company has is a joint scientific consultation, which has to be requested while the pivotal study is still a plan. The last 2026 request window closes on 21 October 2026. Consultations carry no fee in 2026, but the work programme plans only two to five for devices this year. If your device will go through the MDR expert-panel consultation and you miss this window, watch for the 2027 windows. Either way, plan the JCA dossier alongside your MDR clinical evaluation, not after it. We explain the procedure in what the first selection means for a high-risk device company.
China — the new device GMP applies from 1 November
What changed. The NMPA's revised Good Manufacturing Practice for medical devices (Announcement 2025 No. 107, published 4 November 2025) replaces the 2014 version on 1 November 2026. It runs to 132 articles. It separates production release from release to market, and it brings outsourced design, manufacturing and testing explicitly inside the quality system.
Who it affects. Registrants and their contract manufacturers. Overseas registrants should assume that their plants will be measured against the new text in any NMPA overseas inspection. That is our reading; the announcement itself is written for registrants generally.
What to do. If you rely on a contract manufacturer, check that your quality agreement describes the controls the new rules expect you to hold over it.
European Union — register your existing devices in EUDAMED by 27 November
What changed. Under Regulation (EU) 2024/1860, the first EUDAMED modules became mandatory on 28 May 2026. Devices that were already on the market before that date have to be registered in the UDI/device module within twelve months of the Commission's notice, which was published on 27 November 2025. That puts the deadline at 27 November 2026. Certificates issued before May 2026 have until 28 May 2027.
Who it affects. Every manufacturer with devices on the EU market. If you are outside the EU, your actor registration and your authorised representative's mandate have to be in place before any device can be entered.
What to do. Count the Basic UDI-DIs you need to enter now, not in November. For a broad catalogue this is weeks of data work, and your authorised representative will have every other client asking at the same time.
Software and AI
Australia — the exemption for clinical decision support software narrows on 1 November
What changed. The Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026 (F2026L01167, made 3 September and registered 7 September 2026) replace the exemption for clinical decision support software in the Medical Devices Regulations (Schedule 4, item 2.15) from 1 November 2026. To stay exempt, software must meet five conditions. It must be intended only to make a recommendation that assists a health professional's decision. It must not process, analyse, compress or decompress a medical image or signal from another device. It must not replace the professional's clinical judgement. It must not itself make a diagnosis or treatment decision, and that includes in-vitro diagnostic software. And it must display the clinical guidelines, calculations or logic behind each recommendation, so that the professional can readily interpret and verify it while using the software.
Who it affects. Sponsors and makers of clinical decision support software, including AI tools, that are supplied in Australia without ARTG inclusion on the strength of this exemption. The new wording also applies to software made before 1 November that is intended to be used after it (new regulation 11.90). We found no transition period in the instrument.
What to do. Before 1 November, test each exempt product against all five conditions. On our reading, the requirement to show the logic is the hardest for machine-learning tools to meet, because a model's output is rarely traceable to a guideline a clinician can check. A product that fails any condition needs an ARTG inclusion plan, or its claims need to change. We set out the conditions in more detail in Australia's narrower exemption for decision support software.
Indonesia — imported diagnostic AI must be validated locally within a year of approval
What changed. Ministry of Health Decree HK.01.07/MENKES/951/2026 (KMK 951/2026), the guideline on marketing authorisation for software-based medical devices, took effect on 7 September 2026, the day it was signed. Imported software needs a local clinical validation in Indonesia if it has been further developed or retrained on data representing the Indonesian population, or if it uses moderate- to high-risk AI for diagnosis, screening or clinical decisions.
What the validation involves. The decree describes it as an evaluation showing that the software produces clinically meaningful output for its intended use in the Indonesian target population, taking account of that population, local clinical practice, data sources and the setting of use. It can be carried out at a hospital, a university, an accredited laboratory or a Ministry of Health technical unit. It can run in parallel with the marketing authorisation (izin edar) application, which is filed with the manufacturer's own clinical and performance evidence. The results are due within one year of the authorisation being issued. The decree lists sensitivity, specificity and positive and negative predictive values among the parameters of clinical validation, and asks for local validation to be risk-based and proportionate. It does not set a study design or a sample size. If the local results differ significantly from the original clinical evidence, the ministry may take administrative action.
Two further points matter to startups and AI developers. Software that lacks enough clinical evidence on the Indonesian population can use an independent clinical trial or a regulatory sandbox, and a digital-health product must have reached technology readiness level 9 (proven in its real operating environment) before it applies. A device built on a generative model or a large language model must also document how its output is controlled, how the risk of hallucination is mitigated, the limits on its use, and how the accuracy of the medical information it produces is evaluated.
Who it affects. Foreign software and AI vendors and their Indonesian licence holders, and local digital-health developers.
What to do. For any imported AI used in diagnosis, screening or triage, budget a validation study with an Indonesian hospital, university or accredited laboratory. You do not have to wait for it before filing, but the one-year clock starts when the authorisation is issued.
European Union — AI Act high-risk requirements for AI medical devices move to 2 August 2028
What changed. Regulation (EU) 2026/1744, the Digital Omnibus on AI (adopted 8 July, in force 27 July 2026), moves the date from which the AI Act's high-risk requirements apply to AI systems in products covered by its Annex I, which include medical devices and IVDs. The new date is 2 August 2028, a year later than before. The same regulation moved machinery out of direct AI Act application, but it left the MDR and IVDR where they were.
Who it affects. Every AI device company that needs a notified body. Under Article 6(1) of the AI Act, an AI system in a medical device is high-risk only if the device needs a third-party conformity assessment, and most clinical decision software is Class IIa or above under the MDR.
What to do. Certify under the MDR now, and build your quality system so that it can take on the AI Act's requirements by August 2028. The MDR/IVDR revision described below would change this again, but it is a proposal. Plan against the regulation in force. We compare the EU with Japan and Great Britain in AI medical devices in three markets.
Doors that opened
India — an EU approval now counts for a new device with no predicate, but not for a new IVD
What changed. The Medical Devices (Third Amendment) Rules, 2026 (G.S.R. 744(E), dated 14 August and in force on publication in the Gazette on 19 August 2026) add European Union countries to the list of jurisdictions whose approval can stand in for a pre-approval clinical investigation in India for a new device with no Indian predicate (rule 63). The UK, US, Australia, Canada and Japan were already on it.
Who it affects. CE-marked manufacturers with a genuinely novel device, other than an IVD, and none of the other qualifying approvals. Until August, that company faced a clinical investigation in India before approval. It may now not.
The conditions. The device must have been approved and marketed in the reference country for at least two years. The applicant must undertake a post-marketing clinical investigation in India. And the decision is made case by case with CDSCO's expert committee, so this is a waiver you apply for, not one you are entitled to.
Not for a new IVD. India approves a new IVD (one with no approved equivalent in India) under a different rule, rule 64, which has no reference-country waiver. Its data requirement is clinical performance evaluation carried out in India (Fourth Schedule, Part IV(b)). G.S.R. 744(E) did not amend rule 64. So a CE-marked IVD with no Indian equivalent still needs a performance evaluation in India before approval. There are two exceptions: Class A new IVDs may not need clinical performance data, and CDSCO may abbreviate, defer or waive the data for serious or life-threatening diseases, diseases of special relevance to India, emergencies, or conditions for which no diagnostic is available in India. We cover the rest of India's 2026 IVD changes in India's 2026 IVD changes: new guidance, the same rules.
What to do. If India was ruled out because of clinical cost and your device is not an IVD, look again. Check the two-year clock against your CE date and budget the post-marketing study instead of a pre-approval one. If it is a new IVD, nothing changed: plan the Indian performance evaluation.
South Korea — Class 2 review and certification in one application
What changed. From 30 September, the Ministry of Food and Drug Safety lets an applicant apply for the technical-document review and the Class 2 certification together. Until now the review came first, from one of eight designated review bodies, and the certification was a second application with the result attached. MFDS puts the old route at about 40 days in practice. The new application form sets a 25-day processing period. The old two-step route stays available.
The route was tested on Class 2 in-vitro diagnostics from March to May. It is now open to Class 2 certification generally, and it covers imported devices as well as domestic ones. The rule change behind it is still in consultation until 26 October and formally takes effect on 10 December. MFDS chose to apply it immediately rather than wait.
Who it affects. More foreign manufacturers than you might expect. As at 19 October 2026, 13,330 of the 28,435 Class 2 device records in our Korean corpus (47%) are held by import licensees. In Korea it is that licensee, not you, who files, so the speed-up reaches you only if your licence holder uses the new route.
What to do. Ask your Korean licence holder which route your next Class 2 filing will take. Plan around 25 days, but treat it as the authority's processing period, not your calendar time to first sale.
In force since 1 June 2026, restated on 19 October. 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. It has three parts: a checklist of the items most often sent back for more information or slowest to prepare, a face-to-face meeting with MFDS reviewers before you apply, and parallel review by teams dedicated to each part of the file. MFDS promoted the reforms again on 19 October. For a company bringing a first-of-its-kind device to Korea, the pre-application meeting is the part to use. (Corrected 20 October 2026: an earlier version of this item said the reforms had no start date.)
United States — the 510(k) exemption for workplace drug tests now covers federal testing programmes
What changed. A final order published on 6 October 2026 (Federal Register document 2026-20448) covers 14 drug-of-abuse test types under 21 CFR 862, among them amphetamine, benzodiazepine, cannabinoid, cocaine and opiate tests. Tests for employment and insurance testing were already exempt from 510(k), except when they were intended for federal drug-testing programmes. The order removes that exception. Two conditions remain: the labelling must say the test is intended solely for employment and insurance testing, and the device must stay within the general limits on exemptions in 21 CFR 862.9. Fentanyl tests fall under the opiate regulation, so they are included.
What it does not do. It does not exempt clinical or point-of-care drug tests, or anything outside employment and insurance testing.
Who it affects. Makers of workplace drug screens, including small companies for which a 510(k) was the main cost of bringing a new screen to market.
What to do. If you sell, or plan to sell, a drug screen only for employment or insurance testing, including to federal programmes, check that your labelling carries the required statement. A new product within those limits no longer needs a 510(k).
Vietnam — an apostille replaces consular legalisation
What changed. Decree 293/2026/NĐ-CP, effective 11 September 2026, accepts an apostille in place of consular legalisation for public documents from Apostille Convention states.
Who it affects. Every foreign registration dossier. Certificates of free sale, notarised authorisation letters and ISO certificates typically pass through the legalisation chain, which is often among the slowest steps in assembling a Vietnamese file.
What to do. Check with your registration holder before you drop legalisation. A decree in force and a registration desk that has adjusted its checklist are two different things, and we have not yet confirmed the second.
Taiwan — registration filing moved online on 1 October
What changed. From 1 October 2026, the TFDA accepts colour scans in place of posted paper originals for registration, variation and renewal, and it no longer issues paper approved copies of labels, IFUs and packaging. Both measures are formally a trial.
Who it affects. Licence holders, and through them every foreign manufacturer with a Taiwanese renewal coming up.
What to do. Confirm your licence holder has your documents as clean colour PDFs. TFDA will no longer stamp a paper approved copy of your label, so keep your own controlled copy of the approved version.
Taiwan — device trials move onto one platform
What changed. Taiwan's device GCP regulation requires the sponsor to register each trial on a web page the authority designates, within 30 days of approval and of any approved amendment, and to update it every June and December (Art. 7). By an announcement dated 30 September, the Ministry of Health and Welfare designated the TFDA's Digital Medical Device Clinical Trial Platform (mdctp.fda.gov.tw) as that page from 1 October 2026. From 5 October, revised application instructions send every new application, amendment, progress report and final report through the same platform, with the application form, the Chinese protocol summary and the site enrolment table completed online. Separately, notes the TFDA issued on 21 September say recruitment advertising may not name the investigational device or the company. They apply to trials that need only ethics committee review as well as to trials that need TFDA approval.
Whether a trial needs approval, and what it must show, did not change. For a startup choosing where to run a first study, Taiwan's long-standing rules matter more than the new filing mechanics. Some low-risk trials need only an ethics committee, and a trial with an approved US IDE gets a simplified procedure.
Who it affects. Sponsors with a trial running or planned in Taiwan, and the Taiwanese firm or trial site that files for them.
What to do. Check that every trial you run in Taiwan is on the platform and current before the December update. Remove product and company names from recruitment copy before it goes to the ethics committee. We go through the changes, and the rules that did not change, in running a device trial in Taiwan.
Costs
United States — FY2027 user fees apply from 1 October
| Fee | FY2026 | FY2027 | Small business FY2027 |
|---|---|---|---|
| 510(k) | $26,067 | $28,653 | $7,163 |
| De Novo | $173,782 | $191,020 | $47,755 |
| PMA | $579,272 | $636,732 | $159,183 |
| Establishment registration (annual) | $11,423 | $13,785 | no reduction |
Submission fees rose about 10%. The annual establishment fee rose 21%, and it has no small-business rate. For a company that is registered with FDA but not yet selling much in the US, that is now the line to watch. Source: 91 FR 48134, 30 July 2026.
United Kingdom — a proposed 70% rise in the annual registration fee
What changed. Since 1 April 2026, Great Britain has charged an annual £300 for each GMDN category in which a manufacturer has devices registered (SI 2026/197). In a consultation that ran from 17 August to 25 September, the MHRA proposed raising that to £511 per category from 1 April 2027. It also proposed raising a device regulatory advice meeting from £987 to £2,245. The government's response has not been published.
Who it affects. Manufacturers whose catalogue spans many device types. The fee scales with how many different kinds of device you make, not with your size. The MHRA has estimated that about 60% of manufacturers pay a single charge. The rest pay several.
What to do. Count your chargeable GMDN categories and budget the 2027/28 figure now. It is a proposal, but the direction is clear.
Argentina — a ceiling on the import fee for devices
What changed. ANMAT Disposición 5461/2026 (published 28 August, applying to procedures started from 1 September) caps the ANMAT import fee for medical devices at ARS 5,000,000. The fee itself is unchanged at 1.25–1.5% of FOB value, so the cap starts to bite on shipments above roughly ARS 400 million FOB.
Who it affects. Importers of high-value devices. ANMAT stopped intervening in Class I and II imports in 2025, so in practice this matters most for Class III and IV.
What to do. Not much, unless you ship capital equipment in large consignments. In that case, re-run your landed-cost model.
What did not change
United States — no 510(k) exemption for radiology AI
A petition asked FDA to exempt four types of radiology computer-aided detection, diagnosis and triage software from 510(k). FDA denied it, and confirmed the denial in a final order on 17 September (91 FR 58817). Manufacturers of those devices must still obtain clearance. The Federal Register headline reads "Exemption From Premarket Notification", which is easy to misread at a glance. It is a denial.
European Union — the MDR/IVDR revision is still in committee
The targeted revision of the MDR and IVDR (2025/0404(COD)) is still awaiting a committee vote in Parliament, with an indicative plenary date of 14 December 2026. Nothing in it has changed your obligations yet. Among other things, it would move medical devices and IVDs to Section B of the AI Act's Annex I, which would take them out of the AI Act's direct high-risk requirements. Plan to the current MDR and IVDR dates, and to the AI Act date above, not to the proposal.
Also on file in the US
Robotically-assisted surgical devices — draft guidance, comments by 24 November
FDA's draft guidance "Robotically-Assisted Surgical Devices — Premarket Submissions" (notice of availability 25 September 2026, 91 FR 60967; docket FDA-2026-N-9505) sets out the bench, software, cybersecurity, human factors, animal and clinical evidence FDA expects in a premarket submission for a teleoperated surgical robot. Its most useful proposal is an "umbrella and covered procedure" approach. Data from a complex, higher-risk procedure can support authorisation for less complex procedures in the same surgical specialty, often without data specific to each one. Autonomous robots, remotely teleoperated systems and intravascular use are outside its scope. It is a draft and not for implementation. Comments are due by 24 November 2026. For a startup with one robot and several intended procedures, the umbrella approach may decide how many procedures its first study has to cover. That is our reading of a draft.
- Digital breast tomosynthesis: proposed Class III → II. Comments closed 9 October.
- Cystoscopic systems for bladder cancer detection (diagnostic endoscopic light sources): proposed Class III → II. Comments closed 16 October.
- A list of accessories proposed for Class I, separate from their parent devices and exempt from 510(k). Comments closed 16 October.
- In-situ hybridization tests tied to an approved oncology therapy: final Class III → II, effective 16 September.
The calendar
- 21 October — the last 2026 request window for EU joint scientific consultations closes
- 26 October — comments close on Korea's one-stop rule change
- 1 November — Australia's narrower exemption for clinical decision support software applies
- 1 November — China's new device GMP applies
- 24 November — comments close on FDA's draft guidance for robotically-assisted surgical devices
- 27 November — EUDAMED registration deadline for devices already on the EU market
- December — the twice-yearly update of trial entries on Taiwan's platform; on our reading, the first under the new designation
- 10 December — Korea's one-stop rule formally takes effect
- 14 December — indicative European Parliament plenary on the MDR/IVDR revision
- 1 April 2027 — proposed start of the UK's £511 annual fee
- 28 May 2027 — EUDAMED deadline for certificates issued before May 2026
- 2 August 2028 — the AI Act's high-risk requirements apply to AI medical devices and IVDs, unless the MDR/IVDR revision changes this first
Two clocks run from your own dates rather than the calendar: in Indonesia, local validation results for imported AI are due within one year of your authorisation, and in the EU, a selected device's JCA dossier is due 100 days after the Commission's request.
A rule change is easy to read and hard to apply across a portfolio. What it means for you depends on which of your products are registered where, who holds each licence, and when each one renews. That is the question our market assessments are built to answer.