Global Medical Device Policy
Sourced analysis of global medical device regulatory changes and what they mean for industry teams.
FDA's updated provider letter lists five models under an October 20, 2026 heading, while preserving qualified use of existing equipment and exclusions for related supplies. Import restrictions remain product- and facility-specific.
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FDA's October 20 update highlights hypothetical pathways for hospital-specific sepsis models and automated ECG model retraining. The examples connect planned changes with validation, controlled deployment and continued oversight, without authorizing unrestricted learning.
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FDA has finalized its approach to labeling for software distributed by drug sponsors, distinguishing FDA-required labeling from promotional labeling while retaining the separate medical-device framework.
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The UK government intends to recognise EU MDR- and IVDR-compliant devices indefinitely in Great Britain, with separate arrangements for MDD legacy devices. Legislation remains subject to parliamentary approval; UKCA and domestic registration and surveillance obligations continue.
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Australia's November Prescribed List update takes effect on 1 November 2026 under newly registered rules replacing the No. 3 rules.
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The TGA has completed its review of the conditional exclusion for certain digital mental health tools, finding that the criteria may allow higher-risk products to remain outside its oversight. Public consultation on regulatory options is planned for 2026; the update does not establish a final replacement rule or commencement date.
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The TGA is seeking feedback on proposed fees and charges for 2027–28 before requesting Government approval. The consultation closes on 16 November 2026.
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The TGA's review identifies potentially regulated functions in eight of 12 digital scribes. Intended purpose, clinical outputs and conditional CDSS exemptions determine the applicable regulatory position.
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Five Chinese IVD guidance technical document projects cover POCT personnel, public health emergencies and CTC pre-examination processes. All remain at the drafting stage; the POCT project is intended to replace GB/Z 43281-2023.
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MHRA plans an adaptive framework for AI medical devices, a Centre for AI and Digital Health, and stronger lifecycle data and traceability. The 14 October strategy sets future priorities; planned UDI measures remain subject to the parliamentary process.
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PMDA has made its September draft review points for generative AI medical devices available in English. The draft discusses clinical scope, performance testing, supplier dependencies and life-cycle risk management; the translation introduces no newly effective requirements.
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China's 2026 HCV genotyping guidance replaces the earlier overall clinical sample-size wording with recommendations for individual genotypes and subtypes. Analytical coverage, comparator selection and labeling remain important to substantiating the claimed detection range.
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China's 2026 HER2 gene amplification guidance replaces fixed clinical sample counts with a statistical estimation framework for positive and negative agreement. Separate designs for each indication, drug-linked comparators and borderline-sample evaluation remain central to the evidence package.
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Norway proposes to incorporate EU rules on notified body quotations, assessment timelines and re-certification. Comments are due by 9 December 2026; Norwegian commencement remains to be determined, and EU transition rules depend on agreement and certificate expiry dates.
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Mexico's updated blood standard requires HIV, HBV and HCV nucleic acid testing and extends irregular antibody screening to all donors. It provides 180 calendar days before entry into force and a further 180 days for the two testing requirements.
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The Class II rule covers home specimen collection followed by clinical laboratory testing, not at-home result generation. Existing classification controls address the collection device, specimen-specific evidence, shipping integrity and user information.
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The 9 October 2026 rule codifies a classification applicable since November 2023. Its seven groups of special controls connect sensor quality, clinical performance, alarms, usability and labelling; the device type remains subject to 510(k).
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The draft addresses manufacturing licence applications by domestic IVD manufacturers and invites comments within 15 days of publication. It should not be treated as effective guidance or a universal checklist for import projects.
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The non-binding MHLW guidance distinguishes non-clinical equivalence evidence from the human oral clinical evaluation generally needed for implant-related use, while preserving justified exceptions.
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The new hub brings together existing guidance and publications on real-world evidence. Device developers should distinguish the hub’s launch from the dates, status and scope of its linked resources.
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A reproduced CMDE neurostimulator draft details MRI configuration coverage, battery management and remote-programming evidence. Field strength alone does not justify test coverage, and battery evidence includes the interval from warning to loss of power. The copy remains unauthenticated against the official original.
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FDA codified Class II special controls for room-temperature vascular autograft flushing and storage solutions. Six control categories govern the device type, while the original DuraGraft indication’s four-hour duration is product-specific. Developers should distinguish those two sources of requirements.
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Article 9 of Korea’s post-market investigation provisions defines overseas-use experience and requires two evidence groups. Clinical or post-market research is one group; overseas authorization, sales, use and adverse-event analysis form the other. Foreign marketing alone does not establish an exemption.
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MHRA’s September MRI guidance update corrects diagrams and other details; the fifth-edition rewrite was introduced in July. The current guidance explains distinct questions about 7 T heating and implants, hearing-protection ratings and quench venting, rather than a single new September safety regime.
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A reproduced NMPA consultation draft combines general GMP and software provisions in a graded inspection checklist. Its clauses distinguish critical and major controls and specify lifecycle traceability and cloud responsibilities; the current copy remains unauthenticated against the official original.
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NMPA is consulting on a pathway for eligible Class II and III devices with valid domestic registration certificates to be registered by a related applicant in another province. The draft would allow reuse of specified registration materials while retaining testing and quality-system requirements; comments are due October 30, 2026.
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NMPA is consulting on an IVD reagent GMP inspection draft that integrates the general GMP and IVD appendix into 212 inspection items across three risk levels. Comments are due October 10, 2026; the same notice also covers a separate custom-made denture draft.
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An FCC public draft proposes modernizing Part 15 UWB rules and seeks comment on a possible AI-based sensing class. Health-monitoring developers should assess device classification, emissions and measurement methods under the current framework.
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OSHA has issued a preliminary finding on Intertek’s application to add UL 3100 for automated mobile platforms to its NRTL scope. The proposed expansion remains subject to a final decision.
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MFDS issued nonbinding guidance on September 30, 2026, for digital medical software that patients use under healthcare professional diagnosis, direction or supervision. It clarifies application information, separate professional and patient instructions, supporting evidence for standalone software and a disclosure checklist.
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UK guidance lists CPTPP entry into force with Canada from September 1, 2026, following earlier entry with other parties. Medtech businesses should verify origin, destination tariffs and the approval scope of conformity assessment bodies before relying on benefits.
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Canada's September 2026 Domestic Substances List orders add the P flag to 204 polymer identifiers previously assessed as reduced regulatory requirement polymers. The final order covers fewer entries than the 220 proposed in February; suppliers and device manufacturers should confirm that the polymer form supplied still meets the RRR criteria.
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NMPA has opened comment on revised GMP inspection guides for sterile and implantable medical devices. The drafts combine the revised general GMP with the relevant special appendices and classify findings as critical, major, or general; comments are due October 8, 2026.
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FDA has issued draft recommendations for premarket submissions covering certain robotically-assisted surgical devices, including device description, non-clinical testing, software, cybersecurity, human factors, clinical data, and labeling. The draft is not for implementation, and comments are due November 24, 2026.
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The US FCC has opened a public comment period on specific radiofrequency exposure issues remanded in Environmental Health Trust v. FCC, while existing RF exposure limits and applicable compliance requirements remain in effect.
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Australia’s 2026 IChEMS amendment places PFHpS, PFNS, PFDS and related chemical classes in Schedule 7 from January 1, 2027. The instrument confirms restrictions on industrial-chemical uses, but the available sources do not establish a blanket TGA exemption for all medical devices or components.
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New Mexico’s 20.13.2 NMAC requires PFAS labeling for covered products made for sale or distribution after January 1, 2027, but expressly exempts FDA-regulated medical devices, drugs, and their packaging from the rule’s specified prohibitions, reporting, testing, and labeling requirements.
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The US FDA has issued a final order denying an industry petition seeking partial 510(k) premarket notification exemptions for radiology CADe, CADx, and CADt software devices under 21 CFR Part 892.
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The Russian Ministry of Health has enacted Order No. 421n, replacing Order No. 885n to establish updated rules for technical testing, toxicological evaluation, and clinical investigations for state registration.
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The US FCC has issued a final rule barring equipment authorization for devices containing logic-bearing hardware components from Covered List entities, applying prospectively from October 13, 2026.
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The US FDA has issued a final order codifying cardiovascular machine learning-based notification software under 21 CFR 870.2380 as Class II (special controls), establishing a 510(k) pathway while excluding arrhythmia detection.
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MDCG 2020-16 rev.5 clarifies the classification rationale and practical examples for Rule 7 control materials under IVDR, establishing key distinctions between unassigned Class B controls and assay-specific materials.
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The UK Department of Health and Social Care published a Health Bill fact sheet outlining primary legislative powers for the MHRA to directly license medical devices and strengthen global safety data sharing.
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Australia's TGA announced amendments clarifying the Clinical Decision Support System exemption effective 1 November 2026, defining boundaries between excluded software, exempt CDSS, and regulated SaMD.
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Under new Clause 2.2 of Australia's medical device regulations, non-invasive devices containing only saline for flushing or maintaining device patency are reclassified as Class IIa, with a five-year transition for existing products.
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FCC has proposed a framework that would let certain unlicensed devices communicate with satellites on a non-interference basis and is seeking comment through November 9, 2026. Medical-device teams that rely on wireless modules, connected accessories, or supplier RF roadmaps should check whether the proceeding could affect future band planning, coexistence assumptions, or certification strategy.
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EPA has announced the availability of a draft TSCA risk evaluation for 1,2-dichloropropane and is accepting public comments through November 3, 2026. The draft preliminarily identifies unreasonable risk to human health under certain conditions of use; it is an evaluation step, not a final restriction or ban.
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ANVISA has clarified that smart rings currently marketed as wellness or sports products should not be used to diagnose disease, and that products presently available are not regularized for non-invasive glucose or oximetry measurement. The update reinforces that intended medical purpose and promotional claims can determine whether a wearable falls within the medical-device regulatory framework.
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FDA has issued two final 510(k) guidances covering dental composite resin devices and dental curing lights, replacing guidance documents from 2005 and 2006. The final versions update FDA's recommendations for device description, performance testing, and labeling, including clarified shelf-life testing for composite resins and revised radiant-power testing expectations for curing lights.
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MHRA has updated its guidance on medicine parallel import licence applications with more detailed instructions on submission, supporting documents, sample scans, packaging, company functions, and its one-RFI assessment approach. The guidance applies to medicines and should not be treated as a medical-device parallel-import licensing pathway.
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PMDA has updated the currently available timing for face-to-face consultations conducted by its Programmed Medical Device Review Office, with scheduling now shown as November 2026 and later. The update is a consultation-capacity notice rather than a change to the statutory or standard review timeline for SaMD approvals.
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Swissmedic has published its first FAQ on enforcement practice under the Swissmedic Fees Ordinance, effective from 1 September 2026. For medical-device companies, the FAQ sits alongside the already-effective swissdamed registration regime, under which device registration became mandatory on 1 July 2026 and registration fees are charged per UDI-DI.
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South Korea's MFDS has issued a new guide for evaluating the clinical accuracy of non-invasive automated blood pressure monitors, outlining auscultatory and invasive reference methods, subject and test-design requirements, analysis methods, and considerations for pregnant populations in alignment with ISO 81060-2.
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EPA has released a draft TSCA risk evaluation for trans-1,2-dichloroethylene, preliminarily finding that the chemical presents an unreasonable risk to human health driven primarily by certain conditions of use, and is accepting public comment through October 26, 2026. For medical-device-related manufacturers, the practical near-term question is whether the substance appears in cleaning, degreasing, formulation, or supplier processes that may later be affected by TSCA section 6 risk-management activity.
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FCC has issued a correction to the July 31, 2026 final rule on Upper C-Band flexible use, correcting minor editorial errors and the stated number of years in the first and second performance benchmarks. For teams using the rule in wireless planning, certification support, or regulatory summaries, the practical task is to update internal references to the corrected text.
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MFDS has issued guidance on responding to MDSAP-related review scenarios for medical devices in Korea. For manufacturers and Korean import-license holders that already operate under MDSAP, the guidance is relevant to how audit reports and CAPA records may be used to support or simplify Korea-facing inspection and GMP processes.
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MFDS has revised its guidance on priority review designation so patient experience data may be used when applying to designate priority-review drugs. The official MFDS page classifies the update under pharmaceuticals and does not establish that the same PED approach now applies to medical-device priority review.
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Canada has added CAS 68910-05-4 to the Domestic Substances List after completing its new-substance assessment, while retaining Significant New Activity requirements for defined consumer-product and cosmetic uses. The order does not create a general medical-device restriction, but it is relevant upstream materials intelligence where this substance appears in Canadian supply chains.
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Canada has amended its cross-border hazardous-waste and hazardous-recyclable-material rules to clarify that required export permits must be in place before a shipment begins moving, refine waste-related provisions, and prepare for implementation of the Basel Ban Amendment. The new export prohibition to non-Annex VII countries has a separate delayed commencement tied to Canada's ratification of the Ban Amendment.
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EPA has finalized Significant New Use Rules for a batch of PMN chemicals already subject to TSCA section 5(e) Orders, with the rule taking effect on 26 October 2026. Manufacturers, importers, and processors planning a designated significant new use must submit a SNUN at least 90 days in advance and may not begin the activity until EPA completes its review and takes the actions required by its determination.
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FDA is seeking public comment on extending the existing voluntary information collection used for allegations of regulatory misconduct involving medical devices and CDRH-regulated electronic products. The notice does not create new enforcement standards; it continues the existing reporting channel, under which anyone may submit allegations and may provide supporting information anonymously or with contact details.
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OPSS refreshed the featured recalls on its Product Recalls and Alerts page on 25 August 2026. The update is routine rather than a new recall rule, and the portal expressly excludes medicines and medical devices, which remain subject to separate MHRA safety-alert and recall channels.
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The 25 August 2026 update to the UK AI Research Resource page only adds AMD to the partner list; it does not introduce a new AI or digital-health regulatory requirement. For healthcare AI and R&D teams, the more important opportunity is the existing access to Isambard-AI and Dawn through routes such as Rapid Access and Gateway.
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EPA has published its May 2026 TSCA Section 5 statements of findings for certain new-chemical and significant-new-use submissions determined not likely to present an unreasonable risk under the reviewed conditions of use. The notice is not a new medical-device restriction, but it can be useful upstream intelligence when suppliers introduce new polymers, additives, coatings, or other chemical inputs.
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FDA has formally published Recognition List 066 in the Federal Register, covering additions, replacements, and revisions to recognized consensus standards used in medical-device premarket submissions. Manufacturers should review not only the new standard editions but also FDA recognition numbers, complete versus partial recognition, and transition deadlines for declarations of conformity.
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The Department for Business and Trade updated its Great Britain UKCA / CE market guide on August 21, 2026, with a limited wording change to the declaration-of-conformity template. The wider guide remains a useful operating reference for non-medical products covered by the continued-recognition framework, including CE access, Fast-Track UKCA, marking placement, importer details, and labelling flexibilities.
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The Philippine FDA is consulting on a draft Administrative Order that would establish a more complete regulatory framework for medical device clinical investigations and IVD clinical performance studies, including sponsor and CRO licensing, ethics review, FDA study approvals, safety reporting, and inspections. The draft remains under consultation and may change before final issuance.
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FDA’s general draft guidance on Predetermined Change Control Plans remains in draft status, but section 515C of the FD&C Act is already in effect and manufacturers may submit PCCPs today. The draft explains what planned device modifications may be appropriate for a PCCP and the information FDA expects manufacturers to provide.
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FDA has issued a discussion paper seeking feedback on how generative AI-enabled medical devices should be assessed across risk classification, premarket evaluation, and postmarket monitoring. The paper outlines possible approaches including a two-axis risk framework and competency-based premarket assessment, but it does not establish new regulatory requirements.
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HSA’s supplementary change-notification guidance for EU MDR/IVDR transition changes is no longer current and is listed as archived. Registrants should now assess EU-driven labelling, IFU, and other changes under the current GN-21 R7 change-notification framework.
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Mandatory device registration in swissdamed began on 1 July 2026, with a general transition period through 31 December 2026. Economic-operator CHRN registration predates this milestone, while devices involved in serious incidents, FSCAs, or trend reporting must be registered immediately without using the transition period.
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Japan is adding MCCP, LC-PFCA and related substances to its Class I Specified Chemical Substances regime, with related import restrictions taking full effect on 22 November 2026. Medical device teams should first confirm product scope and the PMD Act/CSCL interface before treating finished devices as import-banned products.
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