Topic archive
MedTech Current publications and recall entries tagged Registration & Market Access.
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.
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.
Australia's November Prescribed List update takes effect on 1 November 2026 under newly registered rules replacing the No. 3 rules.
The TGA is seeking feedback on proposed fees and charges for 2027–28 before requesting Government approval. The consultation closes on 16 November 2026.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.