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.
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.
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.
FDA’s general draft guidance on Predetermined Change Control Plans remains in draft status, but section 515C of the FD&C Act is already in effect and manufacturers may submit PCCPs today.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.
Published
United States · Artificial Intelligence Regulation
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.
HSA’s supplementary change-notification guidance for EU MDR/IVDR transition changes is no longer current and is listed as archived.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.
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.
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.