Topic archive
MedTech Current publications and recall entries tagged Environmental & Chemical Compliance.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.