Topic archive

PFAS

MedTech Current publications and recall entries tagged PFAS.

Regulatory Intelligence

Australia Adds PFHpS, PFNS and PFDS to IChEMS Schedule 7 From 1 January 2027

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.

Regulatory Intelligence

New Mexico’s 2027 PFAS Rules Exempt FDA-Regulated Medical Devices from Labeling

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.

Regulatory Intelligence

Japan Tightens MCCP and LC-PFCA Controls — Do Medical Device Companies Need to Act?

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.