tags

China
Medical Devices
PFAS Regulatory Wave: Compliance Challenges & Solutions for Medical Devices

Per- and Polyfluoroalkyl Substances (PFAS), commonly known as "forever chemicals", feature extremely stable carbon-fluorine bonds, high bioaccumulation potential and suspected endocrine disrupting properties, leading to stringent regulatory restrictions worldwide. According to OECD statistics, the PFAS family comprises over 10,000 substances. Fluoropolymers including Polytetrafluoroethylene (PTFE), FEP, PFA, PVDF and PCTFE are widely applied in cardiovascular catheters, implant coatings, pacemaker wire insulation, as well as sterile high-barrier packaging for medical devices.

CIRS C&K Testing Officially Opens its New Toxicology Laboratory

Hangzhou CIRS C&K Testing Technology Co., Ltd. officially inaugurated its new toxicology laboratory in August. Located in the Tianhe High-tech Industrial Park in the Binjiang District of Hangzhou, Zhejiang Province, this lab is to provide toxicological tests and research services to industries such as cosmetics, medical devices, health products, specialty foods, and pharmaceuticals.