Industry News

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.

Breaking News | New Mandatory National Standard GB 28480-2026 for Jewelry Released: Comprehensive Safety Upgrade Reshapes the Industry!

On March 31, 2026, the State Administration for Market Regulation (SAMR) and the Standardization Administration of China (SAC) jointly issued the new mandatory national standard GB 28480-2026 "Jewelry - Safety Technical Requirements", replacing GB 28480-2012 "Ornaments - Limitation of Hazardous Elements", which has been in force for nearly 14 years. The new standard will take effect on April 1, 2027, with a 12-month transition period.

Safeguarding Food Contact Safety – Control of Volatile Organic Compounds (VOC) under GB 4806.16-2025

GB 4806.16-2025 National Food Safety Standard – Silicone Rubber Materials and Articles for Food Contact was issued in September 2025 and will be enforced mandatorily in September 2026. The standard introduces a mandatory limit for volatile organic compounds (VOC/volatile matter), directly targeting residual solvents, low-molecular-weight siloxanes, off-odors, and safety risks. This marks a critical gateway for compliance and quality upgrading of food-contact silicone materials.

Typical EU RAPEX Notifications on Fluorinated Compounds (PFAS/PFOA/PFCAs)

RAPEX, as the EU's rapid alert system for non-food dangerous products, has issued multiple notification cases for fluorinated compounds such as PFAS, PFOA and PFCAs, covering clothing, textiles, outdoor equipment and other product categories. These notifications reflect the EU's strict regulatory requirements and high-intensity law enforcement for PFAS residues in consumer products, and also bring clear compliance challenges to global manufacturers, exporters and cross-border e-commerce platforms.

Summary Report on Cosmetic Supervision and Sampling Inspection in China-March 2026

In March 2026, the Shanghai Municipal, Fujian Provincial, Hubei Provincial, and Anhui Provincial Medical Products Administrations successively issued announcements regarding cosmetic supervision and sampling inspections. A total of 12 batches of products were found to be non-compliant. This summary of the announcements aims to help enterprises stay informed of evolving regulatory trends and strengthen their quality management and compliance awareness.