China has formally launched and enforced its unified Medical Device Vigilance System, built on the newly issued Good Practice for Medical Device Vigilance (Trial) and a full set of supporting guidelines, marking a major upgrade of post-market surveillance (PMS) regulation covering the full product lifecycle. The regime places registrant responsibility at its core and establishes mandatory requirements for vigilance organization, data collection, risk control, and standardized reporting for all medical devices sold in China.

Explore CIRS’s redesigned Cosmetics section, now live, featuring an intuitive user experience and comprehensive cosmetic testing and regulatory services for global compliance.

In 2026, China’s NMPA has intensified its overseas inspections of medical device manufacturers, with 33 companies targeted for unannounced on-site or remote audits. The new version of the Medical Device Good Manufacturing Practice (GMP) will take effect in November 2026, emphasizing data authenticity, lifecycle traceability, risk management, and contract manufacturing controls. Several overseas companies have already faced import suspensions due to compliance failures. To maintain market access, overseas manufacturers are advised to proactively conduct self-audits, respond quickly to inspection notices, and implement corrective actions. Consulting support is available to help navigate the stricter regulatory landscape.

Thank you very much for your long-standing support and interest in CIRS Group. The 93rd China International Medical Equipment Fair (Spring) – CMEF 2026 will be held from April 9 to 12, 2026 at the National Exhibition and Convention Center (Shanghai). We sincerely invite you to join this grand event and witness the cutting-edge developments and innovative achievements in the medical device industry.

On March 22, 2026, Delegation from the French laboratory Helioscience and the German raw material supplier Uviva visited CIRS Testing. David Wan, Head of Strategic Development at CIRS Group and Managing Director of CIRS Europe, alongside the CIRS Testing team, warmly welcomed the visitors. The gathering facilitated dynamic discussions regarding emerging industry trends and opportunities for expanded collaboration within the testing sector.

The medical device technical team of CIRS Group was invited to attend the event, and jointly held a special seminar on FDA & CE MDR Certification and NMPA Clinical Evaluation with the organizer. Empowering Chinese, Korean and global medical device enterprises to comply with regulations and expand overseas with professional regulatory services, CIRS Group has gained high attention and wide recognition from the industry.

Our LinkedIn page has officially reached 5,000+ followers, and we want to take a moment to say thank you.

Recently, the Environmental Product Declaration (EPD) Promotion Centre formally announced the list of 11 Life Cycle Assessment (LCA) consulting service providers. CIRS Group secured one spot due to its accumulated technical expertise and professional capabilities in dual-carbon services. This marks the recognition of CIRS Group LCA consulting capabilities, thus enabling it to continue delivering more compliant and internationally compatible technical support for corporate green transitions.

The Medical Device Master File (MFs) registration system is a key initiative. It provides an excellent pathway for global suppliers of raw materials, critical components, software, and manufacturing processes to protect their intellectual property and efficiently support their Chinese clients in completing product registration.

On October 16, 2025, the Shanghai Municipal Medical Products Administration, Shanghai Municipal Health Commission, and Shanghai Customs jointly issued the Shanghai Pilot Work Plan for Service Guidance on Temporary Import of Clinically Urgent Drugs and Medical Devices. 《上海市关于临床急需药械临时进口服务指导工作方案（试行）》This new plan aims to streamline the temporary import process for clinically urgent drugs and medical devices in Shanghai, helping patients gain faster access to innovative medical products.