NMPA Releases the 2025 Medical Device Industry Standards Revision Plan
The National Medical Products Administration (NMPA) has officially released the "2025 Medical Device Industry Standards Revision Plan," outlining the revision of 6 mandatory standards and 79 recommended standards. This initiative aims to enhance the safety, innovation, and international alignment of the medical device industry. The plan aligns with the "14th Five-Year National Drug Safety and High-Quality Development Plan" and promotes high-quality development of the medical device sector.
Key Highlights:
- Mandatory Standards: The plan includes 6 mandatory standards revision projects, covering critical areas such as manual resuscitators, thermal conduction therapy devices, balloon dilation catheters, holmium laser treatment devices, extracorporeal circulation tubing, and blood gas exchangers.
- Recommended Standards: The plan involves 79 recommended standards revision projects, focusing on cutting-edge fields such as AI-powered medical devices, nanomedicine, biomaterials, high-throughput sequencing technologies, dental equipment, and robotics.
- International Alignment: Some standards are aligned with ISO and other international standards to improve the global competitiveness of Chinese medical devices.
- Collaborative Efforts: The plan will be implemented through collaboration among regional regulatory authorities, technical committees, and research institutions to ensure scientific, reasonable, and applicable standards.
- Implementation Requirements: The NMPA has instructed provincial drug regulatory authorities and relevant technical committees to strictly follow the plan and complete tasks with high quality and efficiency. Broad research and technical validation are encouraged to ensure the standards meet scientific and policy requirements.
The release of this plan marks a significant milestone in the standardization of China's medical device industry, providing strong support for innovation and internationalization.