NMPA Unveils Measures to Support High-End Medical Device Innovation with Full Lifecycle Regulation

China’s National Medical Products Administration (NMPA) last week released the “Measures to Optimize Full-lifecycle Regulation to Support High-End Medical Device Innovation”. This initiative aims to strengthen full-lifecycle supervision while fully supporting major innovations in the high-end medical device sector.

Regulatory Enhancements
The NMPA will continue to implement special innovation review procedures for domestically pioneered, globally leading high-end medical devices with significant clinical value. The agency is further optimizing the review process and enhancing communication between applicants and review experts. This includes providing stronger technical guidance for the R&D and registration of innovative medical devices. Changes to high-end innovative medical devices will be reviewed under the special innovation pathway.

Support for Market Entry and Innovation
The NMPA will support the accelerated market entry of high-end medical devices covered under national high-quality development action plans and other industrial policies. It will also strengthen registration guidance for AI and biomaterial projects under the “unveiling the list and competing for the best” initiative. Additionally, the NMPA will collaborate with relevant departments to introduce support policies for brain-computer interface (BCI)-based medical devices. For conditionally approved high-end medical devices, the NMPA will explore specific post-market requirements.

International Collaboration and Standards
The NMPA will actively engage in international standard-setting and accelerate the adoption of global standards. It will strengthen training on domestic regulatory standards and support the global expansion of high-end medical device companies by refining policies on export certification and expanding its scope. The agency will leverage international exchange platforms to track emerging trends in global medical device innovation and promote China’s regulatory framework and innovation achievements.-Fineline Info & Tech