By Fineline Cube 
The National Medical Products Administration (NMPA) has released the “Measures for Optimizing Full Lifecycle Supervision to Support the Innovative Development of High-end Medical Devices (Draft Proposal)” and is soliciting public feedback until April 15, 2025. This initiative aims to streamline regulatory processes and foster innovation in the high-end medical device sector.
Regulatory Enhancements
The draft proposal highlights several key areas for optimization:
- Special Approval Procedures: Streamlined approval processes for high-end medical devices.
- AI and Biomaterials Guidance: Strengthened regulatory filing guidance for AI-based products and biomaterials.
- Brain-Computer Interface Technology: Introduction of support policies for medical device products based on brain-computer interface technology.
- Conditional Approval Requirements: Exploration of specific requirements for conditional approval to accelerate market entry for innovative products.
Classification and Naming Rules
The document pledges to improve classification and naming rules, develop guidelines for medical robots (including surgical and rehabilitation robots), and conduct research on the management attributes and categories of various products such as medical large-scale models, AI medical devices, synthetic biomaterials, tissue engineering products, and medical imaging reconstruction software.
Standard System Improvement
Efforts will focus on:
- Enhancing the standard system and clarifying registration review requirements.
- Improving standards and review systems for medical robots, radionuclide imaging equipment, AI medical devices, high-end medical imaging equipment, medical materials, brain-computer interfaces, and other products.
- Establishing communication, guidance, and expert consultation mechanisms to support the testing, clinical evaluation, and registration of high-end medical device products.
Post-Market Regulation
Post-market regulatory requirements will be refined with enhanced quality monitoring. Government departments will closely monitor industry developments, regularly publish approved high-end medical device product lists, and establish regular communication mechanisms to address issues promptly. The proposal also emphasizes promoting regulatory science, leveraging real-world evidence for decision-making, and engaging in international regulatory cooperation through forums like the IMDRF and GHWP, as well as with regulatory agencies in Belt and Road Initiative countries.-Fineline Info & Tech