The General Office of the State Council issued the “Opinions on Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry” on January 3, 2025. It calls for comprehensive regulatory reform and the promotion of high-quality development in the healthcare sector at the national level. For overseas medical device manufacturers, the following benefits are highlighted:
Focus on Clinically Urgent Devices
Section 2.1 of the Opinions emphasizes the principles of “early involvement, tailored strategies, comprehensive guidance, and coordinated research and review.” Regulatory resources will prioritize innovative drugs and medical devices that are urgently needed in clinical settings. The process includes enhanced communication and personalized guidance throughout clinical trials, registration, inspections, and approvals.
Measures include:
- Accelerating approval for clinically urgent products and rare disease treatments.
- Continuing to explore allowing specific medical institutions to import unregistered drugs and medical devices for clinical use.
- Encouraging high-level medical institutions to develop and use diagnostic reagents for rare diseases that are not yet available domestically.
Priority Approval for High-End Devices
High-end medical equipment such as surgical robots, brain-computer interface devices, radiation therapy equipment, and advanced imaging devices will be given priority in the review and approval process.
Priority Testing for Innovative Medical Devices
A green channel for priority testing of innovative medical devices will be established, enabling immediate testing for clinically urgent devices upon submission. Efficiency in supervising and inspecting medical devices will be improved, including combined inspections for manufacturers producing both Class II and Class III devices.
Alignment with International Standards
The Opinions outline steps to:
- Deepen the implementation of the National Medical Device Standards Improvement Action Plan, optimizing the standard system for medical devices.
- Establish standardization organizations for frontier technologies such as artificial intelligence and medical robots.
- Advance the adoption of international regulatory frameworks like IMDRF and GHWP, benchmarking against global best practices to optimize approval processes for imported products.
China has already issued over 2,000 national and industry standards for medical devices. In 2024, two industry standards related to brain-computer interface technology were approved under an expedited process. Standards in areas such as medical software and surgical robots have significantly driven the development of relevant industries.
Facilitating Transition to Domestic Production
The review and approval processes for transitioning production from overseas to domestic facilities will be optimized. Foreign-invested enterprises are encouraged to manufacture original drugs and high-end medical equipment within China.
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