Xinjiang’s Drug Evaluation and Inspection Center has released a notice on the priority registration application review results for medical devices (2025 No. 1). This initiative aims to expedite the registration process for specific medical devices, reflecting the region’s commitment to supporting innovation and addressing public health needs.
Key Policy Highlights
- Priority Registration Criteria
- Basis: Applications are reviewed under the “Xinjiang Uygur Autonomous Region Second-Class Medical Device Special Registration Procedure” (Announcement No. 39, 2021).
- Purpose: To accelerate the registration of devices that meet specific priority criteria.
- Publicize Details
- Period: The public announcement period is from March 24 to 28, 2025.
- Content: Lists the product “Electronic Gastroscopy” by Xinjiang Ruijiang Biotechnology Co., Ltd., which qualifies for priority registration due to meeting specific criteria.
- Objection Process
- Contact: Stakeholders with objections are encouraged to contact the center within the announcement period.
Policy Orientation and Industry Implications
The priority registration policy reflects Xinjiang’s strategic focus on:
- Innovation Support: Accelerating the market entry of innovative medical devices.
- Public Health: Addressing urgent public health needs through faster access to critical devices.
- Regulatory Efficiency: Streamlining the registration process to support industry development.
Conclusion
Xinjiang’s priority registration initiative for medical devices sets a precedent for regional regulatory support, emphasizing innovation and public health. Companies in the medical device sector should leverage this policy to expedite product development and market entry.-China Health Reform Pulse
Policy Source: http://mpa.xinjiang.gov.cn/xjyjj/ylqxggtg/202503/b44f72f43777439793f7df0b2bb3673d.shtml