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Policy Analysis and Guidance: Xinjiang’s Priority Registration for Medical Device Applications

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

Policy Analysis and Guidance: China’s Medical Device Regulation and Innovation Push

On March 29, 2025, Xu Jinghe, Vice Minister of China’s National Medical Products Administration (NMPA), conducted a field research in Qingdao, visiting medical device companies and a hospital to understand the innovation and quality supervision of the medical device industry. Xu emphasized the importance of implementing the “four strictest” requirements, strengthening the quality responsibility system, and promoting innovation in the medical device sector.

Key Policy Highlights

Quality and Safety Supervision
- Stringent Requirements: Adherence to the “four strictest” principles to ensure the safety and quality of medical devices.
- Lifecycle Regulation: Enhancing supervision across the entire lifecycle of medical devices, from production to distribution and usage.
Enterprise Responsibility
- Accountability: Medical device manufacturers are the primary responsible parties for product quality and safety.
- Compliance: Ensuring enterprises strictly comply with regulatory standards and maintain quality management systems.
Support for Innovation
- Mechanism Improvement: Establishing and improving mechanisms to support the development of innovative medical devices.
- Regulatory Capacity: Strengthening the regulatory system and capacity building to facilitate research, development, and innovation in the medical device industry.
Industry Development
- High-Quality Growth: Promoting high-quality development of the medical device industry through policy support and regulatory optimization.

Policy Orientation and Industry Implications
Xu’s research and remarks highlight the Chinese government’s strategic focus on:

Safety Assurance: Prioritizing the safety and quality of medical devices through rigorous regulatory measures.
Innovation Drive: Encouraging innovation to enhance the competitiveness and technological level of the medical device industry.
Industry Support: Creating a favorable policy environment to support the sustainable and high-quality development of the sector.

Conclusion
China’s enhanced focus on medical device regulation and innovation reflects its commitment to improving public health outcomes and fostering a robust medical device industry. Companies in the sector should align with these policy directions to ensure compliance while leveraging innovation to gain a competitive edge in the market.-China Health Reform Pulse

Policy Source: https://www.nmpa.gov.cn/yaowen/ypjgyw/ylqxyw/20250330085803195.html

Policy Analysis and Guidance: Jiangsu Province’s Medical Device Quality and Safety Assessment Measures

Jiangsu Provincial Drug Administration has issued new measures for assessing the quality and safety responsibilities of medical device manufacturers. The “Jiangsu Province Medical Device Production Enterprises Quality and Safety Main Responsibility Assessment Measures” aim to strengthen enterprises’ responsibility for quality and safety, enhance regulatory precision, and promote the high-quality development of the medical device industry.

Key Policy Measures

Annual Assessment System
- Frequency: Enterprises are assessed annually based on their performance in fulfilling quality and safety responsibilities.
- Scope: The assessment covers the period from January 1 to December 31 of the previous year. New enterprises and those that have been out of production for over a year are excluded.
Three-Tier Grading System
- Grades: Enterprises are classified into three levels: A (excellent), B (good), and C (average).
- Criteria:
  – A Grade: Score of 90 or above.
  – B Grade: Score between 75 and 89.
  – C Grade: Score below 75.
Immediate Downgrade Mechanism
- Circumstances: Enterprises found with serious violations, product quality issues leading to severe incidents, or failure to recall defective products will be immediately downgraded to C.
Self-Assessment and Reporting
- Process: Enterprises must complete self-assessment by March 31 each year and submit reports to the provincial drug administration’s regulatory platform.
Regulatory Review and On-Site Inspection
- Procedure: Local market supervision bureaus and inspection branches will review self-assessment reports and conduct on-site inspections on no less than 3% of enterprises by May 31.
Incentive and Constraint Mechanisms
- Measures: Enterprises of different grades will face corresponding incentives or constraints to encourage continuous improvement in quality and safety management.

Policy Orientation and Industry Implications
The new assessment measures highlight Jiangsu’s strategic focus on:

Quality and Safety: Prioritizing product reliability and consumer protection.
Regulatory Precision: Enhancing the scientific and precise nature of industry oversight.
Industry Upgrading: Driving the medical device sector toward higher quality and innovation.-China Health Reform Pulse

Policy Source: http://da.jiangsu.gov.cn/art/2025/3/28/art_84620_11527826.html