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

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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