By Fineline Cube 
China’s National Medical Products Administration (NMPA) has released its 2025 medical device inspection plan, outlining stricter quality oversight and compliance requirements. The new guidelines aim to enhance product safety, enforce regulatory standards, and streamline market access for domestic and international manufacturers.
Key Policy Highlights
- Comprehensive Inspection Requirements: Provincial drug administration bureaus and the China Institute of Food and Drug Control (CIFDC) must adhere to mandatory standards and registered technical requirements for medical devices.
- Deficiency Management: Inspection institutions are required to document cases where full testing cannot be completed due to incomplete technical requirements or insufficient documentation. Non-compliance will be recorded in enterprise credit archives, triggering enhanced supervision.
- Credit Archiving: Enterprises failing to cooperate with inspections will face stricter oversight, including increased inspection frequency and public credit record updates.
Impact on Medical Device Manufacturers
- Technical Compliance: Manufacturers must ensure product technical requirements align with mandatory standards to avoid inspection failures.
- Documentation Rigor: Comprehensive submission of technical documentation and supporting materials is critical to avoid delays in certification.
- Credit System Alignment: Non-cooperation or repeated deficiencies will directly impact corporate credit ratings, affecting market access and regulatory trust.
Reinspection Process
- Single Reinspection Rule: Only one reinspection per report is permitted, managed by provincial drug administration departments.
- Institution Accountability: Reinspection institutions must maintain technical capability and transparency, with obligations to support provincial enforcement activities.
- Risk Monitoring Exemptions: Products flagged for risk monitoring are excluded from reinspection eligibility.
Market Implications
The policy reinforces China’s commitment to quality and compliance, creating a more transparent and competitive market. Manufacturers prioritizing technical standards and creditworthiness are likely to gain regulatory favor and market trust.
Conclusion
China’s 2025 medical device inspection plan underscores its dual mandate of safety and compliance. Global and domestic players must adapt to these standards to ensure market sustainability and avoid regulatory hurdles.-Fineline Info & Tech