The application and approval process for NMPA certification of medical devices in China generally follows these stages:

1. Preparation Stage

• Device Classification: Determine the correct classification of your medical device according to NMPA regulations (Class I, II, III).

• Technical Documentation: Prepare detailed technical documentation including design information, manufacturing processes, materials used, and performance specifications.

• Quality Management System (QMS): Implement and document a QMS compliant with ISO 13485 or equivalent standards.

• Clinical Evaluation (if applicable): Conduct clinical evaluations and gather clinical data if required, particularly for higher-risk devices (Class II and III).

2. Application Submission

• Compile Application Dossier: Gather all necessary documents according to NMPA requirements, such as:

  • Technical files and design dossiers
  • Clinical evaluation reports
  • QMS documentation
  • Testing reports from accredited laboratories
  • Labeling and Instructions for Use (IFU) in Chinese
  • Manufacturing License (for foreign manufacturers)

• Submit Application: Submit the application dossier through the NMPA online registration system or via a local authorized agent in China.

3. Review and Evaluation

• Document Review: NMPA conducts a thorough review of the submitted documents to ensure they meet regulatory requirements and standards.

• Additional Information: They may request additional information or clarification during the review process.

4. Testing and Inspection

• Testing: Ensure the device complies with applicable Chinese national standards (GB standards) or international standards. Provide testing reports from accredited laboratories.

• On-Site Inspection (if applicable): For Class II and III devices, an on-site inspection of the manufacturing facilities may be required to verify compliance with QMS and production processes.

5. Approval Decision

• Approval Process: Once all requirements are satisfactorily met, NMPA will issue the Medical Device Registration Certificate (MDRC) indicating approval for market entry in China.

Key Considerations:

• Timelines: The certification process duration can vary depending on device complexity, classification, and completeness of the application. Delays may occur during document review or inspection phases.

• Local Representation: Having a local agent or representative in China can expedite communication with NMPA and facilitate compliance with local regulations.

• Regulatory Updates: Stay updated on any changes to NMPA regulations and guidelines to ensure ongoing compliance throughout the product lifecycle.

Navigating the NMPA certification process requires careful preparation, adherence to regulatory requirements, and possibly engaging with local experts to ensure a smooth application and approval process for your medical device in China.

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