Registering medical devices in China involves several key steps, primarily overseen by the National Medical Products Administration (NMPA). Here’s an overview of the registration procedures:

1. Determine Device Classification

• Medical devices in China are classified into three categories:
  • Class I: Low-risk devices requiring only record-filing.
  • Class II: Moderate-risk devices requiring NMPA registration.
  • Class III: High-risk devices requiring a more rigorous review process.

2. Pre-Market Approval

• For Class II and III devices, manufacturers must submit a pre-market approval application, which includes:
  • Application form.
  • Device description and specifications.
  • Clinical evaluation report (for Class II and III).
  • Testing reports (safety and efficacy) from accredited laboratories.
  • Quality management system documentation (ISO 13485 or equivalent).

3. Clinical Trials

• For Class III devices, clinical trials may be required unless exempted. Trials must be conducted according to Good Clinical Practice (GCP) guidelines and must be approved by the NMPA.

4. Submission of Application

• Submit the application package through the NMPA’s online system. Ensure that all documents are in Chinese and meet specific formatting requirements.

5. Technical Review

• NMPA conducts a technical review of the submitted documents. This can take several months. Additional information may be requested during this phase.

6. Approval and Issuance of Registration Certificate

• If the application is approved, the NMPA issues a medical device registration certificate. The validity of the certificate is typically five years, after which renewal is required.

7. Post-Market Surveillance

• After obtaining approval, manufacturers must comply with post-market surveillance regulations, including adverse event reporting and product recalls if necessary.

8. Renewal and Changes

• For Class II and III devices, renewal of the registration is required every five years. Any significant changes in the device (e.g., design, manufacturing process) must be reported to the NMPA.

Additional Considerations

• Local Agent Requirement: Foreign manufacturers must appoint a local agent in China to facilitate the registration process.
• Documentation Language: All submitted documentation must be in Chinese, and careful attention should be paid to translation accuracy.

Useful Resources

• NMPA Website: For the latest regulations and guidance, refer to the official NMPA website.

Navigating the NMPA registration process can be complex, and it may be beneficial to engage a local regulatory consultant to assist with the application and ensure compliance with all requirements.

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