The license application process for China NMPA certification involves several key steps. Here’s a concise overview:

1. Preliminary Assessment

Conduct an initial assessment to determine if the device requires NMPA registration and identify the appropriate classification (Class I, II, or III).

2. Document Preparation

Gather necessary documents, including:

• Product specifications
• Clinical data (if applicable)
• Quality management system documentation (ISO 13485)
• Safety and efficacy testing reports

3. Clinical Trials (if required)

For Class II and III devices, conduct clinical trials in compliance with NMPA regulations. This may involve obtaining a clinical trial approval letter.

4. Application Submission

Submit the application package, including all required documents, to the NMPA via the China Drug Regulatory System (CDR).

5. Acceptance Review

NMPA conducts an acceptance review to ensure the application is complete. If any documents are missing, they will request additional information.

6. Technical Review

The NMPA evaluates the technical aspects of the application, including safety, efficacy, and quality. This may involve consultation with expert reviewers.

7. Inspection (if applicable)

For certain devices, the NMPA may require an on-site inspection of the manufacturing facility to ensure compliance with quality standards.

8. Approval and License Issuance

If the application meets all requirements, the NMPA issues a Medical Device Registration Certificate, allowing the product to be marketed in China.

9. Post-Market Surveillance

After obtaining certification, manufacturers must adhere to post-market surveillance requirements, reporting any adverse events or product issues to the NMPA.

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