Obtaining import permits for medical devices in the Chinese market involves several key steps, primarily focusing on NMPA (National Medical Products Administration) certification and subsequent import procedures. Here’s a detailed guide:

1. Device Classification

• Determine the classification of the medical device (Class I, II, or III) according to the Chinese Medical Device Classification Catalogue, as this will dictate the regulatory requirements and approval process.

2. Pre-Market Preparation

• Technical Documentation: Prepare comprehensive technical documentation, including:
  • Device description, specifications, and intended use.
  • Compliance with relevant national and international standards (e.g., ISO, IEC).
  • Testing reports demonstrating safety and performance.

3. Quality Management System (QMS)

• Establish a QMS compliant with ISO 13485 or equivalent standards.
• Ensure documentation is available for audit, including procedures, records, and quality control measures.

4. NMPA Registration Application

• Submit Application: Prepare and submit the application for NMPA certification, which includes:
  • Application forms and relevant technical documents.
  • Clinical evaluation data if required, including clinical trial results.
  • Risk management file following ISO 14971.
• Review Process: After submission, the NMPA will review the application. They may request additional information or clarification during this phase.

5. Audits and Inspections

• Be prepared for potential audits or inspections by NMPA or designated third-party organizations to verify compliance with regulations and QMS.

6. Obtaining NMPA Certification

• Once the application is approved, the NMPA will issue the medical device registration certificate. This certification is essential for proceeding with import permits.

7. Import License Application

• Apply for an import license from the Ministry of Commerce (MOFCOM) or the local regulatory authority. Required documents may include:
  • NMPA registration certificate.
  • Business licenses of the importing company.
  • Import application forms.

8. Customs Clearance

• Prepare for customs procedures, which typically involve:
  • Submission of the import license and NMPA registration certificate.
  • Providing additional documents such as packing lists, invoices, and certificates of origin.
• Be aware of tariffs and taxes applicable to imported medical devices.

9. Post-Market Surveillance

• After obtaining import permits and launching the device in the market, establish a post-market surveillance plan to monitor the device’s performance and report any adverse events to NMPA.

10. Continuous Compliance

• Maintain compliance with ongoing regulatory requirements, including regular updates to NMPA and adherence to changes in regulations or standards.

Conclusion

Successfully navigating the NMPA certification and import procedures requires careful planning, thorough documentation, and compliance with regulatory standards. Engaging with local regulatory experts or consultants can help streamline the process and address any challenges that may arise.

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