To apply for NMPA (National Medical Products Administration) registration of Class III medical devices in China, several conditions must be met to ensure compliance with Chinese regulatory requirements. Here are the key conditions:

1. Correct Device Classification: Verify that your medical device is classified correctly as Class III according to Chinese regulatory standards. Class III devices typically include high-risk devices such as implantable devices and life-supporting equipment.

2. Technical Documentation: Prepare comprehensive technical documentation that includes:

   • Device description and specifications.
   • Design drawings and diagrams.
   • Manufacturing processes and quality control procedures.
   • Risk analysis and mitigation strategies.
   • Instructions for use and labeling information.

3. Quality Management System Certification: Obtain ISO 13485 certification or an equivalent quality management system certification recognized by the NMPA. This certification demonstrates that your manufacturing processes and quality systems meet international standards.

4. Clinical Data (if applicable): Provide clinical evaluation data or clinical trial reports to demonstrate the safety and efficacy of your device. This may include clinical trials conducted in China or data from other countries that meet Chinese regulatory requirements.

5. Local Testing (if required): Some Class III devices may require testing in China to demonstrate compliance with Chinese standards and regulations. Testing should be conducted at accredited Chinese laboratories.

6. Appointment of a Local Agent: Designate a local agent or representative in China who is registered with the NMPA. This agent will handle communication with regulatory authorities on your behalf and facilitate the application process.

7. Application Submission: Submit your application and all required documents through the NMPA’s designated online submission portal or physically to the NMPA office, ensuring all documents are translated into Chinese and comply with regulatory requirements.

8. Regulatory Compliance: Ensure that your device and documentation comply with all relevant Chinese regulatory standards, including safety, efficacy, and quality requirements.

9. On-site Inspection (if applicable): Be prepared for a potential on-site inspection of your manufacturing facilities by the NMPA to verify compliance with quality standards and regulatory requirements.

10. Post-Market Surveillance: Commit to post-market surveillance requirements, including monitoring device performance, reporting adverse events, and maintaining ongoing compliance with regulatory standards after obtaining registration.

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