Applying for NMPA (National Medical Products Administration) registration of medical devices in China involves meeting several key requirements. These requirements ensure that devices meet stringent safety, efficacy, and quality standards before they can be legally marketed and sold in the Chinese market. Here are the primary requirements:

1. Device Classification: Determine the correct classification of your medical device according to the NMPA's classification system (Classes I, II, or III). The classification determines the regulatory pathway and requirements for registration.

2. Quality Management System (QMS):

   • ISO 13485 Certification: Provide evidence of compliance with ISO 13485 or an equivalent quality management system standard. This certification demonstrates that your manufacturing processes meet international quality standards.

3. Technical Documentation:

   • Device Description: Detailed description of the device, including its intended use, specifications, and design rationale.
   • Technical Specifications: Clear and comprehensive specifications that describe the device's performance and functionality.
   • Testing Reports: Include results of performance testing, biocompatibility testing, electrical safety testing, and any other relevant tests conducted according to applicable standards.
   • Clinical Data: For Class II and III devices, provide clinical evaluation data demonstrating the device's safety and efficacy. This may include clinical trial data conducted in accordance with NMPA requirements.
   • Risk Management Documentation: Risk assessment and risk management plan that identifies and mitigates potential hazards associated with the device.

4. Labeling and Instructions for Use:

   • Ensure that labeling and instructions for use (IFU) are translated into Chinese.
   • Include clear labeling that complies with NMPA requirements regarding device identification, usage instructions, and safety information.

5. Manufacturing Information:

   • Provide details about your manufacturing processes and facilities, including evidence of compliance with Good Manufacturing Practice (GMP) standards or equivalent.

6. Clinical Trials (if applicable):

   • Conduct clinical trials in China for Class II and III devices, if required by the NMPA. Ensure these trials adhere to NMPA regulations and guidelines.

7. Local Agent or Representative:

   • If you are a foreign manufacturer, appoint a local agent or authorized representative in China. This representative will liaise with the NMPA on your behalf and handle regulatory communications.

8. Application Submission:

   • Submit your application and all required documentation through the NMPA's online platform or designated submission channels. Ensure that all documents are complete, accurate, and in compliance with NMPA regulations.

9. Technical Review and Evaluation:

   • The NMPA will review your application, technical documentation, and clinical data (if applicable). This includes a thorough evaluation to ensure that your device meets all regulatory requirements.

10. Quality System Inspection:

    • Prepare for potential on-site inspections of your manufacturing facilities by NMPA inspectors. Inspections verify compliance with quality system requirements and manufacturing standards.

11. Registration Certificate Issuance:

    • If your application is approved, the NMPA will issue a registration certificate. This certificate permits you to legally market and sell your medical device in China.

12. Post-Market Surveillance:

    • Comply with post-market surveillance requirements, including adverse event reporting and periodic reporting to the NMPA.

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