Registering Class III medical devices with the NMPA (National Medical Products Administration) in China involves a detailed and rigorous process. Here’s a comprehensive guide:

1. Pre-Registration Preparation

1.1 Determine Device Classification

• Ensure the device is correctly classified as Class III based on its risk level and intended use.

1.2 Assemble a Regulatory Team

• Engage with local regulatory consultants or agents who are familiar with NMPA procedures.

2. Documentation and Application Preparation

2.1 Application Form

• Complete the NMPA application form for Class III medical devices.

2.2 Product Description

• Detailed description of the device, including intended use, design, components, and technology.

2.3 Technical Documentation

• Design and Manufacturing Information: Include design specifications, manufacturing processes, and risk management documents.
• Clinical Data: Provide clinical trial data demonstrating safety and effectiveness. This data should ideally come from studies conducted in China or other comparable studies if available.
• Quality Management System (QMS) Certification: Proof of QMS compliance (e.g., ISO 13485).
• Product Testing Reports: Reports from accredited laboratories showing the device meets relevant Chinese standards for performance, safety, and biocompatibility.

2.4 Labeling and Instructions

• Translations of labeling, instructions for use, and other user information into Chinese.

2.5 Manufacturing Information

• Documentation on the manufacturing facility’s compliance with Good Manufacturing Practices (GMP) and other relevant standards.

3. Submission to NMPA

3.1 Online Submission

• Submit the application and all supporting documents through the NMPA’s online submission system.

3.2 Physical Submission

• Submit physical copies of documents to the NMPA office if required.

4. Review and Evaluation

4.1 Initial Review

• NMPA will review the submission for completeness and adherence to requirements.

4.2 Technical Review

• Detailed review of technical documentation, clinical data, and testing results.

4.3 On-site Inspection

• NMPA may conduct an on-site inspection of the manufacturing facility to verify compliance with GMP and other standards.

4.4 Clinical Trial Review

• The clinical trial data will be thoroughly evaluated. Additional clinical trials in China may be required if there is insufficient data.

5. Fees

5.1 Application Fee

• Pay the application fee, which varies depending on the device type and registration process.

5.2 Review Fee

• Additional fee for the review process.

5.3 Testing Fees

• Fees associated with required testing and inspections.

6. Approval and Issuance

6.1 Approval Notification

• After successful review and inspections, receive an approval notification from the NMPA.

6.2 Issuance of Certificate

• NMPA will issue the registration certificate for the Class III medical device.

7. Post-Approval Requirements

7.1 Regulatory Compliance

• Ensure continuous compliance with Chinese regulations and standards.

7.2 Reporting Obligations

• Report any adverse events or issues related to the device to the NMPA.

7.3 Renewal and Updates

• Periodically renew the registration certificate and submit applications for any significant changes or updates to the device.

8. Additional Considerations

8.1 Local Representation

• Consider engaging with a local agent or consultant to navigate the registration process effectively.

8.2 Translation

• Ensure that all documents are accurately translated into Chinese.

8.3 Regulatory Changes

• Stay informed about changes in NMPA regulations and guidelines to ensure ongoing compliance.

If you have specific questions or need further details, feel free to ask!

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