The license approval process for medical device registration in China, overseen by the National Medical Products Administration (NMPA), involves several systematic steps. This process ensures that medical devices meet safety, efficacy, and quality standards before they can be marketed. Here’s an in-depth overview of the steps typically involved:

1. Classification of Medical Devices

The first step is determining the classification of the medical device, which dictates the subsequent regulatory procedures:

• Classes: Medical devices in China are classified into three categories based on their risk level:
  • Class I: Low risk (e.g., bandages)
  • Class II: Moderate risk (e.g., diagnostic devices)
  • Class III: High risk (e.g., implants, life-supporting devices)

The classification will determine the type and extent of registration data required.

2. Preparation for Registration

Once the classification is established, the manufacturer should prepare the necessary documentation:

• Technical Files: Compile essential documentation, including device design and manufacturing information, risk assessment, quality control processes, labeling, and user manuals.
• Evidence of Safety and Efficacy: Gather preclinical (lab-based) and, if necessary, clinical data to demonstrate the safety and effectiveness of the device.

3. Local Agent

Foreign manufacturers must appoint a local Chinese agent (or representative) accredited to interact with the NMPA on their behalf. This representative assists in navigating regulatory requirements and can facilitate smoother communication with the NMPA.

4. Submission of Application

The next step involves preparing and submitting the application:

• Application Form: Complete the application form, which includes detailed information about the device, manufacturing process, and intended use.
• Documentation Submission: Submit the technical files, clinical trial data (if applicable), and the application form electronically through the NMPA's online submission system or directly to local NMPA offices.

5. Review Process

Upon submission, the NMPA will undertake several actions:

• Document Review: The NMPA reviews the submitted documents for completeness, accuracy, and adherence to regulatory requirements. This phase ranges from about 20 to 90 working days, depending on the class of the device.
• Supplemental Information Request: The NMPA may request additional information or clarification on the documentation during the review.

6. On-site Inspection

For Class II and III devices, an on-site inspection may be required:

• Facility Audit: NMPA officials may conduct audits of the manufacturing facilities to assess quality control procedures and compliance with Good Manufacturing Practices (GMP).
• Clinical Trials: If applicable, presentations of the trial site, protocols, and data may also be required.

7. Approval Decision

After reviewing all documentation and conducting inspections (if necessary):

• Issuance of Certificates: If approved, NMPA will issue a Registration Certificate that allows the device to be marketed in China. The timeline for this can typically range from a few months to over a year, depending on the complexity and classification of the device.

8. Post-market Obligations

Once a device has been approved, manufacturers must comply with ongoing regulatory obligations:

• Quality Assurance: Maintain compliance with the QMS and implement continuous quality management.
• Post-market Surveillance: Monitor the device’s performance in the market and report any adverse events or product issues to NMPA.
• Renewal and Updates: Registration is typically valid for five years; renewal requires submission of updated documents and possibly re-evaluation of the device.

9. Regulatory Changes Awareness

Manufacturers should stay informed about any changes in laws, regulations, or policies that may affect their registered products and overall compliance.

Conclusion

The NMPA license approval process for medical device registration in China is a multi-step procedure designed to ensure safety and efficacy. Understanding each stage and maintaining thorough documentation is crucial for a successful application. Engaging local regulatory experts can also ease the navigation through this complex process. If you have more specific questions or need further details on any part of the process, feel free to ask!

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