The process for NMPA (National Medical Products Administration) registration of Class III medical devices in China involves several key steps to ensure compliance with regulatory requirements. Here's a comprehensive outline of the process and steps involved:

1. Preparing for Registration

• Device Classification: Confirm the correct classification of your medical device according to the China Medical Device Classification Catalogue. Class III devices are typically high-risk devices that require stringent regulatory oversight.

• Regulatory Strategy: Determine the appropriate regulatory pathway based on your device classification and intended use. Understand the specific requirements and documentation needed for Class III devices.

2. Quality Management System (QMS) Compliance

• ISO 13485 Certification: Obtain ISO 13485 certification or an equivalent QMS certification recognized by the NMPA. This certification demonstrates that your manufacturing processes meet international standards for medical device quality management.

3. Technical Documentation Preparation

• Technical File Compilation: Prepare comprehensive technical documentation that demonstrates compliance with Chinese regulatory requirements. This includes:
  • Device description, specifications, and intended use.
  • Design and manufacturing information, including drawings and diagrams.
  • Risk analysis and mitigation strategies (according to ISO 14971).
  • Clinical evaluation data and performance testing reports.
  • Instructions for Use (IFU) and labeling information compliant with Chinese regulations.

4. Clinical Data (if applicable)

• Clinical Evaluation: Provide clinical evaluation reports or clinical trial data if required by the NMPA. This data should demonstrate the safety and efficacy of your device for its intended use in the Chinese market.

5. Local Representation

• Appoint a Local Agent: Designate a qualified local agent or representative in China who is registered with the NMPA. This agent will facilitate communication with regulatory authorities and handle submissions on your behalf.

6. Document Notarization and Translation

• Document Preparation: Ensure all documentation is notarized and translated into Chinese by qualified translators. Notarization verifies the authenticity of documents, while translation ensures compliance with local language requirements.

7. Submission and Review Process

• Application Submission: Compile and submit the registration application through the NMPA's designated online portal or physical submission process. Include all required documentation and pay the applicable fees.

• Technical Review: The NMPA will conduct a technical review of your submission to assess compliance with regulatory requirements. They may request additional information or clarification during this process.

8. On-Site Inspection (if applicable)

• Inspection Request: Depending on the device type and risk classification, the NMPA may request an on-site inspection of your manufacturing facilities to verify compliance with Good Manufacturing Practices (GMP).

9. Registration Decision

• Approval: Upon successful review and inspection (if applicable), the NMPA will issue a registration certificate indicating approval for your Class III medical device to be marketed in China.

10. Post-Approval Responsibilities

• Post-Market Surveillance: Establish procedures for monitoring and reporting adverse events related to your device. Comply with ongoing vigilance and reporting requirements as specified by the NMPA.

• Annual Reporting: Submit annual reports to the NMPA detailing device sales, adverse events, and updates on post-market surveillance activities.

11. Renewal and Updates

• Renewal: Monitor the expiration date of your registration certificate and initiate the renewal process in advance to maintain market authorization in China.

• Updates: Notify the NMPA of any significant changes to device design, manufacturing processes, or labeling. Obtain approval for these changes before implementing them in the market.

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