The NMPA certification process for medical devices in China involves several key steps and operational details. Here’s a breakdown:

1. Pre-Application Preparation

• Determine Classification: Identify the medical device classification (Class I, II, or III) based on risk level.
• Quality Management System (QMS): Establish a compliant QMS, typically based on ISO 13485.

2. Document Compilation

• Technical Documentation: Prepare a complete technical file, including design, manufacturing processes, risk management, and clinical evaluation data.
• Product Testing Reports: Conduct necessary pre-market testing and compile results to demonstrate compliance with relevant standards.

3. Submission of Application

• Online Submission: Submit the application through the NMPA’s online platform, including all required documents and fees.
• Application Review: NMPA conducts a preliminary review to ensure all documents are complete.

4. Pre-Market Inspection

• On-Site Inspection: For Class II and III devices, NMPA may conduct an on-site inspection of the manufacturing facility to assess compliance with QMS and production practices.

5. Clinical Trials (if applicable)

• Approval for Trials: If clinical data is required, submit clinical trial applications to NMPA for approval before conducting trials.
• Conduct Trials: Execute the trials in compliance with Good Clinical Practice (GCP) guidelines.

6. Technical Review

• NMPA performs a detailed technical review of the submitted documents, focusing on safety, efficacy, and quality.

7. Approval and Registration

• If the review is successful, NMPA issues a medical device registration certificate.
• Devices are listed in the NMPA database, allowing for legal marketing in China.

8. Post-Market Obligations

• Post-Market Surveillance: Implement a post-market surveillance plan to monitor device performance and report adverse events.
• Renewal and Updates: Stay compliant with NMPA regulations, including timely renewal of certifications and updates for any changes in device design or use.

Conclusion

The NMPA certification process is comprehensive and requires careful preparation and adherence to regulatory requirements. Understanding each step and maintaining clear documentation are critical for successful certification. Engaging with local experts can facilitate compliance and streamline the process.

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