The application process for NMPA (National Medical Products Administration) registration of medical devices in China involves several detailed steps to ensure compliance with regulatory requirements. Here’s a structured outline of the application process:

Step-by-Step Application Process:

1. Preparation Phase:

   • Classification Determination: Determine the classification of your medical device according to the Chinese Medical Device Classification Catalog. This classification will determine the specific regulatory pathway and requirements for certification.

   • Technical Documentation Preparation: Compile comprehensive technical documentation required for the application. This includes:

     • Device description and specifications
     • Design drawings and diagrams
     • Risk analysis according to ISO 14971
     • Clinical evaluation reports (if applicable)
     • Biocompatibility testing reports according to ISO 10993
     • Electrical safety and electromagnetic compatibility (EMC) testing reports
     • Quality management system documentation (ISO 13485 compliance)
     • Labeling and Instructions for Use (IFU) in Chinese
     • Device master record (DMR) containing all necessary documents for device manufacture

2. Submission Phase:

   • Online Application: Submit the application through the China NMPA Online Registration System (CIRS).

   • Document Submission: Upload all required forms and documentation to the CIRS platform. Ensure that all information provided is complete, accurate, and complies with NMPA regulations.

   • Fee Payment: Pay applicable fees related to the certification process. Fees may vary based on the classification and type of medical device.

3. Review and Evaluation Phase:

   • Initial Review: NMPA conducts an initial review of the submitted documentation to assess compliance with Chinese regulatory standards. This includes evaluation of safety, efficacy, and quality requirements.

   • Technical Queries: NMPA may issue technical queries or requests for additional information during the review process. Promptly respond with comprehensive answers to expedite the review.

   • Testing and Evaluation: Verify that testing and evaluation reports align with Chinese standards. Ensure that testing is conducted in accredited laboratories and meets specified requirements.

4. On-site Inspection (if applicable):

   • Inspection Arrangement: For higher-risk devices, NMPA may schedule an on-site inspection of manufacturing facilities. This inspection evaluates adherence to quality management practices, production processes, and regulatory requirements.

   • Inspection Outcome: Address any findings or recommendations from the inspection to ensure compliance with NMPA standards.

5. Decision Phase:

   • Approval Decision: NMPA makes a decision on the application based on the outcome of the technical review, inspection (if applicable), and evaluation of submitted documentation.

   • Certificate Issuance: If the application meets all requirements and is approved, NMPA issues a registration certificate for the medical device. This certificate allows the device to be legally marketed and sold in China.

Important Considerations:

• Timeline: The entire process can take approximately 6 months to 1 year or longer, depending on the complexity of the device and any additional requirements encountered during the review and evaluation phases.

• Expert Assistance: Engaging with regulatory consultants or experts familiar with Chinese medical device regulations can help navigate the process effectively, ensuring compliance and timely approval.

• Post-Market Obligations: After certification, manufacturers must adhere to post-market surveillance requirements, report adverse events, and comply with ongoing regulatory obligations to maintain the NMPA registration.

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