The review cycle and implementation rules for NMPA (National Medical Products Administration) certification applications in China involve several stages and specific guidelines to ensure thorough evaluation and compliance with regulatory requirements. Here’s an overview of the review cycle and key implementation rules:

Review Cycle:

1. Submission and Validation:

   • Application Submission: Submit the application for NMPA certification through the China NMPA Online Registration System (CIRS).
   • Document Validation: NMPA will validate the submitted documentation to ensure completeness and accuracy. This includes verifying that all required forms, technical documentation, test reports, and fees are included.

2. Technical Review:

   • Initial Review: NMPA initiates a technical review process to evaluate the submitted documentation. This review assesses compliance with Chinese regulatory standards, including safety, performance, and quality requirements.
   • Technical Queries: NMPA may issue technical queries or requests for additional information during the review process. Responding promptly and comprehensively to these queries is crucial to avoid delays.

3. Testing and Evaluation:

   • Testing Verification: Verify that the conducted testing and evaluations align with Chinese standards and regulations. Ensure all testing is performed in accredited laboratories and meets the specified requirements.

4. On-site Inspection (if applicable):

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

5. Review Committee (if applicable):

   • Convene Review Committee: Certain high-risk devices may require the convening of a review committee to provide expert evaluation and recommendations to NMPA.
   • Committee Evaluation: The committee assesses the technical documentation, testing results, and inspection findings to ensure thorough review and compliance with regulatory standards.

6. Decision Making:

   • Approval Decision: NMPA makes a decision on the application based on the outcome of the technical review, inspection (if applicable), and committee evaluation (if convened).
   • Certificate Issuance: If the application meets all requirements and is approved, NMPA issues a registration certificate for the medical device, allowing it to be marketed and sold in China.

Implementation Rules:

1. Compliance with Chinese Standards: Ensure that all aspects of the application, including technical documentation, testing, and manufacturing processes, comply with relevant Chinese national standards and regulations for medical devices.

2. Quality Management System (QMS):

   • Implement and maintain a robust quality management system (QMS) that complies with ISO 13485 or an equivalent standard.
   • Demonstrate effective implementation of QMS practices, including design controls, production processes, risk management, and post-market surveillance.

3. Clinical Data (if applicable):

   • Provide clinical data and evidence to demonstrate the safety and efficacy of the medical device, particularly for higher-risk classifications.
   • Ensure that clinical studies and evaluations meet NMPA’s requirements and standards.

4. Labeling and Instructions for Use (IFU):

   • Prepare device labeling and IFU in compliance with NMPA regulations, including requirements for Chinese language labeling.
   • Ensure that labeling provides clear and accurate information for safe and effective use of the device by healthcare professionals and end-users in China.

5. Post-Market Surveillance:

   • Implement post-market surveillance activities to monitor device performance, collect user feedback, and report adverse events as required by NMPA.
   • Maintain records and documentation of post-market surveillance activities for regulatory compliance and reporting purposes.

6. Authorized Representative (AR):

   • For foreign manufacturers, appoint an Authorized Representative (AR) in China who takes responsibility for regulatory compliance and acts as a liaison with NMPA.

Understanding and adhering to these review cycle and implementation rules is essential for navigating the NMPA certification process effectively. Engaging with regulatory experts or consultants familiar with Chinese medical device regulations can help streamline the process and ensure compliance with regulatory requirements.

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