The application procedure for NMPA (National Medical Products Administration) certification of medical devices in China involves several steps and requires careful adherence to regulatory requirements. Here’s an outline of the general procedure and key requirements:

Application Procedure:

1. Classification Determination: Determine the correct classification of your medical device according to the NMPA guidelines. This classification will determine the specific requirements and approval pathway.

2. Quality Management System (QMS) Compliance: Implement a Quality Management System that meets the requirements of ISO 13485 or other applicable standards. The QMS ensures that your manufacturing processes consistently produce medical devices that meet regulatory standards.

3. Technical Documentation Preparation: Compile comprehensive technical documentation, including:

   • Device description and specifications
   • Design and manufacturing information
   • Risk assessment
   • Clinical evaluation data (if required)
   • Labeling and packaging information
   • Instructions for use
   • Testing reports (e.g., safety, performance, EMC)
   • Verification and validation documentation

4. Testing and Evaluation: Conduct necessary testing and evaluations to demonstrate compliance with Chinese regulatory requirements. This includes safety, performance, and EMC testing at accredited laboratories recognized by NMPA.

5. Manufacturing Site Audit: Prepare for and undergo an audit of your manufacturing facilities to ensure compliance with Good Manufacturing Practice (GMP) requirements specified by NMPA.

6. Application Submission: Submit your application to NMPA through the appropriate channels, typically using the NMPA’s online submission platform. Include all required documentation, test reports, and audit results.

7. Review and Approval: NMPA will review your application, technical documentation, and testing reports to assess whether your medical device meets safety, efficacy, and quality requirements. The review process may involve several rounds of evaluation and clarification requests.

8. Post-Market Surveillance Plan: Develop and submit a post-market surveillance plan outlining how you will monitor the safety and performance of your device after it enters the market.

9. Registration Certificate Issuance: Upon successful review and approval, NMPA will issue a registration certificate for your medical device. This certificate allows you to legally market and sell your device in China.

Key Requirements:

• Legal Manufacturer: The application must be submitted by the legal manufacturer of the medical device or an authorized representative.

• Local Agent: For foreign manufacturers, appoint a local agent or representative in China who can facilitate communication with NMPA and other local authorities.

• Clinical Evaluation: Depending on the device classification and risk level, clinical evaluation data may be required to demonstrate safety and efficacy.

• Labeling and Instructions for Use: Ensure that labeling and instructions for use are provided in Chinese and comply with Chinese regulatory requirements.

• Adverse Event Reporting: Establish procedures for reporting adverse events or incidents related to your device to NMPA as per regulatory guidelines.

Navigating the NMPA certification process requires meticulous preparation, compliance with standards, and thorough documentation. Engaging with experienced regulatory consultants or local experts in China can help streamline the process and ensure successful certification of your medical device.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn