The application process for NMPA (National Medical Products Administration) registration of Class I medical devices in China generally involves several key steps:

1. Classification Determination: Ensure your medical device is correctly classified as Class I according to NMPA guidelines. Class I devices are typically low-risk devices that are simpler in design and function.

2. Local Agent Requirement: You will need to appoint a local agent in China who will act as your representative throughout the registration process and after-sales service.

3. Technical Documentation Preparation: Gather and prepare comprehensive technical documentation, including:

   • Device description and specifications
   • Design drawings and diagrams
   • Manufacturing process details
   • Risk assessment documentation
   • Instructions for use (IFU)
   • Testing reports (if applicable)

4. Clinical Evaluation (if required): Some Class I devices may require clinical evaluation data to demonstrate safety and efficacy, especially if predicate devices are not available or if significant changes have been made.

5. Quality Management System (QMS): Implement a QMS (Quality Management System) compliant with relevant standards (e.g., ISO 13485) and provide evidence of compliance.

6. Submission of Application: Compile all required documents and submit the application to NMPA through your local agent. Ensure all forms are completed accurately and all necessary fees are paid.

7. Review and Approval: NMPA will review your application and may request additional information or clarifications. Once satisfied, they will issue a registration certificate allowing you to legally market your device in China.

8. Post-Market Surveillance: After obtaining registration, comply with post-market surveillance requirements, including reporting adverse events and maintaining vigilance over the device's performance.

Navigating these steps effectively requires thorough understanding of NMPA regulations and may benefit from assistance of local consultants or regulatory affairs experts familiar with the Chinese market and regulatory environment.

Contact Us：

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