To apply for Class II Medical Device NMPA registration in China, you need to follow a structured process and submit your application through the appropriate channels. Here’s a step-by-step guide on how and where to apply:

Steps to Apply for NMPA Registration:

1. Preparation Phase:

   • Device Classification: Confirm that your medical device is classified as Class II according to Chinese regulatory standards.
   • Compile Technical Documentation: Gather all required documents, including device description, design specifications, risk analysis, clinical evaluation data (if applicable), test reports, labeling, instructions for use (IFU), and quality management system documentation.

2. Appointment of Local Agent:

   • As a foreign manufacturer, appoint a qualified local agent in China who will act as your official representative throughout the registration process. The local agent must have a registered office in China and be familiar with Chinese medical device regulations.

3. Testing and Certifications:

   • Conduct necessary testing according to Chinese national standards (GB standards) or internationally recognized standards. Obtain test reports from accredited laboratories demonstrating compliance with safety, performance, and biocompatibility requirements.

4. Application Submission:

   • Submit your registration application through the China Medical Device Registration (CMDR) system. This online platform is managed by the National Medical Products Administration (NMPA) of China.
   • Your local agent will typically handle the submission process through the CMDR system on your behalf. Ensure all required documents are accurately uploaded according to system guidelines.

5. Review and Evaluation:

   • NMPA will review your application and technical documentation to assess compliance with regulatory requirements. This may involve a thorough evaluation of submitted documents and, in some cases, requests for additional information or clarifications.

6. Onsite Inspection (if required):

   • Depending on the device classification and risk assessment, NMPA may conduct an onsite inspection of your manufacturing facilities or engage a third-party organization to verify compliance with Good Manufacturing Practice (GMP) standards.

7. Approval and Registration:

   • Upon successful review and any required inspections, NMPA will issue a registration certificate for your Class II medical device. This certificate allows your device to be legally marketed and distributed in China.

Where to Apply:

• China Medical Device Registration (CMDR) System: This is the official online platform managed by NMPA for submitting medical device registration applications. Your local agent will access and navigate the CMDR system to submit your application electronically.

Considerations:

• Regulatory Expertise: Engage with regulatory consultants or legal experts who specialize in Chinese medical device regulations to ensure compliance and navigate the registration process efficiently.
• Timelines: Plan for a potentially lengthy process, typically ranging from 12 to 18 months or more, depending on the complexity of the device and regulatory requirements.
• Costs: Budget for expenses related to document preparation, testing and certification, consultancy fees, and potential onsite inspections.

Contact Us：

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