For NMPA Class III medical devices, which are high-risk devices, the registration application requirements include:

1. Completed Application Form: Fill out the NMPA registration form accurately.

2. Manufacturer’s Documentation:

   • Business license.
   • Manufacturing license.
   • Quality Management System (QMS) certification (ISO 13485 or equivalent).

3. Device Information:

   • Detailed description and intended use.
   • Technical specifications.
   • Labeling and packaging information.

4. Clinical Data:

   • Comprehensive clinical trial data or evaluation reports demonstrating the safety and efficacy of the device. This often involves significant clinical studies.

5. Testing Reports:

   • Reports from accredited laboratories proving compliance with Chinese standards (e.g., GB standards).

6. Pre-Market Approval: For some Class III devices, you may need to obtain pre-market approval from specific national or regional authorities before NMPA registration.

7. Factory Inspection:

   • NMPA may conduct a factory inspection to verify the manufacturing processes and quality control.

8. Local Representation:

   • Foreign manufacturers must have a local representative in China to manage regulatory affairs.

9. Additional Documentation:

   • Any other documents or certificates required by NMPA specific to the device category.

Application Process:

• Submit Online: Register and submit documents via the NMPA’s online platform.
• Physical Submission: Provide hard copies to the NMPA office as required.

Approval:

• Review: NMPA reviews the application, which may involve requests for additional information.
• Certification: Upon approval, receive the NMPA Registration Certificate.

Ensure compliance with NMPA regulations and guidelines for a successful application.

Contact Us：

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