Applying for NMPA (National Medical Products Administration) registration of medical devices in China involves several steps:

1. Pre-Submission Preparation

a. Classification:

• Determine the classification of your medical device (Class I, II, or III) to understand the regulatory requirements.

b. Product Testing:

• Conduct necessary product testing and obtain test reports from recognized laboratories, as required by NMPA.

c. Quality Management System (QMS):

• Ensure compliance with NMPA’s requirements for Good Manufacturing Practice (GMP) and have a QMS in place.

2. Document Preparation

a. Technical Documentation:

• Prepare comprehensive technical documentation, including device description, manufacturing processes, safety and effectiveness data, and clinical evaluation reports.

b. Registration Dossier:

• Compile the registration dossier which includes application forms, product information, testing reports, clinical data, and QMS documentation.

3. Appointment of an Authorized Representative

a. Local Representation:

• Appoint a local Authorized Representative (AR) in China who will act as your liaison with the NMPA.

4. Application Submission

a. Submit Application:

• Submit the completed application package to the NMPA through the online portal or local NMPA office.

b. Application Fee:

• Pay the required application fees as specified by the NMPA.

5. NMPA Review and Evaluation

a. Application Review:

• NMPA will review the submitted documents and may request additional information or clarifications.

b. On-Site Inspection:

• For certain devices, NMPA may conduct an on-site inspection of the manufacturing facility to verify compliance.

6. Approval and Certification

a. Registration Certificate:

• Upon successful evaluation, NMPA will issue a Registration Certificate for the medical device.

b. Post-Market Requirements:

• Adhere to post-market surveillance and reporting requirements as stipulated by NMPA, including adverse event reporting and periodic renewals.

7. Product Launch

a. Market Entry:

• Once registered, the device can be marketed and sold in China, following all applicable regulations and requirements.

8. Ongoing Compliance

a. Monitor Changes:

• Stay informed about regulatory changes and ensure continuous compliance with NMPA regulations, including renewals and updates to the registration.

By following these steps, you can navigate the NMPA registration process effectively and bring your medical device to the Chinese market.

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