The process of NMPA (National Medical Products Administration) registration for medical devices in China involves several steps, requires specific documents, and entails various considerations to ensure compliance with regulatory requirements. Here's a comprehensive guide:

Process:

1. Device Classification:

   • Determine the classification of your medical device according to NMPA regulations (Classes I, II, or III). This classification determines the regulatory pathway and requirements for registration.

2. Local Agent or Representative:

   • If you are a foreign manufacturer, appoint a local agent or authorized representative in China. This representative will communicate with the NMPA on your behalf and handle regulatory submissions.

3. Documentation Preparation:

   • Technical Documentation: Prepare detailed technical documentation, including:
     • Device description, specifications, and intended use.
     • Technical specifications and design rationale.
     • Testing reports (e.g., performance testing, biocompatibility testing).
     • Risk assessment and management plan.
     • Quality Management System (QMS) documentation, such as ISO 13485 certification or equivalent.
   • Clinical Data: Provide clinical evaluation data, especially for Class II and III devices. This may include clinical trial reports conducted in accordance with NMPA requirements.
   • Labeling and Instructions for Use: Ensure labeling and IFU (Instructions for Use) are translated into Chinese.
   • Manufacturing Information: Details about manufacturing processes and facilities, including compliance with Good Manufacturing Practice (GMP).

4. Clinical Trials (if applicable):

   • Conduct clinical trials in China, if required by the NMPA for Class II and III devices. Ensure trials adhere to NMPA guidelines and are conducted ethically and with regulatory compliance.

5. Application Submission:

   • Submit your application and all required documentation through the NMPA's online platform or designated submission channels. Ensure all documents are complete, accurate, and translated into Chinese where necessary.

6. Technical Review and Evaluation:

   • The NMPA will conduct a technical review of your application, including:
     • Technical documentation review to assess compliance with NMPA standards.
     • Clinical evaluation review to evaluate safety and efficacy data.
     • Quality system inspection, which may include an on-site audit of manufacturing facilities.

7. Registration Certificate Issuance:

   • Upon successful review, the NMPA will issue a registration certificate. This certificate allows you to legally market and sell your medical device in China.

8. Post-Market Surveillance:

   • Comply with post-market surveillance requirements, including adverse event reporting, product monitoring, and periodic reporting to the NMPA.

Required Documents:

• Device Classification Confirmation
• Technical Documentation (device description, specifications, testing reports, risk assessment)
• Quality Management System (QMS) Documentation (ISO 13485 certification or equivalent)
• Clinical Data and Evaluation (including clinical trial reports if applicable)
• Labeling and Instructions for Use (translated into Chinese)
• Manufacturing Information (facility details, GMP compliance)

Considerations:

• Regulatory Updates: Stay informed about changes in NMPA regulations and guidelines throughout the registration process.
• Local Representation: Ensure your local agent or representative in China is experienced and capable of handling regulatory affairs effectively.
• Timeline: Plan for adequate time to prepare documentation, undergo regulatory review, and potentially conduct clinical trials.
• Compliance: Adhere strictly to NMPA requirements and standards to avoid delays or rejection of your application.

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