The NMPA (National Medical Products Administration) registration process for medical devices in China involves several key steps. Here’s an overview of the typical license application process:

1. Pre-Application Preparation

1.1. Understand NMPA Regulations:

• Review relevant NMPA regulations, guidelines, and standards for your medical device classification (Class I, II, or III).

1.2. Device Classification:

• Confirm the classification of your device to determine the specific requirements and documentation needed.

2. Documentation and Preparation

2.1. Gather Required Documents:

• Product Information: Description, specifications, intended use, and performance characteristics.
• Manufacturing Information: Manufacturer’s details, QMS certification (e.g., ISO 13485).
• Clinical Data: Clinical evaluation reports, trial data, if applicable.
• Safety and Performance Testing: Reports from accredited labs.
• Labeling and IFU: Labels and instructions for use in Chinese.

2.2. Translate Documents:

• Ensure all documents are translated into Chinese by certified translators.

3. Application Submission

3.1. Complete Application Form:

• Fill out the NMPA application form, including all required details about the device and manufacturer.

3.2. Compile and Submit Documentation:

• Organize and submit all required documents to the NMPA. Ensure all materials are complete and compliant with their guidelines.

3.3. Pay Fees:

• Submit proof of payment for application and registration fees.

4. Review and Assessment

4.1. Application Review:

• NMPA reviews the submitted application and documents. They may request additional information or clarification.

4.2. Technical Review:

• The application undergoes a technical review to assess compliance with safety and performance standards.

4.3. Possible Facility Inspection:

• An on-site inspection of the manufacturing facility may be conducted if required.

5. Approval and Certification

5.1. Approval Decision:

• NMPA makes a decision on the application based on the review. If approved, they issue a registration certificate.

5.2. Issuance of License:

• Receive the NMPA registration certificate or license for your medical device.

6. Post-Certification Requirements

6.1. Post-Market Surveillance:

• Implement a system to monitor device performance and report adverse events.

6.2. Renewal and Updates:

• Ensure timely renewal of certification and update NMPA on any changes to the device or its manufacturing process.

Additional Considerations

• Consult Local Experts: Engage regulatory consultants familiar with NMPA procedures to guide you through the process.
• Stay Updated: Keep abreast of any changes in NMPA regulations or guidelines to ensure ongoing compliance.

By following these steps, you can effectively navigate the NMPA registration process and achieve compliance for your medical device in China.

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