For NMPA (National Medical Products Administration) registration of medical devices in China, you need to compile and submit a comprehensive set of documents and materials. Below is a detailed list of the required documents and materials:

1. Application Forms

1.1 Application Form:

• Complete and sign the NMPA medical device registration application form. This form includes information about the device, manufacturer, and intended use.

2. Manufacturer Information

2.1 Manufacturer's Business License:

• A copy of the business license of the manufacturer, showing its legal status and business scope.

2.2 Quality Management System Certification:

• Proof of compliance with ISO 13485 or other relevant quality management standards. Provide certificates and documentation of the quality management system.

2.3 Manufacturing Capability:

• Detailed information about the manufacturing process, facilities, and equipment used to produce the device.

3. Product Information

3.1 Product Description:

• A detailed description of the device, including its intended use, indications, contraindications, and any specific features or functionalities.

3.2 Technical Specifications:

• Detailed technical specifications, including design drawings, materials used, and performance characteristics.

3.3 User Manual:

• A comprehensive user manual or instructions for use (IFU), translated into Chinese. This should include detailed operating instructions, safety information, and troubleshooting guidelines.

3.4 Labeling:

• Copies of all labels and packaging materials in Chinese, including product name, manufacturer information, and usage instructions.

4. Clinical Data

4.1 Clinical Evaluation Report:

• A report demonstrating the safety and effectiveness of the device based on clinical trials or relevant studies. Required for Class II and III devices.

4.2 Clinical Trial Data:

• If applicable, provide data from clinical trials conducted in accordance with NMPA guidelines. Include trial protocols, results, and any related documentation.

5. Technical Documentation

5.1 Design and Development Records:

• Documentation related to the design and development of the device, including design input, design output, and design validation records.

5.2 Risk Management Report:

• A risk management report identifying potential risks associated with the device and measures taken to mitigate those risks.

5.3 Testing Reports:

• Reports from safety and performance tests conducted according to NMPA standards. This may include electrical safety tests, biocompatibility tests, and other relevant assessments.

5.4 Manufacturing Process Documentation:

• Details of the manufacturing process, including process validation and quality control procedures.

6. Translation and Notarization

6.1 Document Translation:

• All documents submitted to the NMPA must be translated into Chinese by a certified translator familiar with medical terminology.

6.2 Notarization:

• Certain documents, such as manufacturer’s certification and clinical data, may need to be notarized. Verify which documents require notarization and ensure they are properly notarized.

7. Additional Requirements

7.1 Declaration of Conformity:

• A declaration stating that the device conforms to applicable Chinese regulations and standards.

7.2 Power of Attorney:

• If the registration is handled by an agent or distributor in China, include a power of attorney authorizing them to act on behalf of the manufacturer.

7.3 Post-Market Surveillance Plan:

• A plan outlining how the device will be monitored post-market for safety and effectiveness, including procedures for reporting adverse events and conducting recalls.

8. Application Submission

8.1 Submission:

• Submit the completed application and all required documents through the NMPA’s online system or to a local NMPA office, depending on the device category and specific requirements.

8.2 Fees:

• Pay any applicable registration fees as required by the NMPA. Ensure that payment is processed according to NMPA guidelines.

9. Follow-Up

9.1 Monitor Application Status:

• Track the status of your application and be prepared to respond to any requests for additional information or clarification from the NMPA.

9.2 Address Queries:

• Address any queries or requests for additional documentation promptly to avoid delays in the registration process.

Recommendations

• Consult Local Experts: Engage with regulatory consultants or legal experts who specialize in NMPA submissions to ensure compliance and smooth processing.
• Review Regulations: Regularly review NMPA guidelines and updates to stay informed about any changes in the registration process.
• Prepare for Audits: Be ready for possible audits or inspections by the NMPA, including providing access to manufacturing facilities and records if required.

By thoroughly preparing these documents and adhering to NMPA requirements, you can facilitate a successful registration process for your medical device in China.

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