Registering a medical device with the National Medical Products Administration (NMPA) in China involves several essential requirements and steps. Below is a detailed overview of the basic requirements for an NMPA registered medical device application:

1. Classification of the Medical Device

• Determine Classification: Medical devices in China are categorized into three classes (Class I, II, III) based on their risk level. Class I devices are considered low risk, Class II moderate risk, and Class III high risk. The classification will dictate the regulatory pathway and the extent of the documentation required.

2. Legal Entity Registration

• Company Registration: The applicant must be a legally registered entity in China or an overseas manufacturer with a Chinese representative office.
• Business License: A copy of the business license or equivalent documentation is required for the applicant company.

3. Product Technical Documentation

• Device Description: A detailed description of the device, including its intended use, design, manufacturing process, and materials.
• Clinical Evaluation: For Class II and III devices, a clinical evaluation report is required, which may include clinical trial data or literature review supporting the safety and efficacy of the device.
• Technical Standards Compliance: Evidence of compliance with applicable Chinese standards and international standards (e.g., ISO) is necessary.
• Risk Management: A risk management report in accordance with ISO 14971 is needed to assess potential hazards associated with the device.

4. Quality Management System (QMS)

• ISO Certification: For Class II and III devices, manufacturers must demonstrate compliance with a Quality Management System, typically ISO 13485. The NMPA may require a QMS audit by a recognized third-party organization.

5. Product Testing

• Laboratory Testing: The device must undergo testing at an NMPA-recognized laboratory to verify safety and performance. The test results must align with relevant standards.
• Test Reports: Include comprehensive test reports from authorized laboratories, demonstrating that the device meets safety, performance, and regulatory requirements.

6. Labeling and Instructions for Use

• Labels: Labels must comply with NMPA requirements, including product name, specifications, manufacturer information, and usage instructions in Chinese.
• User Manual: Detailed instructions for safe use, maintenance, and any contraindications must be provided.

7. Application Form and Fees

• Application Submission: Complete the NMPA application form, including all necessary documentation.
• Fees: Pay the applicable registration fees, which vary based on the classification of the medical device.

8. Post-Market Surveillance Plan

• Surveillance Strategy: A plan for post-market surveillance (PMS) must be developed, detailing how the manufacturer will monitor the safety and effectiveness of the device once it is on the market.

9. Ethics Approval (if applicable)

• Clinical Trials: If clinical trials are required, ethical approval from a recognized ethics committee is necessary.

10. Application Review and Approval

• Review Process: Once submitted, the NMPA will review the application. This may involve additional queries or requests for information.
• Approval Notification: If approved, the NMPA will issue a medical device registration certificate.

Conclusion

Registering a medical device with the NMPA is a rigorous process requiring thorough documentation and compliance with various regulatory standards. Manufacturers should prepare comprehensive documentation, adhere to quality standards, and understand the specific requirements for their device classification. Working with local regulatory consultants can also facilitate a smoother application process.

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