NMPA certification, administered by the National Medical Products Administration, is essential for marketing medical devices in China. Here’s a detailed explanation of its scope and applicable conditions:

Scope of NMPA Certification

1. Device Categories:

   • Class I Devices: Low risk. Examples include simple bandages and non-invasive devices. These devices require a simplified registration process.
   • Class II Devices: Moderate risk. Examples include diagnostic ultrasound systems and infusion pumps. These devices require more detailed documentation and testing.
   • Class III Devices: High risk. Examples include pacemakers and artificial heart valves. These devices undergo the most rigorous scrutiny, including clinical trials and extensive testing.

2. Certification Requirements:

   • Technical Documentation: Detailed descriptions of the device, including design, materials, and intended use. For higher-risk devices, extensive clinical data may be required.
   • Manufacturing Evidence: Proof of compliance with Good Manufacturing Practices (GMP) or ISO 13485. This ensures that the device is produced under controlled and reliable conditions.
   • Quality Management System: Documentation demonstrating adherence to a robust quality management system is essential, especially for Class II and III devices.
   • Clinical Data: Clinical trials or studies may be required, particularly for Class III devices, to substantiate safety and efficacy claims.

3. Labeling and Packaging:

   • Chinese Language: Labels and instructions must be in Chinese and comply with NMPA requirements, including specific information on usage, warnings, and safety.
   • Packaging: Must meet specific standards regarding durability and safety during transport and storage.

Applicable Conditions

1. Regulatory Compliance:

   • Adherence to GB Standards: Devices must comply with relevant Chinese National Standards (GB). If no specific GB standard exists, international standards may be applied.
   • Documentation Accuracy: All submitted documents must be accurate, complete, and translated into Chinese where necessary.

2. Clinical Trials:

   • Requirement Based on Device Class: Clinical data is required for Class II and III devices, demonstrating safety and efficacy. Clinical trials must comply with Chinese regulations and may need to be conducted in China.

3. Quality Management:

   • ISO 13485: Certification to this standard is generally required. For Class III devices, more stringent quality control documentation is needed.

4. Post-Market Surveillance:

   • Ongoing Monitoring: After certification, manufacturers must monitor the device’s performance in the market, report adverse events, and take corrective actions as needed.

5. Local Agent:

   • Authorization: Foreign manufacturers must appoint a local agent in China who is responsible for regulatory communications and compliance.

6. Fees and Costs:

   • Application Fees: Fees vary depending on the device class and complexity. Payment of these fees is required for processing the application.

7. Documentation and Translation:

   • Accuracy: All technical documents, labels, and instructions must be precisely translated into Chinese and comply with local regulations.

8. Device Registration and Renewals:

   • Initial Registration: The device must be registered before it can be marketed. For Class II and III devices, this involves a more detailed review process.
   • Renewals and Updates: Regular updates and renewals may be required, especially if there are significant changes to the device or its labeling.

By understanding these scope and conditions, manufacturers can ensure that their medical devices meet NMPA requirements and are successfully registered for sale in China.

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