The registration validity period for NMPA-certified medical devices in China varies depending on the classification of the device:

1. Class I Devices

• Validity Period: Class I devices are typically exempt from the need for a registration certificate and are subject to a simpler management system. Therefore, they do not have a specific registration validity period and can be marketed as long as they comply with applicable regulations.

2. Class II Devices

• Validity Period: The registration certificate for Class II devices is generally valid for 5 years. After this period, manufacturers must apply for renewal to continue marketing the device.

3. Class III Devices

• Validity Period: Similar to Class II devices, the registration certificate for Class III devices is also valid for 5 years. Renewal is required after this period.

4. Renewal Process

• The renewal process involves submitting a renewal application to the NMPA, including updated documentation, post-market surveillance data, and any new evidence regarding the device's safety and effectiveness. The NMPA may conduct a review of the device's compliance with current standards and regulations.

5. Post-Market Surveillance

• Manufacturers are required to engage in post-market surveillance throughout the validity period of the registration. This includes reporting adverse events, conducting quality control, and ensuring that the device continues to meet regulatory standards.

Conclusion

In summary, while Class I devices do not have a registration validity period, both Class II and III medical devices are valid for 5 years, after which renewal is necessary to maintain compliance and continue marketing in China.