The validity period and certificate renewal requirements for the Chinese NMPA certified Traditional Chinese Medicine (TCM) Device License typically include the following:

1. Validity Period: The initial validity period of an NMPA certified TCM Device License is typically 5 years. This means the certificate is valid for importing and selling the specified TCM device in China for that duration.

2. Renewal Requirements: To renew the TCM Device License after the initial 5-year period, manufacturers must typically submit a renewal application to NMPA. The renewal application process generally involves:

   • Documentation: Manufacturers need to provide updated technical documentation, including any changes made to the device, manufacturing processes, or quality management systems since the initial certification.

   • Compliance Verification: NMPA may review the device's compliance with current regulatory standards and verify that the device continues to meet safety and efficacy requirements.

   • Post-Market Surveillance Data: Manufacturers may need to submit post-market surveillance data and reports to demonstrate the device's performance and safety during its use in the market.

   • Fees: There may be fees associated with the renewal application, which vary depending on the type of device and specific NMPA requirements.

3. Continued Compliance: Throughout the validity period and during the renewal process, manufacturers are expected to maintain compliance with NMPA regulations, including ongoing adherence to quality management systems, reporting of adverse events, and any other regulatory obligations.

Renewing the TCM Device License ensures that manufacturers can continue to import and sell their TCM devices in China legally, while also ensuring ongoing compliance with Chinese regulatory standards and requirements.