The license period for NMPA registration of medical devices in China typically lasts for 5 years. After this period, manufacturers must apply for renewal to continue selling their devices in China.

For renewal, the NMPA requires updated documentation to ensure the device continues to meet regulatory and safety standards. This process may include submitting post-market surveillance data, clinical trial results (if applicable), and any updates to the device’s design, labeling, or intended use. If significant changes have occurred, the NMPA may require a new registration process.

Manufacturers should begin the renewal process well before the expiration date to avoid any interruptions in market access.