The validity period of a medical device license certified by China’s National Medical Products Administration (NMPA) generally depends on the classification of the device:
Class I Devices: The registration certificate for Class I medical devices is valid for 5 years.
Class II Devices: The registration certificate for Class II medical devices is valid for 5 years.
Class III Devices: The registration certificate for Class III medical devices is valid for 5 years.
Renewal Requirements:
Application for Renewal: You must apply for renewal within the last 6 months before the certificate expires. The renewal process generally involves submitting updated documentation and possibly undergoing additional testing or review, depending on any changes to the device or regulations.
Review Process: The NMPA will review the renewal application to ensure the device continues to meet current safety and effectiveness standards.
It's crucial to keep track of the expiration dates and start the renewal process well in advance to avoid any disruptions in your device’s market availability in China.
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