The recognition period for NMPA registered medical devices in China refers to the validity period of the Registration Certificate issued by the National Medical Products Administration (NMPA). Here’s how it typically works:

1. Initial Validity: Initially, the Registration Certificate for a medical device is typically valid for 5 years from the date of issuance.

2. Renewal: After the initial 5-year period, the Registration Certificate can be renewed for subsequent periods, usually also for 5 years at a time, upon application and approval by the NMPA.

3. Renewal Process: The renewal process involves submitting updated documentation to demonstrate continued compliance with regulatory requirements, including any changes in product specifications, manufacturing processes, or labeling since the initial registration.

4. Maintenance of Compliance: Throughout the recognition period, manufacturers must maintain compliance with relevant regulations, including adherence to Good Manufacturing Practices (GMP), post-market surveillance requirements, and timely reporting of adverse events or product recalls.

It's important for manufacturers and their Authorized Representatives in China to stay informed about any updates to regulatory requirements or changes in the renewal process to ensure continued market access for their medical devices in China.

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