NMPA orders active medical device use period clarity

China’s National Medical Products Administration (NMPA) released a set of guidelines in relation to active medical devices. The guidance calls for research into such devices to take into account the product lifespan, requires medical device applicants/registrants to include the active medical device use period within filings, and also provides guidance for reviewers.

The active medical device lifespan is referred to as an applicable range where the medical device applicants/registrants ensure the products’ safety and efficacy via risk management. The medical device applicants are required to specify the use period of the product within filings, alongside relevant verification information, according to China’s medical device laws and regulations on product use and validity period.


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