Regulations on Customized Medical Device Supervision and Management (Trial Version) in China

New regulations on customized medical devices in China

On July 4th, the National Medical Products Administration (NMPA) issued “customized medical device supervision and management regulations (Trial Version) (NMPA order No. 53 2019)” implemented from January 1st, 2020. The target of the regulations is to meet the clinical personalized demands and ensure the effectiveness and safety of customized medical devices.

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