In order to supervise medical device registrants taking the responsibilities for medical device quality and safety thoroughly and strengthen the implementation of the responsibilities for personnel of quality and safety in production of medical device and operation enterprises, the Chinese health authority NMPA has issued  the so-called “Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety” according to < Regulation on the Supervision and Administration of Medical Devices (医疗器械监督管理条例)>, < Measures for Supervision and Administration of Medical Device Production (医疗器械生产监督管理办法)> , and <Measures for Supervision and Administration of Medical Device Operation (医疗器械经营监督管理办法)>.

The regulation is hereby issued and comes into force from 1st March 2023.

Attachment:

NMPA Announcement on Issuing the "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety"

 

 

Reference:
NMPA Announcement on Issuing the "Regulations on Enterprises Implementing the Supervision and Management of Subject Responsibilities for Medical Device Quality and Safety"

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