To entirely comply the implementation of the Regulations on the Supervision and Administration of Medical Devices and further standardize the supervision and management of medical device manufacturing in China, NMPA has drafted a set of Measures for Medical Device Registration (Revised draft for comments) and currently seeking for public opinion and comments for processing the official Announcement’s publication.

Set of Administrative Measures for Medical Device Registration are as follow:

  1. 1. Administrative Measures for Medical Device Registration
       (Revised Draft for Comment)
  2. 2. Measures for Supervision and Administration of Medical Devices Operations License
        (Revised Draft for Comments)
  3. 3. Measures for Supervision and Administration of Medical Devices Manufacturing
        (Revised Draft for Comments)
  4. 4. Measures for the Registration and Administration of In vitro Diagnostic Device
        (Revised Draft for Comment)

Order No.739 decree shall be in force by June 1st, 2021 onwards.

Reference:

Administrative Measures for Medical Device Registration (Revised Draft for Comment)

Measures for Supervision and Administration of Medical Devices Operations License (Revised Draft for Comments)

Measures for Supervision and Administration of Medical Devices Manufacturing (Revised Draft for Comments)

Measures for the Registration and Administration of In vitro Diagnostic Device (Revised Draft for Comment)

<Regulations on the Supervision and Administration of Medical Devices> Devices Order No. 739 of the State Council

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