On February 21, 2022, the Food and Drug Administration issued a notice to publish the “Compilation of Medical Device Standard Catalog (2022 Edition)”.
Original notice:
In order to facilitate the better application of medical device standards, the Medical Device Standards Management Center of the State Food and Drug Administration organized and compiled the current 1,851 national and industry standards for medical devices according to technical fields to form the “Medical Device Standard Catalog Compilation (2022 Edition)”.
The catalog is divided into two categories: general technical fields and professional technical fields. The general technical fields include medical device quality management, unique identification of medical devices, medical device packaging, biological evaluation of medical devices, general requirements for medical electrical equipment, general technologies for disinfection and sterilization, and 7 other parts. The professional technical fields include 32 parts including surgical instruments, medical biological protection, medical X-ray equipment and appliances, medical laboratory and in vitro diagnostic equipment and reagents.
Now made public.
Medical Device Standards Management Center of the State Food and Drug Administration
February 21, 2022
Attachment: Compilation of Medical Device Standard Catalog (2022 Edition)