In order to implement the requirements of “streamlining administration, delegating power, strengthening regulation, and improving services” and improve the accessibility of medical device standards, the Center for Medical Device Standard Management of the National Medical Products Administration organized to compile a new Medical Device Standard Catalog Compilation (see the Annex) with 1,791 current effective national and industrial standards for medical devices by technical fields.
The Catalog Compilation is divided into general technical fields and professional technical fields. General technical fields include 7 parts, medical device quality management, unique device identification, medical device packaging, biological evaluation of medical devices, general requirements for medical electrical equipment, and general technology for disinfection and sterilization, etc. Professional technical fields include 32 parts, surgical instruments, medical biological protection, medical X-ray equipment and appliances, medical laboratory and in vitro diagnostic instruments and reagents, etc.
The Catalog Compilation is now promulgated.
The Catalog Compilation is divided into general technical fields and professional technical fields. General technical fields include 7 parts, medical device quality management, unique device identification, medical device packaging, biological evaluation of medical devices, general requirements for medical electrical equipment, and general technology for disinfection and sterilization, etc. Professional technical fields include 32 parts, surgical instruments, medical biological protection, medical X-ray equipment and appliances, medical laboratory and in vitro diagnostic instruments and reagents, etc.
The Catalog Compilation is now promulgated.
The Center for Medical Device Standard Management of the National Medical Products Administration
May 21, 2021
May 21, 2021