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Recently, the Medical Device Standards Management Center of the State Food and Drug Administration released the "Compilation of Medical Device Standards Catalogue (2022 Edition)" (hereinafter referred to as the "Catalogue Compilation")
.
The Catalogue is a compilation of the current 1,851 national and industry standards for medical devices by technical fields, in order to better apply medical device standards
.
The Catalogue is divided into two categories: general technical fields and specialized technical fields
.
Among them, the general technical field includes medical device quality management, medical device unique identification, medical device packaging, medical device biological evaluation, general requirements for medical electrical equipment, disinfection and sterilization general technology and other 7 parts; professional technical fields include surgical instruments , medical biological protection, medical X-ray equipment and appliances, medical laboratory and in vitro diagnostic equipment and reagents and other 32 parts
.
The basic principle for the compilation of the Catalogue is that the national standards are first followed by the industry standards; the standards at the same level are in the order of standard numbering; the standards in the professional technical field are firstly general standards, followed by product standards, method standards, and series or similar standards
.
For each standard, the standard number, standard name, release date, implementation date, substitution relationship (applicable to standards that have been released but not implemented) and the focal point are indicated
.
Medical device standards have played an important basic role in serving scientific supervision and promoting industrial development
.
According to statistics, in 2021, China will issue a total of 35 national standards for medical devices and 146 industry standards
.
As of February 18, 2022, a total of 1,851 current medical device standards have been formulated and revised by the State Food and Drug Administration according to their responsibilities, including 235 national standards (91 mandatory standards, 144 recommended standards) and 1,616 industry standards.
(298 mandatory standards, 1318 recommended standards)
.
There are currently 26 technical committees and sub-technical committees for medical device standardization, and 9 technical focal points for medical device standardization
.
(Yan Ruoyu)
.
The Catalogue is a compilation of the current 1,851 national and industry standards for medical devices by technical fields, in order to better apply medical device standards
.
The Catalogue is divided into two categories: general technical fields and specialized technical fields
.
Among them, the general technical field includes medical device quality management, medical device unique identification, medical device packaging, medical device biological evaluation, general requirements for medical electrical equipment, disinfection and sterilization general technology and other 7 parts; professional technical fields include surgical instruments , medical biological protection, medical X-ray equipment and appliances, medical laboratory and in vitro diagnostic equipment and reagents and other 32 parts
.
The basic principle for the compilation of the Catalogue is that the national standards are first followed by the industry standards; the standards at the same level are in the order of standard numbering; the standards in the professional technical field are firstly general standards, followed by product standards, method standards, and series or similar standards
.
For each standard, the standard number, standard name, release date, implementation date, substitution relationship (applicable to standards that have been released but not implemented) and the focal point are indicated
.
Medical device standards have played an important basic role in serving scientific supervision and promoting industrial development
.
According to statistics, in 2021, China will issue a total of 35 national standards for medical devices and 146 industry standards
.
As of February 18, 2022, a total of 1,851 current medical device standards have been formulated and revised by the State Food and Drug Administration according to their responsibilities, including 235 national standards (91 mandatory standards, 144 recommended standards) and 1,616 industry standards.
(298 mandatory standards, 1318 recommended standards)
.
There are currently 26 technical committees and sub-technical committees for medical device standardization, and 9 technical focal points for medical device standardization
.
(Yan Ruoyu)
