Recently, the Medical Device Standard Management Center of the State Food and Drug Administration released the Compilation of Medical Device Standard Catalogue (version 2022) (hereinafter referred to as the Catalog Compilation). The catalogue is a compilation of 1851 current national and industrial standards for medical devices in terms of technical fields, so as to better apply medical device standards.

The catalogue is divided into general technical field and specialized technical field. Among them, the general technology field includes medical device quality management, medical device unique identification, medical device packaging, medical device biological evaluation, medical electrical equipment general requirements, 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 instruments and reagents, and other 32 parts.

The basic principle of catalogue compilation is national standard first and industrial standard second. The corresponding standards shall be numbered in sequence; Professional and technical field standards are general standards first, followed by product standards, method standards, series or similar standards side by side. For each standard, the standard number, standard name, date of publication, date of implementation, substitution relationship (published but not implemented standards apply) and the unit of reference are indicated.

Medical device standards play an important role in serving scientific supervision and promoting industrial development. According to statistics, in 2021, China issued a total of 35 national standards for medical devices and 146 industry standards. As of February 18, 2022, a total of 1851 medical device standards have been revised by SFDA according to its responsibilities, including 235 national standards (91 mandatory standards and 144 recommended standards) and 1616 industry standards (298 mandatory standards and 1318 recommended standards). There are 26 medical device standardization technical committees and sub-technical committees, and 9 medical device standardization technical centers.