Notice on "Medical Device Standard Catalog (2022 Edition)"

  Author:MeCan Medical–ultrasound machine manufacturers

Recently, the Medical Device Standard Management Center of the my country Pharmaceutical Supervision Bureau released the "Medical Device Standard Catalog (2022)" (hereinafter referred to as "Catalog Compilation"). The "Catalog" is formed for the current 1851 medical devices and industry standards in accordance with the technical field to better apply medical device standards.

The "Catalog Compilation" is divided into two categories: general technology and professional technology fields. Among them, the field of general technology includes the quality management of medical equipment, the unique logo of the medical equipment, the packaging of medical equipment, the biological evaluation of medical equipment, the general requirements of medical electrical equipment, the general technology of disinfection and sterilization, and the other 7 parts; the professional technology fields include surgery Equipment, medical biological protection, medical X -ray equipment and utensils, medical laboratories and in vitro diagnostic equipment and reagents.

The basic principles of the "Catalog Journal" are the standards of the pioneer home and the post -industry standards; the same level standards are the order in accordance with the standard number; the standards for professional and technical fields are generally common, and the post -product standards and method standards are side by side. Each standard indicates the standard number, standard name, release date, implementation date, alternative relationship (applicable to the standards that have not been implemented) and the port unit.

Medical equipment standards have played an important basic guarantee role in service science supervision and promoting industrial development. According to statistics, in 2021, my country issued a total of 35 medical equipment standards and 146 industry standards. As of February 18, 2022, a total of 1,851 current medical device standards were organized and revised by the my country Drug Administration based on responsibilities, including 235 standards (91 compulsory standards, 144 recommendation standards), and 1616 industry standards (industry standards (industry standards (industry standards (1616 industry standards (industry standards (1616 industry standards ( 298 compulsory standards and 1318 recommendation standards). There are 26 medical device standardization technical committees, sub -technical committees, and 9 medical device standardized technical batch units.

"Prank Medical Device Network" will regularly release information about medical device information on a regular basis. At the same time, as a manufacturer of medical equipment, it is rich in product types, including: clinical testing equipment, breathing anesthesia equipment, and various reagents. If you treat us to us If you are interested, please call the consultation hotline: 400-6656-888.

Notice on Medical Device Standard Catalog (2022 Edition) 1

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