The National Drug Administration has issued 6 guidelines for naming common names of medical devices
Release Time:
2023-01-31
China Food and Drug Network News On July 15th, The National Drug Administration has issued the "Guidelines for Naming Common Names of Medical Rehabilitation Devices", "Guidelines for Naming Common Names of Traditional Chinese Medicine Devices", "Guidelines for Naming Common Names of Radiation Therapy Devices", "Guidelines for Naming Common Names of Medical Software", "Guidelines for Naming Common Names of Respiratory, Anesthetic, and First Aid Devices", and "Guidelines for Naming Common Names of Obstetrics and Gynecology, Assisted Reproductive, and Contraceptive Devices" Six guiding principles for naming common names, further standardizing the common names of medical devices, and strengthening the full lifecycle management of medical devices
The Guiding Principles for Naming Common Names of Medical Rehabilitation Devices are applicable to medical rehabilitation equipment products, mainly including hearing aids, speech aids, rehabilitation training equipment, walking aids, orthopedic fixed devices, and other medical rehabilitation equipment. The Guiding Principles for Naming Common Names of Traditional Chinese Medicine Devices are applicable to traditional Chinese medicine device products, mainly including traditional Chinese medicine diagnostic equipment, traditional Chinese medicine treatment equipment, and traditional Chinese medicine devices. The Guiding Principles for Naming Common Names of Radiation Therapy Devices are applicable to the determination of common names for radiation therapy device products. The Guidelines for Naming Medical Software Common Names apply to medical independent software medical devices, excluding software components (non independent software). The Guiding Principles for Naming Common Names of Respiratory, Anesthetic, and First Aid Equipment are applicable to respiratory, anesthetic, and first aid equipment products, mainly including respiratory equipment, anesthesia equipment, first aid equipment, medical gas equipment, gas supply equipment, pipeline masks, and other equipment as well as accessories. The Guiding Principles for Naming Common Names of Obstetrics and Gynecology, Assisted Reproduction, and Contraceptive Devices are applicable to specialized devices in obstetrics and gynecology, assisted reproduction, and contraception
The above guidelines for naming universal names are formulated in accordance with the "Naming Rules for Medical Device Universal Names" and the "Guidelines for Naming Medical Device Universal Names", which clarify the principles for formulating core words, feature words, and default feature words for corresponding categories of products. They also specify the principles for determining the composition structure of universal names, the selection of core words, and feature words, and provide a detailed list of optional naming terms and descriptions in the form of a nomenclature, And guide naming through typical examples. (Yan Ruoyu)
Source of this article: China Food and Drug Network
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