The State Food and Drug Administration issued 6 common name naming guidelines for medical devices

Release time:

2023-01-16

China Food and Drug Network News July 15, the State Food and Drug Administration has issued six common name naming guiding principles, namely, Guiding Principles for Common Names of Medical Rehabilitation Devices, Guiding Principles for Common Names of Traditional Chinese Medicine Devices, Guiding Principles for Common Names of Radiotherapy Devices, Guiding Principles for Common Names of Medical Software, Guiding Principles for Common Names of Respiratory, Anesthesia and Emergency Devices, and Guiding Principles for Common Names of Obstetrics and Gynecology, Assisted Reproductive and Contraceptive Devices, further standardize the generic name of medical devices and strengthen the management of the whole life cycle of medical devices.

The Guiding Principles for the Naming of General Names of Medical Rehabilitation Devices are applicable to medical rehabilitation devices, mainly including hearing aids, speaking aids, rehabilitation training equipment, walking aids, orthopedic fixation devices and other medical rehabilitation devices. The Guiding Principles for the Naming of Common Names of TCM Instruments apply to TCM instrument products, mainly including TCM diagnostic equipment, TCM treatment equipment and TCM instruments. The Guidelines for the Naming of Common Names of Radiotherapy Devices are applicable to the determination of common names of radiotherapy devices. The Common Naming Guidelines for Medical Software are applicable to medical stand-alone software medical devices, excluding software components (non-stand-alone software). The Guiding Principles for the Common Names of Respiratory, Anaesthetic and First Aid Devices apply to respiratory, anesthetic and first aid products, mainly including respiratory equipment, anesthetic equipment, first aid equipment, medical gas equipment, gas supply equipment, pipeline masks and other equipment and accessories. The Guidelines for the Nomenclature of Gynecology and Obstetrics, Assisted Reproductive and Contraceptive Devices apply to specialized devices for obstetrics and gynecology, assisted reproduction and contraception.

The above general name naming guidelines are formulated according to the General Name Naming Rules for Medical Devices and the General Name Naming Guidelines for Medical Devices, defining the default formulation principles of the core words, feature words and feature words of the corresponding categories of products, specifying the determination principles such as the composition structure of the general name, the selection principles of the core words and feature words, and detailing the optional naming terms and descriptions in the form of naming terms, and guide the naming through typical examples. (Yan Ruoyu)

Source: China Food and Drug Network

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