In order to further standardize the generic names of medical devices and strengthen the management of the whole lifecycle of medical devices, NMPA has organized and formulated six naming guidelines, namely:
- Naming guidelines for the generic name of medical rehabilitation devices;
- Naming guidelines for the generic name of traditional Chinese medicine (TCM) devices;
- Naming guidelines for the generic name of radiotherapy devices;
- Naming guidelines for the generic name of medical software;
- Naming guidelines for the generic name of respiratory, anesthetic, and first-aid devices;
- Naming guidelines for the generic name of obstetrics and gynecology, assisted reproduction, and contraceptive devices
Typically, the generic name is accorded based on the structure of "feature word 1 (if any) + feature word 2 (if any) + feature word 3 (if any) + core word". Core and feature words should be selected from the NMPA-prepared glossary first, listed in the guidelines. They must be based on the true attributes and characteristics of the product. For a new feature reflected in a new product or original product and is not included in the current glossary, or when a new term needs to be added, the glossary can be supplemented or adjusted accordingly.
A core word is a general expression of a device with the same or similar technical principles, structural composition, or intended purpose. The selection of feature words mainly involves the following aspects: the use of parts, structural characteristics, technical characteristics, material composition, form of supply and so on. A feature word that is commonly used or recognized under a feature term in the glossary may be set to "default" and not reflected in generic names to comply with conventions, simplify names, and facilitate expression.
Notice of NMPA on issuing 6 Guidelines including Naming Guidelines for Generic name of medical rehabilitation devices（No.48, 2021）