Introduction to the compilation of guidelines for the naming of common names in various professional fields of medical devices in China

The name of medical device products involves registration/filing, production, circulation, use and other links. In order to connect and coordinate with relevant regulations, the Medical Device Standards Management Center of the State Drug Administration refer to the sub-category of the Medical Device Classification Catalogue released in 2017,and set up a professional domain structure of common name naming guidelines .

The guiding principles for generic nomenclature of medical devices was issued in December 2019, which specifies the scope of application and explicitly excludes in vitro diagnostic reagents managed according to medical devices; The structure and requirements of common names are detailed, and the naming guidelines and the compilation requirements of nomenclature in various professional fields are given.

At present, the Guiding Principles for the Naming of Common Names of Medical Imaging Devices, Guiding Principles for the Naming of Generic Names of Active Implantable Devices, Guiding Principles for the Naming of Common Names of Dental Devices, Guiding Principles for the Naming of Common Names of Orthopedic Surgical Devices, Guidelines for the Naming of Generic Names of Transfusion,Dialysis and Extracorporeal Circulation Devices, Guidelines for the Naming of Generic Names of Passive Surgical Devices, Guidelines for the Naming of Generic Names of Passive Implant Devices, Guidelines for the Naming of Generic Names of Sterilization  Devices have been formulated and released in June 2020 and December 2020.The technical review of 14 guiding principles including Guiding Principles for Naming Generic Names of Radiotherapy Devices and Guiding Principles for Naming Generic Names of Active Surgical Devices has been completed.

The guiding principles for the naming of common names in various professional fields of medical devices clarifies the principles for selecting core words and characteristic words for products in this field, the naming structure of common names, and listing product categories, optional term names and descriptions in the form of a naming glossary. Typical examples are used to guide the formulation of common names and provide users with a directly searchable “term name set”.

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