Recently, the State Food and Drug Administration issued a general name for medical devices named rules (hereinafter referred to as the rules), will be implemented in April 1, 2016.

It is very important to accurately identify and correctly use medical devices, and it is the important basic work of medical device registration and supervision. "Medical equipment supervision and management regulations" (the State Council Decree No. 650th) twenty-sixth, clearly stipulates that medical devices should be using a common name, generic name should be in line with the rules of nomenclature of medical equipment. Administration in reference to global medical device nomenclature system (GMDN) construction ideas, with reference to the United States, the European Union, Japan and other countries and regions of medical devices named requirements and practices, the reference drug generic name naming format and content based, in-depth research and extensive solicitation of opinions, organizing the formulation of the rules.
The "rules" of a total of ten, mainly including the following aspects: one is clearly the legislative basis of the "rules" is the "medical equipment supervision and management regulations", the scope of application is listed sale and use of medical products in our country, the specification of the object is medical equipment common name. Two is to clarify the principles of the universal name of medical equipment, should be legal, scientific, clear, real, should use Chinese, and in line with the national language specification. Three is to make clear the generic name for the content and structure, with identical or similar to the expected goal, the common technology of varieties of the same medical instruments shall use the same common name; common name consists of a core word and generally not more than three feature words and the content of core words and characteristic words are described. Four is to make clear of the generic name of prohibited content, common name in addition to meet the corresponding requirements of the "rules" provisions, shall not contain "models, specifications" and "graphics, symbols symbol", "name, enterprise name, registered trademark or other similar name," best and exclusive, accurate, quick and absolute, exclusive of the words "," explains efficiency, the cure rate of the term "nine requirements prohibiting. Five is clear and other content related to generic names, common names shall not be registered as a trademark. According to the medical management of in vitro diagnostic reagents named in accordance with provisions of the administration of the first five orders of execution. Six is considering issuing regulations to be carried out after the publicizing and training and preparation work, determine the implementation date for the 2016 April 1st.
There are a great variety of medical device products, a large difference in composition and structure, and the general idea of the naming management of medical equipment is: "rule command, term support, database landing". In accordance with the above requirements, the need to establish a "rule - Terminology - generic name database" architecture of the medical device nomenclature system. Introduced naming rules, to exist in the name of product structure of words and disable word regulated solution due to naming is not accurate, scientific and medical device name confusion, misleading recognition; based on a nomenclature and generic name database, the generic name layer and sequence, terminology and standard system, and gradually realize the medical device name standardization management. As a "medical equipment supervision and management regulations," the supporting rules, "rules" is the first generic name for the medical device regulatory documents, is the standard guide the general name of the program and the basic principles. The introduction of rules, marking the generic names of China's medical device named work into the legal track, to perfect our country's medical device regulatory system, strengthening supervision of the foundation is of great significance.