Medical device common name naming rules

Article I In order to strengthen the supervision and management of medical devices, to ensure that the medical device generic name naming scientific and standardized, according to the "supervision and management of medical devices regulations", the development of these rules. Article 2 Where in the Chinese people's *** and the territory of the sale, use of medical devices should be used in the generic name, generic name naming should be consistent with these rules. Article 3 The generic name of medical devices shall comply with relevant state laws and regulations, scientific, clear, and consistent with the real attributes of the product. Article 4 The common name of medical devices should be used in Chinese, in line with national language and writing standards. Article V has the same or similar intended purpose, *** the same technology with the same variety of medical devices should use the same common name. Article VI of the common name of medical devices by a core word and generally no more than three characteristic words.

The core word is to have the same or similar technical principles, structural composition or the intended purpose of the general expression of medical devices.

Feature word is the use of medical devices, structural characteristics, technical characteristics or material composition and other specific attributes of the description. Use part refers to the role of the product in the human body, can be the human body's systems, organs, tissues, cells and so on. Structural characteristics of the product is a specific structure, appearance and shape of the description. Technical characteristics are the description or qualification of the product's special action principle, mechanism or special performance. Material composition is the main material or the main component of the product description. Article VII of the common name of medical devices in addition to the provisions of Article VI of these rules should be consistent with, shall not contain the following:

(a) models, specifications;

(b) graphics, symbols and other signs;

(d) "the best ", "the only", "precise", "fast-acting" and other absolutist and exclusive words, or assertions or guarantees that indicate the efficacy of the product;

(E) the terms of the effective rate, cure rate;

(F) without scientific proof or clinical evaluation of the proof, or false, hypothetical conceptual name;

(G) express or implied cure for all diseases, exaggerated the scope of application, or other misleading, deceptive content;

(H) "beauty ", "health care" and other promotional terms;

(ix) other content prohibited by relevant laws and regulations. Article 8 According to the provisions of Article 11(1) of the Trademark Law of the People's Republic of China*** and the State, the generic name of medical devices shall not be registered as a trademark. Article 9 The naming of in vitro diagnostic reagents managed in accordance with medical devices shall be implemented in accordance with the relevant provisions of the Measures for the Administration of the Registration of In Vitro Diagnostic Reagents (Decree No. 5 of the State Food and Drug Administration). Article 10 These rules shall come into force on April 1, 2016 onwards.