General name naming rules for medical devices (Order No. 19 of State Food and Drug Administration)

Source: CFDA 2015-12-24 Order No 19 of the State Food and Drug Administration of the people's Republic of China on the naming rules for general names of medical devices, which was deliberated and adopted at the executive meeting of the State Food and Drug Administration on December 8, 2015, is hereby promulgated and shall come into force as of April 1, 2016 Bi Jingquan, director of the Bureau, made these rules in accordance with the regulations on the supervision and administration of medical devices in accordance with Article 1 of the rules for the naming of general names of medical devices on December 21, 2015 to strengthen the supervision and administration of medical devices and ensure that the naming of general names of medical devices is scientific and standardized Article 2 all medical devices sold and used within the territory of the people's Republic of China shall use a common name, which shall conform to these rules Article 3 the general name of medical devices shall conform to the relevant laws and regulations of the state, be scientific and clear, and be consistent with the true attributes of the products Article 4 the general name of the medical device shall be in Chinese and conform to the national language and character standards Article 5 the same general name shall be used for the same type of medical devices with the same or similar expected purpose and common technology Article 6 the general name of medical devices consists of one core word and generally no more than three characteristic words The core words are the general expressions of medical devices with the same or similar technical principles, structural components or intended purposes Characteristic words describe the specific properties of medical devices, such as the use position, structural characteristics, technical characteristics or material composition The use part refers to the functional part of the product in the human body, which can be the system, organ, tissue, cell, etc of the human body The structural feature is the description of the specific structure and appearance of the product The technical characteristics are the description or limitation of the special action principle, mechanism or special performance of the product Material composition is a description of the main materials or components of a product Article 7 in addition to complying with the provisions of Article 6 of these rules, the general name of medical devices shall not contain the following contents: (1) model and specification; (2) graphics, symbols and other signs; (3) name of person, enterprise, registered trademark or other similar names; (4) "best", "unique" and "accurate" "," quick effect "and other absolute and exclusive words, or the assertion or guarantee of product efficacy; (5) the words indicating the effective rate and cure rate; (6) the conceptual name without scientific proof or clinical evaluation, or nihility or hypothesis; (7) explicitly or impliedly cure all diseases, exaggerate the scope of application, or other misleading and deceptive contents; (8) "beauty", "health care" and other promotional words; (9) other contents prohibited by relevant laws and regulations Article 8 according to the first paragraph of Article 11 of the Trademark Law of the people's Republic of China, the general name of medical devices shall not be registered as a trademark Article 9 the name of the in vitro diagnostic reagents under the management of medical devices shall be in accordance with the relevant provisions of the administrative measures for the registration of in vitro diagnostic reagents (Order No 5 of the State Food and Drug Administration) Article 10 these Rules shall come into force as of April 1, 2016.