article 1 in order to strengthen the supervision and administration of medical devices and ensure the scientific and standardized naming of common names of medical devices, these rules are formulated in accordance with the regulations on the supervision and administration of medical devices. Article 2 All medical devices sold and used in the People's Republic of China shall use generic names, and the naming of generic names shall conform to these Rules. Article 3 The generic names of medical devices shall conform to the provisions of relevant national laws and regulations, be scientific and clear, and be consistent with the true attributes of products. Article 4 The generic names of medical devices shall be in Chinese and conform to the national language and writing standards. Article 5 Medical devices of the same variety with the same or similar expected purpose and the same technology shall use the same generic name. Article 6 The generic name of medical devices consists of a core word and generally no more than three characteristic words.

Core words are general expressions of medical devices with the same or similar technical principles, structural components or expected purposes.

a characteristic word is a description of the specific attributes of medical devices, such as the use position, structural characteristics, technical characteristics or material composition. The use site refers to the action site of the product in the human body, which can be the system, organ, tissue and cell of the human body. The structural feature is the description of the specific structure and appearance of the product. The technical feature is the explanation or limitation of the principle, mechanism or special performance of the product. Material composition is a description of the main materials or components of a product. Article 7 The generic names of medical devices shall not contain the following contents except the provisions of Article 6 of these Rules:

(1) Model and specification;

(2) signs such as figures and symbols;

(3) a person's name, enterprise name, registered trademark or other similar names;

(4) absolute and exclusive words such as "best", "unique", "accurate" and "quick-acting", or assertions or guarantees indicating product efficacy;

(5) terms describing the effective rate and cure rate;

(6) Conceptual names that have not been proved by scientific or clinical evaluation, or that are empty or hypothetical;

(7) express or imply a cure for all diseases, exaggerate the scope of application, or other misleading or deceptive content;

(8) propaganda words such as "beauty" and "health care";

(9) other contents prohibited by relevant laws and regulations. Article 8 According to the provisions of Paragraph 1 of Article 11 of the Trademark Law of the People's Republic of China, the generic names of medical devices shall not be registered as trademarks. Article 9 The naming of in vitro diagnostic reagents under the management of medical devices shall be implemented in accordance with the relevant provisions of the Measures for the Administration of Registration of in vitro diagnostic reagents (china food and drug administration Decree No.5). Article 1 These Rules shall come into force as of April 1, 216.