Rules for Medical Device Nomenclature

 (Decree No. 19 of China Food and Drug Administration)

Issued on December 21, 2015

Decree of China Food and Drug Administration

No.19

The Rules for Medical Device Nomenclature, adopted at the executive meeting of China Food and Drug Administration on December 8, 2015, is hereby promulgated and shall be effective as of April 1, 2016.

Rules for Medical Device Nomenclature

Article 1 The Rules is formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices to enhance the supervision and administration of medical devices and ensure that the nomenclature of medical devices is scientific and normative.

Article 2 All medical devices that are sold and used within the territory of the People's Republic of China shall use generic names and their naming shall conform to the Rules.

Article 3 The generic names of medical devices shall conform to relevant national laws and regulations, and shall be scientific, explicit and consistent with the actual attributes of the products.

Article 4 The generic names of medical devices shall be in Chinese and conform to the norms of the standard spoken and written Chinese language.

Article 5 The same generic name shall apply to medical devices in the same category with the same or similar intended use and common technologies.

Minister: Bi Jingquan

December 21, 2015

Article 6 The generic name of a medical device is composed of a core word and generally no more than three feature words.

The core word is a generalized expression for medical devices with the same or similar technical principles, structure or intended use.

The feature word is a description of the specific attribute of the medical device, such as the site of application in/to the body, structural feature, technical feature or material composition. The site of application in/to the body refers to parts of the human body where the product is applied to, which can be a human system, organ, tissue or cells. The structural feature is a description of the specific structure and appearance of the product. The technical feature is a description or limitation of the special functional principle, mechanism or special property of the product. The material composition is a description of the main material or main component of the product.

Article 7 In addition to conforming to Article 6 of the Rules, generic names of medical devices shall not contain the following contents:

(1) Model or specifications;

(2) Graphics, symbols, etc.;

(3) Names of a person or enterprise, registered trademarks or other similar names;

(4) Absolute and exclusive expressions such as “最佳”, “唯一”, “精确” or “速效”, and claims or assurances on the effectiveness of the products;

(5) Words describing the effectiveness and curative ratio;

(6) Unsubstantiated assumptions and conceptual terms that are not verified by science or clinical assessment.

(7) Words expressing or implying that the device can cure all diseases, exaggeration on the indications for use, or other misleading and deceptive contents;

(8) Exaggerated claims such as “美容” and “保健”;

(9) Other contents prohibited by relevant laws and regulations.

Article 8 The generic names of medical devices shall not be registered as trademarks in accordance with Paragraph 1, Article 11 of the Trademark Law of the People's Republic of China.

Article 9 The naming of in-vitro diagnostic reagents which are regulated as medical devices shall comply with the Provisions for In-Vitro Diagnostic Reagent Registration (Decree No.5 of China Food and Drug Administration).

Article 10 The Rules shall be effective as of April 1, 2016.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.