The CFDA sought comments on the Medical Device Naming Rules (Trial).

In order to strengthen the supervision and management of medical devices and ensure the scientific and standardized naming of medical devices, in accordance with the Regulations on the Supervision and Administration of Medical Devices, the State Administration of Food and Drug Administration has drafted the Rules for the Naming of Medical Devices (Trial) (draft for comments), and is now open to the public for comments. Relevant units and the public can provide feedback through the following channels and methods:
1. Log on to the Chinese Government Legal Information Network to enter the "Draft Department Regulations Collection System" on the left side of the home page.
2. Send your opinions by letter to the 2nd floor of the 26th House (postcode 100053) of Xuanwumenxi Street, Xicheng District, Beijing, and indicate the words "Medical Device Naming Rules" on the envelope for comments.
. E-mail comments to:
xuxy@cfda.gov.cn
, please indicate the words "Medical Device Naming Rules for Comments".
4. Fax your comments to: 010-63098758.
feedback is due on August 12, 2015.
State Food and Drug Administration
July 10, 2015
Medical Device Naming Rules (Trial) (Draft for Comments)
Article 1 These Rules are formulated in accordance with the Regulations on Medical Devices Supervision and Administration in order to strengthen the supervision and management of medical devices and ensure the scientific and standardized naming of medical devices.
The naming of the generic names of medical device products sold and used within the territory of the People's Republic of China shall comply with these Rules.
Article 3 The generic name of a medical device shall comply with the relevant laws and regulations of the State and shall be consistent with the true attributes of the product, scientific and clear, and shall not mislead or deceive the user.
the general name of medical devices shall be used and shall Chinese in accordance with the national language and written norms.
the same generic name for medical devices of the same variety. A generic name consists of one core word and generally no more than three feature words.
6 of this article is the most general expression of medical devices with the same or similar technical principles, structural composition, performance indicators and intended use.
7 characteristics are a description of the main features such as the use site, structural characteristics, technical characteristics, material composition and specific attributes of medical devices.
use refers to the main functional action object or point of action of the product, which can be the whole or part of the human body, tissue, structure, organ.
structure is characterized by a description of the product-specific structure and appearance.
technology is characterized by a description or qualification of the principle or concept of the special action of the product.
material composition is a description of the main material of the product.
specific attributes are a qualified description of some of the special performance of the product.
the general name of a medical device shall not contain the following:
(1) model or specification;
(2) graphics, symbols and other signs;
(3) the name of the person, the name of the enterprise, the name of the brand, the name of the trademark or other similar names;
words such as "best", "latest", "unique", "precise" and "quick-acting" in the same way;
(v) words expressing or implying a therapeutic effect on a disease, or containing assertions or guarantees indicating efficacy, efficiency and cure rate;
(vi) express or imply the content of treating a hundred diseases, adapting to all symptoms or exaggerating indications, or containing "beauty", "health care" and other propaganda content;
(vii) the conceptual name that has not been scientifically proven or clinically proven, or that is nihil and hypothetical;
(8) Other contents prohibited by relevant laws and regulations.
9 the generic name of a medical device may not be registered as a trademark.
article 10 shall be carried out in accordance with the general name of the in-body diagnostic reagents administered by medical devices in accordance with the relevant provisions of the in-body diagnostic reagents.
11th Rules shall come into effect on X-June 2015.