Naming Rules for Medical Device Generic Name

Article I

In order to strengthen the supervision and administration of medical device, and ensure medical device named scientifically and normally. CFDA formulates these Rules according to Regulations for the Supervision and Administration of Medical Devices.

Article II 

The generic name of medical device sold and used within the territory of the People’s Republic of China shall comply with these Rules.

Article III 

The generic names of medical device shall comply with the relevant laws and regulations of the state. The generic name shall be scientific and clear, that consistent with the real property of medical device.

Article IV

The generic name of medical device shall be named by Chinese and conform to the state language specification.

Article V 

The same variety of medical device with same or similar intended use or technology shall use the same generic name.

Article VI 

The generic name of medical device consists of one core word and less than three feature words.

Core word refers to the general statement of medical device with same or similar technology, composition, intended use.

Feature word refers to the statement of specific properties of medical device, such as used location, structural features, technological feature, and material composition. Used location refers to the site of action which can be human body system, organs, tissues, cell, etc.. Structural feature refers to the description of specific structure and appearance. Technological feature refers to the introductions or limitation of special principle/mechanism or special performances. Material composition refers to the description of main materials or main ingredients.

Article VII

The generic name of medical device shall not contain the following content: 

(1)       Type and Specification;

(2)       Graphics, Symbols, etc.;

(3)       Names such as personnel name, trade name, etc.;

(4)       Absolute and exclusive words such as Best, Unique, Accurate, Quick-acting, or other word which can avert or guarantee the efficacy of the device;

(5)       Words which illustrate the effective/cure rate of the device;

(6)       Conceptual names which is hypothetical or without scientific proof or clinical evaluation;

(7)       Words express/imply that the device are applicable for every disease or exaggerate the application scope of the device, other misleading or deceptive words;

(8)       Advertising words like “health” and “beauty” etc.;

(9)       Other words forbidden by laws or regulations.

Article VIII 

The generic name of medical device shall not be registered as trademarks according to the PRC Trademark Law.

Article IX

In vitro diagnostic reagent which managed as medical device shall be named according Administrative Measures for the Registration of In Vitro Diagnostic Reagents

Article X

These rules shall take effect on Apr 1st, 2015.