Rules for Common Names of Medical Devices

Based on the nomenclature regulation of the medical device, all medical device sold and used in China shall use the Chinese name, other foreign language can be used if necessary. And when you name your product, you must use the common name, the same kind of device must use the same common name.

Your device name shall consist of one core word and no more than three characteristic words, where the core word is the general description for your device and may cover the technical mechanism, structural constitute, property standards or intended use. The characteristic words are responsible for describing the targeted parts, structure characteristic, technical feature, material composition, specific properties etc.

The name of your device must be scientific, explicit and brief, and cannot contain the model or standard of your product. The people name, corporation information, and brand cannot be included in your device name as well. Terms such as “best, latest, unique, accurate, quick-acting etc.” are not allowed to be used.

Here is the official explaination on "Rules for Common Names of Medical Devices"

There are ten articles in the "Rules", which mainly include the following aspects:

1. The legislative basis of the "Rules" is the "Regulations on the Supervision and Administration of Medical Devices", and the scope of application is the medical device products marketed and used in my country. The target of the regulation is medical devices. Generic name.

2. The principles to be followed in the naming of the generic names of medical devices should be legal, scientific, clear, and true, and should be in Chinese, and comply with the national language standards.

3. The content requirements and composition structure of the generic name. Medical devices of the same type with the same or similar intended purpose and common technology should use the same generic name; the generic name consists of a core word and generally no more than three characteristic words. And the content of core words and characteristic words are explained.

4. The prohibited content of the generic name, the generic name shall not contain "model, specification", "graphics, symbols and other signs", "personal name, company name, registered trademark or other similar names, except for the corresponding requirements specified in the Rules" 9 prohibitive requirements such as "the best, unique, precise, quick-acting and other absolute and exclusive words", and "the terms describing the effectiveness and cure rate".

5. Generic names shall not be registered as trademarks;

For more informations, please contact Edwin Wen for further assistant:

Email address: Edwin.wen@cirs-group.com