CFDA issues Naming Rules for Medical Device Generic Name, Does your Product Measure Up?

Dec 23^th, 2015, CFDA has issued the Naming Rules for Medical Device Generic Name (CFDA Order No. 19 in 2015), which will come force as of April 1^st, 2016. Those Rules indicate that the product sold or used in China shall use the same generic name with the same/similar intended use or techniques.

1. How to name your product according to the New Rules?

1.1 Medical Device Common Name Composition:

Core Word: a summary description of medical devices with the same or similar techniques, constructions or intended uses;

Feature Word: a illustration of features of construction or techniques of the device, applied parts of human body or composition of materials, etc..
1.2 In Vitro Diagnostic Reagent Common Name Composition:

Naming of IVD reagents shall be complied with Administrative Measures for the Registration of In Vitro Diagnostic Reagents. If the measured substances have too many components or under special circumstances, the substance can adopt the indication name related to the product or other substitute names.

2. However the following content shall not be contained in the common name:

2.1 Type and Specification;

2.2 Graphics, Symbols, etc.;

2.3 Names such as personnel name, trade name, etc.;

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

2.5 Words which illustrate the effective/cure rate of the device;

2.6 Conceptual names which is hypothetical or without scientific proof or clinical evaluation;

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

2.8 Advertising words like “health” and “beauty” etc.;

2.9 Other words forbidden by laws or regulations.

The Common names of medical device shall not be registered as trademarks.

3. If your product's name does not conform to the Rules, you will face a series of problems in the future.

3.1 You will have troubles while registering your medical device while submitting your registration dossier after Apr 1^st2016.

3.2 You may be lucky to obtain the registration certificate for your medical device with unqualified name before Apr 1^st 2016, but you will face the problem of certificate alteration. Product name alteration is the Approval Alteration which charge the Administration Fee (Class II: 42,000 RMB; Class III: 50,400RMB).

3.3 If you apply for renewing your certificate which expires after Apr 1^st2016, you may meet the troubles due to qualified name. In this case, you can submit the Product name alteration application to CFDA while CFDA give you a Supplementary Notice. You also can submit the Product name alteration application and Certificate Renewal Application simultaneously.

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