How to name an in-vitro diagnostic reagent product

How are regular in-vitro diagnostic reagent products named?

In China, there are clear naming requirements for in-vitro diagnostic reagent products; they cannot be named arbitrarily. The naming of in-vitro diagnostic reagents should follow the following guidelines:

Product names can generally consist of three parts. Part 1: Name of the substance being measured; Part 2: Use, such as diagnostic serum, assay kit, quality control product, etc.; Part 3: Method or principle, such as enzyme-linked immunosorbent assay, colloidal gold method, etc. This part should be listed in parentheses.

If the measured substance has multiple components or other special circumstances, a name related to the product's indication or other alternative name can be used.

Class I products and calibrators and quality control products are named according to their intended use.

Do imported in-vitro diagnostic reagents require approval?

Imported Class I in-vitro diagnostic reagents are subject to record filing. Imported Class II and Class III in-vitro diagnostic reagents require approval before they can be marketed.

For record filing of imported Class I in-vitro diagnostic reagents, the filer submits the filing materials to the National Medical Products Administration (NMPA) and obtains a filing certificate.

Imported Class II and Class III in-vitro diagnostic reagents are inspected by the NMPA, and a medical device registration certificate is issued after approval.

The registration and filing of in-vitro diagnostic reagents from Hong Kong, Macao, and Taiwan are handled in accordance with the regulations for imported in-vitro diagnostic reagents.