2018 CFDA Changes in IVD Product Classification

On December 29th 2017, CFDA issued Circular No. 226 of 2017, redefining the attributes and categories of IV diagnostic reagent products such as allergens, FACS, immunohistochemistry and in situ hybridization.

This round of major IVD classification updates include:

1. In Vitro Diagnostic Reagents Related to Allergies (Allergens), including Total IgE Test Reagents and Specific IgE Antibody Test Reagents, will be administered as a Class I of medical devices.

1. Supporting the use of flow cytometry in vitro diagnostic reagents:
   1. As the Class III of products for in vitro diagnostic reagents management, will include: to guide clinical drug antibody reagents; lymphocyte subsets analysis kit; with a clear diagnostic value of the antibody reagent.
      
   2. As the Class II of products for in vitro diagnostic reagents management, including: universal counting reagents for flow cytometry (counting tubes, counting microspheres), reagent setting conditions (fluorescence compensation microspheres) and so on.
      
   3. As the Class I of products for in vitro diagnostic reagents management products, including: with diagnostic value of ancillary reagents; flow cytometry sample processing reagents (hemolysin, buffer, fixative, rupture agent, sheath fluid, etc.) Control antibody reagents and combinations thereof.

1. Immunohistochemistry and in situ hybridization in vitro diagnostic reagents:
   1. As the Class III of products managed in vitro diagnostic reagents, including: specific antibodies or probe reagents to guide clinical medication; antibodies or probe reagents with a clear diagnostic value.

1. 1. As the Class I of in vitro diagnostic reagents management products, including: with diagnostic value of the antibody or probe reagent; staining solution; immunohistochemistry and in situ hybridization sample processing reagents, reaction system reagents.

1. Not subject to CFDA medical device management, including:
   1. Non-clinical use of antibodies, probes and other reagents;

1. 1. Equipment cleaning, maintenance, maintenance, debugging reagents (laser, voltage calibration microspheres) and so on.

According to the circular, the new IVDC product management category will come into effect on March 1, 2018.