Medical Network January 2 IVD manufacturers note that following the release of the new "Medical Device Classification Catalog," the State Administration of Drug Control re-issued a circular on the classification of in vitro diagnostic reagents products have also been adjusted.
In early September this year, the General Administration of Drug Administration openly released a new version of "medical instruments Catalog ", which will come into effect on August 1, 2018. However, this catalog does not include" 6840 IVDC Sub-Catalog (2013 Edition) "content and packagings.
On December 29, SFDA 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 .
New in vitro diagnostic reagents product attributes defined and classified as follows:
I. In Vitro Diagnostic Reagents Related to Allergies (Allergens), including Total IgE Test Reagents and Specific IgE Antibody Test Reagents, will be administered as a second category of medical devices.
Second, supporting the use of flow cytometry in vitro diagnostic reagents:
1, as the third type of products 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 a second type 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 first type of 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.
Third, immunohistochemistry and in situ hybridization in vitro diagnostic reagents:
1, as a third type 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.
2, as the first type 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.
Fourth, not in accordance with the medical device management products, including:
1, no clinical use of antibodies, probes and other reagents;
2, 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.
