NMPA Finally Updates IVD Reagent Classification

On October 10, the NMPA (National Medical Products Administration) announced (No. 112 of 2020) an update to the product information of 29 IVD reagents in the 6840 Classified Subdirectory (2013 Version):
– A total of 29 reagent products (28 test reagents and 1 reagent for blood cell removal) were reclassified from class III to class II
– The product description / intended use of the 29 products were redefined
– The mentioned changes took effect on October 10 after the announcement

The 29 reclassified products include kappa light chain test kits, lambda light chain test kits, blood-derived cell removal reagents, and also test kits for tumors and cancer diseases.

Back in April 2020, the NMPA had already proposed the amendments of these 29 products, but made slight adjustments to the product descriptions after reviewing the comments from the public consultation. (Read our previous article about the draft proposal)

The current classification catalogue for IVD reagents dates to 2013. Therefore, NMPA’s recent release of the updated product information of 29 IVD reagents, primarily to down-classify from class III to class II, was long overdue.

 By Jacky Li. Contact Cisema if you would like to learn more.