In order to cooperate with the implementation of the administrative measures for the registration of in vitro diagnostic reagents (Order No. 5 of the State Food and Drug Administration), through the joint efforts of all parties, 19 varieties were added on the basis of the national standard and reference catalogue of in vitro diagnostic reagents for registration and inspection (phase I), and the original 7 restricted varieties were adjusted to normal supply varieties. 61 varieties will be announced as follows:

Note: 1* The marked variety is the reference material of in vitro diagnostic reagent added in this catalogue. ▲ the marked varieties are adjusted from the limited supply varieties in the previous catalogue to the normal supply varieties. 2. The electronic version of the instructions of relevant varieties can be found on the website of China Institute of food and drug control http://www.nifdc.org.cn/bzwz/CL0481/ , click directory query to browse online. 3. Restricted supply refers to the supply only to relevant in vitro diagnostic reagent manufacturers.

Reference materials and standardization management center

November 7, 2016