How To Fill In The Information About The Main Raw Material Suppliers In The Appendix To The Product Technical Requirements For IVD Reagents?
2023-03-10
The suppliers of the main raw materials should be mentioned in the appendix to the product technical requirements. For external suppliers, they should be the manufacturers of raw materials which are mentioned in the product technical requirements, but not the distributors or agents. Correspondingly, the change of permission items for the suppliers of the main raw materials refers to the situation where the raw material itself has no change (for example, the clone of the antibody has no change) but only the manufacturer has changed.
