ABSTRACT
Since in vitro diagnostic (IVD) kits are deemed to be drugs under the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945, regulatory guidelines need to be adhered to in order for these IVD kits to be sold in the market. There are two types of IVD kits accessible, depending on their use, namely notified and non-notified IVD kits, and the rules differ accordingly. A restricted number of IVD kits may be used for testing and personal purposes, according to the regulations. In vitro diagnostic (IVD) kit importation and reagent shipping both fall under the regulatory approval window. However, prior authorisation is required for both processes. In this chapter, the specifics of the approval procedure for IVD kits are analysed and discussed in further detail.
