Regulatory Affairs

India Offers Guidance to Speed Review of IVD Registrations

The Central Drugs Standard Control Organization has issued detailed guidance on the registration, reregistration and import of notified in vitro diagnostic kits and on the import of non-notified kits, with the aim of speeding submission reviews and easing the move to electronic submissions. Read More

India Offers Detailed Guidance on Registration, Import of IVDs

Manufacturers looking to register devices in India will have to take into account a detailed guidance issued by India’s Central Drugs Standard Control Organization on submission requirements for the registration, reregistration and import of certain diagnostic kits. Read More