All IVD equipment and related instruments, analyzers, and software is now being transitioned to require registration in India under the Medical Device Rules, 2017, joining IVD reagents and kits which have been regulated since January 1, 2018, if not before.

These IVD products should be registered under the voluntary registration portal prior to October 1, 2021 and then obtain an Import License before October 1, 2022, or October 1, 2023, depending on the product’s risk classification.

In preparation for the new process, the Central Drugs Standard Control Organization (CDSCO) published a list of IVD analyzers, instruments and software with proposed risk classification by device type. A copy of the document is available here.

Manufacturers should review the proposed classification for their devices and work with their India Agent to provide feedback to the CDSCO on any perceived discrepancies in IVD device classification with a deadline of October 2, 2020.

Contact Asia Actual with questions or for regulatory support in India.