India Issues Guidelines on Grouping Devices for Licensing

India’s Ministry of Health and Family Welfare released guidelines for grouping medical devices into a single application for importing, manufacturing or distributing medical devices in India.

Applicants who want to license, import or manufacture a device may group similar devices in a single application. The ministry said the applications could include devices that have similar intended purposes or common technology.

A single medical device is one that that is sold as a distinct packaged entity and doesn’t meet the criteria for a family of devices such as an in vitro diagnostic test kit, IVD cluster or a group.