India’s Class C and D Import License Enforcement Deadline Fast-Approaching

Products With Pending Applications Could Face Importation Issues

On April 1, 2024, the Central Drugs Standard Control Organization’s (CDSCO) grace period for Non-Regulatory Class C and D medical devices in India comes to a close. This deadline is important for affected devices, but also for any devices with an active Import License application as the deadline has caused elevated workloads for regulators that result in longer processing timelines. So far this year there have been 342 risk class C and D Import License issued by the CDSCO. This number is up from 230 from the same period last year.

As a reminder, the grace period began September 30, 2023, for registered products with a pending Import License application.

Per the G.S.R 102 (E), published on February 11, 2020, all class C and D medical devices were to acquire an MD-15 Import License by October 1, 2023. However, similar to the Class A and B deadline, India’s CDSCO extended the grace period 6 months so manufacturers could continue the importation and marketing activities to ensure the medical device supply in India continues uninterrupted. Given that the grace period ends in a little over a month, manufacturers should ensure that their new Import License(s) have been or will soon be secured.