Gunjan Verma - India

“Manufacturers will need to have import licenses for all Class C and D medical devices before the beginning of April to successfully import their products.”

Gunjan Verma
Managing Partner
Asia Actual India

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

Published on: February 21st, 2024

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.

More Class C and D Import License Information

Given that Class C and D devices are high risk, the CDSCO’s review typically requires 6 to 9 months but could require more time should the device be selected for a Subject Expert Committee.

To learn more about registering medical devices in India, please see our page on the topic here.

To learn more about Subject Expert Committees and/or registering innovative medical devices in India, please see our article on the topic here.

Come Grow With Us

Please contact us if you’d like support from our experienced staff registering your device in India. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

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