Gunjan Verma - India

“So many applications were submitted right at the October 1st deadline that the CDSCO needs more time to clear the backlog.”

Gunjan Verma
Managing Partner
Asia Actual India

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India Extends Deadline for Class C and D Import Licenses

Published on: May 28th, 2024

Importation Extension

On May 16th, 2024 the Central Drugs Standard Control Organization’s (CDSCO) published a circular that extends allowances for importation of unregistered Class C and D Medical Devices with applications already under CDSCO review. Following representations from Industry Associations and Stakeholders, and amid concerns about business continuity during this transition, The Ministry of Health & Family Welfare (MoHFW) has decided that importers or manufacturers who had applied for licensing before September 30th, 2023 would be allowed to continue importing or manufacturing Class C or D devices for up to three months from the date of issuance of the order (i.e. likely 15 August 2024) or until a decision is made on their application by the Central Licensing Authority, whichever comes first. 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 unregistered products with a pending Import License application. The deadline before the extension announced on May 16th was April 1st, 2024 and is now around mid-August.

Medical Device Regulations in India have under gone many changes since 2017 when the CDSCO published the New Medical Device Rules that implicated lots of devices which wouldn’t have been required to register prior. August will mark the end of a this importation grace period which will in turn mark the end of a 7 year long transition to the new Rule’s Medical Device Regulations in India.

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 in India and the rest of Asia.

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