India Extends Deadline for Class C and D Import Licenses

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.