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All Class A and B Devices Require Import Licenses beginning October 1, 2022. Per the new Circular discussed here, manufacturers that have Registered their medical device on the ePortal and have submitted an Import License application on or before September 30, 2022 can continue importing for up to 6 months.
All Class C and D require an Import License by October 1, 2023 and Registration beforehand.
For the latest information on the regulatory process in India, please see our page on the topic here.
India Grants Import License Grace Period for Class A and B Devices
Published on: September 30th, 2022
Import License Grace Period Provides Manufacturers with an Additional 6 Months
Released on September 30, 2022, the Central Drugs Standard Control Organisation (CDSCO) issued Circular File No. 29/Misc/03/2022-DC (257) providing an Import License grace period to all Non-Regulatory Class A and B medical devices. This comes 1 day before the October 1st deadline outlined in G.S.R. 102 (E) where all Class A and B medical devices must have an Import License prior to importation into India.
This Import License grace period will ensure that Non-Regulatory Class A and B medical devices currently Registered and with a pending Import License application as of September 30, 2022 can still be imported and marketed for another 6 months while their applications are reviewed.
Per the new Circular:
In view of the above (requests from various Associations and Stakeholders), it has been decided that, in case, if an existing importer/manufacturer who is already importing /manufacturing any of Class A or Class B Medical Devices, has submitted application to Central Licensing Authority or State Licensing Authority on or before 30.09.2022, as the case may be, for grant of import /manufacturing licence in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from the date of issue of this order or till the time, the Central Licensing Authority or State Licensing Authority, as the case may be, takes a decision on the said application, whichever is earlier.
As stated in G.S.R. 102 (E), released on February 11, 2020, all Class A and B medical devices were to be under the licensing regime beginning October 1, 2022. However, this grace period provides manufacturers with additional time to obtain their Import License(s) and ensures there is no interruption to the medical device supply in India.
Upcoming Class C and D Import License Requirements
Also outlined in G.S.R. 102 (E), all remaining Non-Regulatory Class C and D devices must have an Import License by October 1, 2023. Before then, manufacturers must Register their Class C and D devices on the online portal. Once the below informaiton has been submitted, a Registration number will be issued immediately.
Information required for Class C and D Registration before October 1, 2023.
- Generic Name
- Model No.
- Intended Use
- Class of Medical device
- Material of Construction
- Dimension (if any)
- Shelf Life
- Sterile or Non Sterile
- Brand Name (if registered under the Trade Marks Act, 1999)
Manufacturers of Non-Regulatory Class C and D devices interested in marketing their device(s) in India should Register their product immediately and begin preparing Device Master File(s) for submission before the end of the 2022. Given 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 and a full list of Regulatory devices, 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.