Import Licensing Requirement

With the release of Order – F. No. 29/Misc/03/2021-DC (28) on Nov 3, 2021, CDSCO has postponed the Import Licensing requirement for 8 categories of medical devices, listed below. Importers and manufacturers of these devices now have until June 30, 2022 to be registered and include Import License information on labeling thereafter.  The original deadline established under the Gazette Notification S.O. 775(E), Feb 8, 2019, was April 1, 2021; and had already been extended once to October 17, 2021.

1. All Implantable Medical Devices,
2. CT Scan Equipment,
3. MRI Equipment,
4. Defibrillators,
5. PET Equipment,
6. Dialysis Machines,
7. X-Ray Machines and
8. Bone Marrow Cell Separators

Important Dates for Manufacturers to Know

Context of the Decision

Stakeholders had requested more time from the CDSCO Authority to comply with the regulatory requirements for import/manufacture license applications due to the current pandemic, citing that stopping the importation and manufacturing of these devices would have a major impact on the availability of crucial medical devices. To avoid any disruption in supply, the CDSCO, with approval from Ministry of Health and Family Welfare (MoHFW), has granted pardon only to the existing importers and manufacturers, and those who have already submitted their Import License applications to the CLA or SLA on or before April 18, 2021.

Existing importers and manufacturers that have already submitted their application can continue to import up to June 30, 2022, or until an Import License is issued, whichever is earlier. Meanwhile, the CLA and SLA will continue to review applications and issue import/manufacturing licenses.

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