Gunjan Verma - India

“This Order Affects All Implantable Medical Devices, CT/MR/PET/X-Ray Equipment, Defibrillators, Dialysis Machines, and Bone Marrow Cell Separators.”

Gunjan Verma
Managing Partner
Asia Actual India

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India Postpones Registration Requirements for Certain Medical Devices

Published on: November 17th, 2021

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

Date to Remember Action to be Taken
March 31, 2022 Any applicant for the aforementioned medical devices, who has submitted an incomplete application on or before April 18, 2021, now needs to submit the missing documents in compliance to the requirements of the Medical Device Rules, 2017 by March 31, 2022.
June 30, 2022 Existing importers and/or manufacturers who have already submitted their applications to the Central License Authority (CLA) (for importation) or the SLA (for local manufacturing) can continue to import and/or manufacture the noted medical device(s) up to June 30, 2022, or until the time which license approval is granted for the submitted application, whichever is earlier.
June 30, 2022 As per the current order, importers and/or manufacturers must obtain an import or manufacturing license by or before June 30, 2022.
July 1, 2022 It is mandated for the importers and/or manufacturers to print the import/manufacturing license number on the device label from July 1, 2022 onwards.

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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