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

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sources and Links

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.

Grow With Us

Asia Actual specializes in helping medical device manufacturers grow their sales in Asia and with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests in India.

Blog Posts

China to Accept Foreign Generated Test Reports

China’s NMPA created a registration route specifically for innovative medical devices called the Innovative Green Pathway in 2014 and is based on the CFDA Order No. 13 2014. Since this registration route tends to cause some confusion, specific clarifying details are provided.

India Postpones Registration Requirements for Certain Medical Devices

With the release of a new order on Nov 3, 2021, CDSCO has postponed the Import Licensing requirement for 8 categories of medical devices.

VietNam Releases New Medical Devices Regulations

The MOH officially released Decree 98/2021 ND-CP, which implements significant new changes to the medical device regulations in VietNam.