Gunjan Verma - India

“After the voluntary period ends on October 2021, all class A and B non-regulatory medical devices will have 12 months to obtain an Import License, and Class C and D devices will have 24 months to meet the same requirement.”

Gunjan Verma
Managing Partner
Asia Actual India

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India Announces New Notified Medical Devices Requiring Import License

Published on: June 14th, 2021

All Implantable Devices, MRI and CT Scan Equipment Now Require Import Licenses

With the release of F. No. 29/Misc/03/2021-DC (28) on April 18th, 2021 the Central Drugs Standard Control Organization (CDSCO) now requires the following medical devices obtain an Import License prior to importation:

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

Grace Period

Manufacturers and/or importers that already import the newly notified devices and have applied for a manufacturing/import license can continue to import for up to 6 months or until approval is granted for the submitted application, whichever is earlier.

Regulatory Transition Summary

Medical devices submitted under the new voluntary rules are referred to as “Non-Regulatory Medical Devices”. The registration process will generate a file number the same day and must be included on the label prior to marketing.

After the voluntary period ends on October 2021, all class A and B non-regulatory medical devices will have 12 months (i.e., by October 1st, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1st, 2023) to meet the same requirement. For more information on the regulatory process, please see our webpage on medical device registration in India. Please click here for the latest information on the medical device registration requirements in India.

Complete List of Notified Devices

  1. Disposable Hypodermic Syringes
  2. Disposable Hypodermic Needles
  3. Disposable Perfusion Sets
  4. IVD Devices for HIV, HBsAg, HCV
  5. Cardiac Stents
  6. Drug Eluting Stents
  7. Catheters
  8. Intra Ocular Lenses
  9. V. Cannulae
  10. Bone Cements
  11. Heart Valves
  12. Scalp Vein Set
  13. Orthopaedic Implants
  14. Internal Prosthetic Replacements
  15. Blood Grouping Sera
  16. Ligatures, Sutures and Staplers
  17. Intra Uterine Devices (CuT)
  18. Condoms
  19. Tubal Rings
  20. Surgical Dressings
  21. Umbilical tapes
  22. Blood/Blood Component Bags
  23. Ablation Devices
  24. Organ Preservation Solution
  25. Blood Pressure Monitors (Effective January 1st, 2021)
  26. Digital Thermometers (Effective January 1st, 2021)
  27. Glucometers (Effective January 1st, 2021)
  28. Nebulizers (Effective January 1st, 2021)
  29. X-Ray Machines (Effective April 1st, 2021)
  30. CT Scan Equipment (Effective April 1st, 2021)
  31. MRI Equipment (Effective April 1st, 2021)
  32. PET Equipment (Effective April 1st, 2021)
  33. Defibrillators (Effective April 1st, 2021)
  34. Dialysis Machines (Effective April 1st, 2021)
  35. Bone Marrow Cell Separators (Effective April 1st, 2021)
  36. All Implantable Medical Devices (Effective April 1st, 2021)
  37. Ultrasound Devices (November 1st, 2021)
  38. Disinfectants and insecticides specified in Medical Device Rules, 2017

Grow With Us

Asia Actual is available to help navigate the complex medical device registration requirements and regulatory pathway for medical device and IVD distribution in India.

Contact Asia Actual for a free consultation to discuss the potential of your medical device or IVD in the Indian medical market.

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