Gunjan Verma - India

“It is expected that the CDSCO will continue implementing additional Notified devices in April as planned.”

Gunjan Verma, Asia Actual India

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India’s CDSCO Extends List of Notified Devices

Published on: January 13th, 2021

Import Licenses Now Required for Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers

With the release of File No.:29/Misc./03/2020-DC (297), on December 28th, 2020, the Central Drugs Standard Control Organization (CDSCO) now requires Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers obtain Import Licenses prior to marketing. There are now 28 Notified product categories that require Import Licenses while all others can register voluntarily until October 1st, 2021.

Grace Period

For manufacturers and/or importers who have already applied for manufacturing/ import license for any of these devices before December 27th, 2019 (Release of Notification for Extension of the Implementation- S.O. 4671(E)), applications shall be considered valid by the CDSCO. They can continue to import up to 6 months from issue of this order (i.e., up to June 28th, 2021) or until approval is granted for the submitted application, whichever is earlier.

Local manufacturers and importers who have not yet applied for a manufacturing/ import license cannot release or import devices as of January 1st, 2021.

More Devices Expected to Become Notified in April

Given that the release of this order is on schedule, it is expected that the CDSCO will continue implementing additional Notified devices in April as planned.

It is recommended that manufacturers of the below product categories submit applications for Import Licenses immediately to ensure market access is not interrupted. The following items have a deadline of April 1st, 2021:

1.     X-Ray Machines

2.     CT Scan Equipment

3.     MRI Equipment

4.     PET Equipment

5.     Defibrillators

6.     Dialysis Machines

7.     Bone Marrow Cell Separators

8.     All Implantable Medical Devices

Note: Ultrasound devices will then likely require Import Licenses beginning November 1st, 2021.

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.

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.

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 (April 1st, 2021)
  30. CT Scan Equipment (April 1st, 2021)
  31. MRI Equipment (April 1st, 2021)
  32. PET Equipment (April 1st, 2021)
  33. Defibrillators (April 1st, 2021)
  34. Dialysis Machines (April 1st, 2021)
  35. Bone Marrow Cell Separators (April 1st, 2021)
  36. All Implantable Medical Devices (April 1st, 2021)
  37. Ultrasound Devices (November 1st, 2021)
  38. Disinfectants and insecticides specified in Medical Device Rules, 2017

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