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 18^th, 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 1^st, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1^st, 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 1^st, 2021)
26. Digital Thermometers (Effective January 1^st, 2021)
27. Glucometers (Effective January 1^st, 2021)
28. Nebulizers (Effective January 1^st, 2021)
29. X-Ray Machines (Effective April 1^st, 2021)
30. CT Scan Equipment (Effective April 1^st, 2021)
31. MRI Equipment (Effective April 1^st, 2021)
32. PET Equipment (Effective April 1^st, 2021)
33. Defibrillators (Effective April 1^st, 2021)
34. Dialysis Machines (Effective April 1^st, 2021)
35. Bone Marrow Cell Separators (Effective April 1^st, 2021)
36. All Implantable Medical Devices (Effective April 1^st, 2021)
37. Ultrasound Devices (November 1^st, 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.