India To Regulate All Medical Devices

Until recently, Indian regulations covered only 15 “notified” categories, such as syringes, needles, stents, and orthopedic implants; the rest of the market has been largely unregulated. Rules released in 2017 explained that more categories would get notified over time and, indeed, the number of notified categories is being expanded to 37 by April 2021.
Notified Device Categories

1. Disposable Hypodermic Syringes
2. Disposable Hypodermic Needles
3. Disposable Perfusion Sets
4. Substances used for in vitro diagnosis including Blood Grouping Sera
5. Cardiac Stents*
6. Drug Eluting Stents*
7. Catheters
8. Intra Ocular Lenses*
9. I.V. Cannulae
10. Bone Cements*
11. Heart Valves*
12. Scalp Vein Set
13. Orthopedic Implants*
14. Internal Prosthetic Replacements*
15. Ablation Devices
16. Ligatures, Sutures and Staplers
17. Intra Uterine Devices (Cu-T)
18. Condoms
19. Tubal Rings
20. Surgical Dressings
21. Umbilical tapes
22. Blood/Blood Component Bags
23. Organ Preservative Solution*
24. Nebulizer (effective from Jan. 1, 2021)
25. Blood Pressure Monitoring Device (effective from Jan. 1, 2021)
26. Glucometer (effective from Jan. 1, 2021)
27. Digital Thermometer (effective from Jan. 1, 2021)
28. All implantable medical devices Equipment (effective from April 1, 2021)*
29. CT Scan Equipment (effective from April 1, 2021)
30. MRI Equipment (effective from April 1, 2021)
31. Defibrillators (effective from April 1, 2021)
32. PET Equipment (effective from April 1, 2021)
33. X-Ray Machine (effective from April 1, 2021)
34. Dialysis Machine (effective from April 1, 2021)
35. Bone marrow cell separator (effective from April 1, 2021)*
36. Disinfectants and insecticide specified in Medical Devices Rules, 2017
37. Ultrasound equipment (effective from Nov. 1, 2020)

*bold marking of implants through Implant-Register®

Author(s)Source
Bagla G, Rohatgi RMED DEVICE Online 25.03.2020
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