Posted in NEWS, NEWS on implant administration

India To Regulate All Medical Devices

25 March 2020

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 R	MED DEVICE Online 25.03.2020
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