India - Medical Devices Rules,2017 & Medical devices (Amendment) Rules 2020

The Indian Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health & Family Welfare (MoHFW) is the national regulatory authority for medical devices placed on the India market, based on Medical Devices Rules, 2017 and Medical Devices (Amendment) Rules 2020. Medical devices regulations primarily focus on the quality and safety control to ensure the highest quality assurance of a medical device. Classifications are made according to patient risk in 4 classes (Class A, B, C & D). Registration, application/submission of documents, testing, followed by audit/inspection that may be needed for certain class of medical device, is the process of obtaining the manufacturing license.

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 1 Jan,2021) 25. Blood Pressure Monitoring Device (effective from 1 Jan,2021) 26. Glucometer (effective from 1 Jan,2021) 27. Digital Thermometer (effective from 1 Jan,2021) 28. All implantable medical devices Equipment (effective from 1 April,2021) 29. CT Scan Equipment (effective from 1 April,2021) 30. MRI Equipment (effective from 1 April,2021) 31. Defibrillators (effective from 1 April,2021) 32. PET Equipment (effective from 1 April,2021) 33. X-Ray Machine (effective from 1 April,2021) 34. Dialysis Machine (effective from 1 April,2021) 35. Bone marrow cell separator (effective from 1 April,2021) 36. Disinfectants and insecticide specified in Medical Devices Rules, 2017 37. Ultrasound equipment (effective from 1 Nov, 2020)