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

Successful export to India with services according to the Indian CDSCO

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.

Detailed Information

Technical aspects	Safety
Market surveillance	Conditionally
Obligation	Mandatory
Factory inspection	Yes
Sample testing	No
Validity	Validity of licence: 5 years / Validity of registration: 5 years

Product Scope

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)

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