Market Authorization of Medical Devices in India

Definition of Medical Devices:

According to the Drug and Cosmetics Act (DCA), a medical devices are categorized as a drugs and defined as, “Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board” [1].

List of Notified Medical Devices:

1. Disposable Hypodermic Syringes

2. Disposable Hypodermic Needles

3. Disposable Perfusion sets

4. IVD Devices for HIV, HBsAg and HCV

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

Additional Products:

15. Blood Grouping Sera

16. Ligatures

17. Sutures

18. Staples

19. Intra Uterine Devices (Cu-T)

20. Condoms

21. Tubal Rings

22. Surgical Dressing

23. Umbilical Tapes

24. Blood/Blood Component Bags.

Regulatory Pathway:

References:

[1] The Drugs And Cosmetics Act And Rules, Department of Health, Government of India

[2] Guidance Document - Requirements for Conducting Clinical Trial(s) of Medical Devices in India

[3] Guidance document on application for grant of Licence in Form-28 for manufacture of Medical Devices in India under CLAA Scheme

[4] Schedule M-III_GMP for Medical Devices