Requirements for introducing Medical devices in India and US market - A comparative study of regulations

  • Vijaya Ratna Jayanti retired as Professor from AU College of Pharmaceutical Sciences, Andhra University, Visakhapatnam
  • Parimalambica Madisi
  • Kolapalli Venkata Ramana Murthy


Medical devices are widely used in the healthcare sector and are manufactured by the pharmaceutical industry.The Government of India has periodically come out with certain guidelines, to be followed by the companies, manufacturing medical devices. There are some challenges which have to do with the medical devices.  They are designed by manufacturers in answer to the demands and expectations of doctors, are appraised by doctors and are used in patients. Phase I trials are not possible for them as they cannot be tested on healthy volunteers. Adverse Drug Reactions are not detected in medical devices as easily as for medicines. There are no separate regulations (apart from Schedule M III of Drugs and Cosmetics Act) for Medical Devices in Indiabefore 2017. U.S. FDA has robust regulations for medical devices. If any company wants to market its medical device in the U.S.A, it should be proved to be substantially equivalent to a chosen predicate device that is already there in the market in the USA. This paper studies the current scenario in India and the USAregarding regulations concerning medical devices. It concludes that India cannot have a policy of “accept in India if it is accepted abroad”. Acceptance requirement should include certification from Notified Technical Bodies of India. India should have better connectivity between regulators and doctors as far as medical devices are concerned. A National Registry should be developed for each variety of Class D medical devices, such that “recall action”, if necessary, can be taken in a fast and systematic manner.



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1. Global Medical Device Market Outlook [Internet]. 2018 [cited 2018 May]. Available from:
2. Goldberger BA. The evolution of substantial equivalence in FDA's premarket review of medical devices. Food & Drug LJ. 2001; 56:317.
3. U.S. Food and Drug Administration Over view of device regulations [Internet].; 2018 [cited 2018 Aug 31]. Available from:
4. U.S. Food and Drug Administration Premarket notification 510(k) [Internet].; 2018 [cited 2018 Sept 27]. Available from:
5. U.S. Food and Drug Administration. PMA Approvals [Internet].; 2018 [cited 2018 Aug 23]. Available from:
6. U.S. Food and Drug Administration [Internet].; 2018 [cited 2018 Sept 27]. Available from:
7. Bhatt P, Lalani R, Vhora I, Patil S, Amrutiya J, Misra A, Mashru R. Liposomes encapsulating native and cyclodextrin enclosed Paclitaxel: Enhanced loading efficiency and its pharmacokinetic evaluation. International Journal of Pharmaceutics. 2018; 536(1):95-107.
8. Patel JK, Amrutiya J, Priyanka B., Javia A, Jain M, Misra A. Targeted delivery of monoclonal antibody conjugated docetaxel loaded PLGA nanoparticles into EGFR overexpressed lung tumor cells. Journal of Microencapsulation. 2018; 35(2):204-17.
9. U.S. Food and Drug Administration The new 501(k) paradigm [Internet].; 2018 [cited 2018 Mar 13]. Available from:
10. Shapiro JK. Substantial Equivalence Premarket Review: The Right Approach for Most Medical Devices. Food & Drug LJ. 2014; 69:365.
11. Radhadevi N, Balamuralidhara V, Kumar TM, Ravi V. Regulatory guidelines for medical devices in India: An overview. Asian J Pharm. 2014 Aug 23; 6(1).
12. A guidance document for medical devices draft version 2018 Indian Pharmacopoeia Commission [Internet]. CDSCO [cited 2018 Aug 19]. Available from:
13. CDSCO guideline on Medical devices and diagnosis [Internet]. CDSCO; 2018 [cited 2018 Jun 13]. Available from:
14. Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017 [Internet].CDSCO: New Delhi; 2017 [cited 2018 Aug 20]. Available from:
15. The Hindu newspaper [Internet]. 2018 Sept 15 [cited 2018 Sept 15]. Available from:
16. The Hindu newspaper [Internet]. 2018 Sept 16 [cited 2018 Sept 16]. Available from:
17. The Hindu newspaper [Internet]. 2018 Oct 06 [cited 2018 Oct 6]. Available from:
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How to Cite
Jayanti, V. R., P. Madisi, and K. V. Murthy. “Requirements for Introducing Medical Devices in India and US Market - A Comparative Study of Regulations”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 4, Dec. 2018, pp. 9-20, doi: