A Comparative Study of Medical Device Regulation in US and India
Abstract
Articles, instruments, apparatuses, or machines used in the prevention, diagnosis, or treatment of illness or disease, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for some health purpose, make up the medical technology industry (commonly referred to as medical devices).
Medical supplies India's medical market is one of the top twenty in the world. By 2025, it is estimated to be valued $5.2 billion. India produces very little medical equipment and currently imports more than 70% of its medical supplies. In India, medical devices were governed by The D&C Act is a federal law that regulates the sale of drugs and cosmetic of 1940, which included specific medical device laws. India Medical Device Rules 2017, which are new medical regulations in India, were issued to fill this hole by the CDSCO. There are many doctors and pioneers in the field.
On the other hand, the United States continues to be the world's largest medical device market, with $156 billion in sales. It is estimated to reach $208 billion by 2023. In 2018, the United States exported $43 billion worth of medical equipment in key product categories specified by the Department of Commerce.
Downloads
References
2. Charlesworth M. and Zundert A A J Van. Medical device regulation: the need for clinical vigilance and oversight. 2019 Jun; 74(6):693-695.
doi: 10.1111/anae.14603. Epub 2019 Feb 21.
3. Sharma, D. and A. Chandra. Medical Device Rules-2017, India: An Insight. Applied Clinical Research, Clinical Trials and Regulatory Affairs. 2020;7(2): 126-34.
4. Faris, O. and J. Shuren. An FDA viewpoint on unique considerations for medical-device clinical trials. New England Journal of Medicine. 2017; 376(14):1350-57.
5. Manu M. and G. Anand. A review of medical device regulations in India, comparison with European Union and way-ahead. Perspectives in Clinical Research. 2022;13(1):3.
6. Gupta P et al. Medical device vigilance systems: India, US, UK, and Australia. Medical Devices (Auckland, NZ). 2010;3:67.
7. Dang A, Sharma JK. Economics of medical devices in India. Value in health regional issues. 2019;18: 14-17.
8. Maak TG and Wylie JD. Medical device regulation: a comparison of the United States and the European Union. Journal of the American Academy of Orthopaedic Surgeons. 2016;24(8):537-43.
9. Sorenson C and Drummond M. Improving medical device regulation: the United States and Europe in perspective. The Milbank Quarterly. 2014;92(1): 114-150.
10. Yaeger KA et al. United States regulatory approval of medical devices and software applications enhanced by artificial intelligence. Health Policy and Technology. 2019;8(2):192-97.
11. Pietzsch JB et al. Review of US Medical Device Regulation. Journal of Medical Devices. 2007;1: 283.
12. McAllister P and Jeswiet J. Medical device regulation for manufacturers. Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine. 2003; 217(6):459-67.
13. Rice L. Medical Device Establishment Registration Master File [Internet].1987[cited 2022 Feb 12]. Available from:
https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=Rice%2C+L.+%281987%29.+%22Medical+Device+Establishment+Registration+Master+File.%22+%09&btnG=
14. Monsein LH. Primer on medical device regulation. Part I. History and background. Radiology [Internet]. Radiology; 1997 oct [cited1997Oct01]. Available from Radilogy:
https://doi.org/10.1148/radiology.205.1.9314952

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM