Overview of current Regulations governing Medical Devices
Abstract
Medical Device (MD) is one of the fastest growing sector and so are the associated regulations. From lack of even policies and guidelines to stringent MD legislations in others, the requirements vary across countries. Understanding and interpreting the global MD evolving regulations and requirements is important (for not just the manufacturers, importers, wholesalers and distributors but even the clinicians) in the current global competitive market. This review is an attempt to do that by giving an overview of the prevailing MD regulations in United States (U.S), Europe and India.
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References
2. Bansal A, Shukla V, Chauhan S, SP Y, Kumar S, katrolia A. Drug regulatory paradigm and challenges for Medical devices in India. International Journal of Drug Regulatory Affairs [Internet]. 16Mar.2019 [cited 14 Mar 2019];7(1):25-3. Available from:
https://ijdra.com/index.php/journal/article/view/299
3. Judith AJ. FDA regulation of medical device. Congressional Research Service. R42130; 2016.
4. Gail AVN. Drugs, Devices, and the FDA: Part 2: An overview of approval processes: FDA approval of medical devices. JACC: Basic to Translational Science. 2016 Jun; 1(4):277-287
5. Bobby G. Acting on Medical Devices. In: The Act that Wasn’t® (Ed 3). India: Self-published. ISBN 978-93-84334-77-2; 2019 .p. 182-193.
6. Angelica L. FDA to overhaul more than 40-year-old process for approving medical devices that some say puts consumers at risk. CNBC, Health Sciences; 2018 Nov 26.
7. Jeff S., CDRH FY 2019 Proposed Guidance Development and Retrospective Review [Internet]. FDA; 2018 Oct 03 [cited 2019 Mar 23]. Available from: https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm622446.htm
8. Bobby G. Registration of Medical Devices. Perspectives in Clinical. Research. 2010 Jul-Sep; 1(3):90-93.
9. EU Commission press release [Internet]. European Commission; 2019 [cited 2019 Mar 21]. Available from:
https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#new_regulations
10. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices; 2017.
11. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices; 2017
12. Europe braces for harder times in medical device innovation while US FDA eases regulations. Vascular news; 2018 Jun 08.
13. Deloitte. Preparing for the future: The new European Union medical devices regulation; 2019
14. GSR. 78 (E). Indian Medical Devices Rules 2017 published by the Central government under the Ministry of Health and Family Welfare; 2017 Jan 31.
15. CDSCO Notice No. 29/Misc./3/2017-DC(292). Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules; 2017 Nov. 01.
16. CDSCO to hire 754 Regulatory Officers especially to regulate Medical Devices in country: DTAB; 2019 28 Apr.
17. World Health Organization. Medical Device regulations. Global overview and guiding principles. WHO, Geneva; 2003.
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