This paper is published in Volume-3, Issue-4, 2017
Area
Drug Regulatory Affairs
Author
Pakala Jayasree
Co-authors
Jyothshna Devi .K, Alagusundaram. M, Jayachandra Reddy .P
Org/Univ
Pharmaceutics and Drug Regulatory Affairs, India
Pub. Date
28 July, 2017
Paper ID
V3I4-1251
Publisher
Keywords
Medical Device, GHTF, Regulatory Requirements, Harmonization.

Citationsacebook

IEEE
Pakala Jayasree, Jyothshna Devi .K, Alagusundaram. M, Jayachandra Reddy .P. Overview of Regulatory Guidelines for Medical Devices, International Journal of Advance Research, Ideas and Innovations in Technology, www.IJARIIT.com.

APA
Pakala Jayasree, Jyothshna Devi .K, Alagusundaram. M, Jayachandra Reddy .P (2017). Overview of Regulatory Guidelines for Medical Devices. International Journal of Advance Research, Ideas and Innovations in Technology, 3(4) www.IJARIIT.com.

MLA
Pakala Jayasree, Jyothshna Devi .K, Alagusundaram. M, Jayachandra Reddy .P. "Overview of Regulatory Guidelines for Medical Devices." International Journal of Advance Research, Ideas and Innovations in Technology 3.4 (2017). www.IJARIIT.com.

Abstract

Medical devices are becoming more important in the health care unit. Diversity and intricacy of medical devices in last two decades. Regulation of these devices has also advanced due to the requirement for a steady regulatory perspective. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. This thesis examines the regulatory requirements for medical devices in Australia, Brazil, India, Japan, Russia, MENA countries and compares them with the requirements in the European Union. The conclusion of this thesis is that most countries have similar requirements for registration of medical devices and are striving to harmonize with the GHTF guidelines. Now with the availability of different regula­tions of the countries or region on medical devices, there is a need to harmonize regulations in order to curtail regulatory hurdles and expedite access to high quality, safe and efficacious medical devices. Most coun­tries are trying to harmonize the regulatory guidelines for medical devices through their participation in Global Harmonization Task Force (GHTF). Harmonized regulation of medical device will lead to the availability of quality product.
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