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Applied Clinical Research, Clinical Trials and Regulatory Affairs


ISSN (Print): 2213-476X
ISSN (Online): 2213-4778

Review Article

Regulatory Requirements for Medical Devices: An Insight

Author(s): Onkar Bedi, Pawan Krishan and Gaaminepreet Singh

Volume 4, Issue 1, 2017

Page: [16 - 25] Pages: 10

DOI: 10.2174/2213476X03666160804153513

Price: $65


The medical device includes a variety of sophisticated, simple and newer equipments, such as tongue depressors, hemodialysis machines, PET (Positron emission tomography), MRI (Magnetic resonance imaging) scanners and magneto encephalography devices etc. The regulation of these devices has become advanced and more effective to produce continuous and steady regulatory perspective. There are different regulatory guidelines and organizations in this world for different countries such as, U.S.A., Europe, Japan, India, Australia and many others. These regulatory groups laboured together to provide excessive first-class, inexpensive merchandise with secure and appropriate use and disposal of scientific devices. The current review discusses the various life span phases of medical device, different approval steps of FDA for placing the medical device inside the market and the brief information associated with the various regulatory authorities with respect to different countries. Since the early 1980s, especially the regulatory requirements for medical devices have been improved. With the supply of various regulations of the international locations on clinical gadgets, there is a need to harmonize rules to be able to curtail regulatory hurdles and to provide best, safety and efficacious scientific devices. To accelerate international medical device regulatory harmonization and convergence, IMDRF (International medical device regulators from) group has been constituted which has come together to build the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) around the world.

Keywords: Medical device, regulatory guidelines, postmarket surveillance, CDSCO, GHTF and PMDA.

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