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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

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IJPR included in UGC-Approved List of Journals - Ref. No. is SL. No. 4812 & J. No. 63703

Published by : Advanced Scientific Research
ISSN
0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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REGULATORY REQUIREMENTS AND APPROVAL PROCESS FOR MEDICAL DEVICE IN JAPAN, AUSTRALIA AND BRAZIL

Author: SRIDHAR S, BALAMURALIDARA V*, RAVEENA NAIR, ABHISHEK B V
Abstract: Medical Device is the one of the biggest and fastest growing market in the healthcare industry and marketing the medical device in the country requires it specific regulatory requirements and approval process. The regulatory requirements and evaluation of the device depends upon which class of medical device does it belongs to. So the classification of medical device also varies with country to country. Most of the countries define the classification as per the risk based classification and the requirement of the device also depends upon the class-lower risk of device & lesser the documents required. If the risk of the device increases the data like clinical investigation and evaluation requirement for the approval also increase the approval time. So there should be mandatory i.e., post marketing surveillance should be done by the manufacturer to study the adverse events. Main goal is intend to learn about the data requirement and the regulatory approval process of the medical device in selected regions like Japan, Australia and Brazil
Keyword: Medical Device, Regulatory requirements, Post Marketing Surveillance
EOI: http://eoi.citefactor.org/10.11209/ijpr.10.03
DOI: https://doi.org/10.31838/ijpr/2018.10.03.057
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0.12
2018CiteScore
 
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