*Five Years Citation in Google scholar (2016 - 2020) is. 1451*   *    IJPR IS INDEXED IN ELSEVIER EMBASE & EBSCO *       

logo

INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
ISSN
0975-2366
Current Issue
No Data found.
Article In Press
No Data found.
ADOBE READER

(Require Adobe Acrobat Reader to open, If you don't have Adobe Acrobat Reader)

Index Page 1
Click here to Download
IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

Click to download
 

Article Detail

Label
Label
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
Download: Request For Article
 
Clients

Clients

Clients

Clients

Clients
ONLINE SUBMISSION
USER LOGIN
Username
Password
Login | Register
News & Events
SCImago Journal & Country Rank

Terms and Conditions
Disclaimer
Refund Policy
Instrucations for Subscribers
Privacy Policy

Copyrights Form

0.12
2018CiteScore
 
8th percentile
Powered by  Scopus
Google Scholar

hit counters free