|
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
|
|
|