Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry
ISSN: 0975-413X
Abstract
Comparison of Regulatory Requirement of Medical Device for Registration in India, USA and Japan
Author(s): Khyati Patel*, Shruti Jagirdar and Kripa PatelMedical device in recently has been used largely which is concern the safety and effectiveness of the medical device by the regulated country. Medical device standard has been harmonized by the GHTF study group for control of standard of in-vitro medical devices. Even if the same tests have been performed during a process, all medical devices and equipment must go through a mandatory set of tests. The present review discuss about the detail comparative study about the medical device in India, USA and Japan. These regulated authorities make sure that the medical device is safe and efficacious and provide the intended use by manufacturer. Different regulatory guidelines are established for the medical devices by each country for maintaining quality and safety of device. Medical device manufacturing in those countries having large population should be taken seriously and introducing any unsafe product that affect the public health shall be regulated by authorities.
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