MEDICAL DEVICES AND THEIR APPROVAL PROCEDURE IN INDIA
Journal Title: International Journal of Drug Regulatory Affairs - Year 2016, Vol 4, Issue 3
Abstract
Therapeutic treatment based on medical devices is providing technologically advanced solutions for the management of several diseases. Thereby continues to grow in market at tremendous rate. However, these treatments also carry significant risk with them, which if neglected can lead to life threatening consequences. Therefore rules and regulations are required for monitoring the entry of such devices into the market. Presently Regulatory bodies governing such regulations are at their initial stage and are improving at each step to safeguard public health as well as to ensure that effective and technologically advanced inventions reach out patient.
Authors and Affiliations
Pabbati Sanjana,, Hira Kirti, A. Sajeli Begum
Drug approval process in US, Europe and India and its regulatory requirements: A Review
Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for marketing authorization Application (MAA) approval of new drugs. In this present exertion, study expr...
STATUS OF A T POLYMORPHISM IN EXON II OF KINASE INSERT DOMAIN GENE IN WOMEN WITH PREMATURE OVARIAN FAILURE
Ovarian failure is defined as cessation of ovarian function under the age of 40 and it is characterized by amenorrhea hypo estrogenism and elevated gonadotrophin serum levels leading to infertility. Ovarian failure affec...
QUALITY BY DESIGN- A NEW APPROACH TO DRUG DEVELOPMENT
Quality by design is an essential part of the modern approach to pharmaceutical quality. A new approach to drug development could increase efficiencies, provide regulatory relief and flexibility, and offer important busi...
A retrospective study of Warning Letters issued by US FDA over 2015-2017
This paper provides contemporary climate of warning letters issued by US FDA over 2015 to 2017. With 1300$ Billion Revenue in 2017 United States stands as World’s largest Pharmaceutical Market. Being the largest, diversi...
AN OVERVIEW ABOUT NOVEL FAST DISSOLVING ORAL FILMS
Nowadays, novel fast dissolving oral films (FDF) have come in existence as an alternative dosage form in comparison with tablet, capsules, syrup and other oral dosage forms with respect to patient convenience and complia...