MEDICAL DEVICES AND THEIR APPROVAL PROCEDURE IN INDIA

Sanjana Pabbati; Kirti Hira; A. Sajeli Begum

doi:10.22270/ijdra.v4i3.186

Sanjana Pabbati
Kirti Hira
A. Sajeli Begum

DOI https://doi.org/10.22270/ijdra.v4i3.186

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.

Keywords: Drug and Cosmetic Act 1940 and Rules 1945, CDSCO, FDA Regulations.

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