MEDICAL DEVICE REGULATIONS AND CURRENT CHALLENGES IN THE GROWTH OF MEDICAL DEVICES IN INDIA: AN OVERVIEW
AbstractMedical device, a device or instrument or apparatus or that is used to treat or prevent or diagnose or mitigate or cure the disease or to replace the structure of the body parts mimicking the natural function. The medical device sector started to grow rapidly in the last 8 years. Developed countries like the USA, European Union, and Japan concentrated on this sector to increase their production capability, and regulations were stringent to prevent unlawful happenings. India still lags in the development of the medical device sector. Earlier the rules and regulations for medical devices in India were followed the same as the drugs and cosmetics, which raised various questions regarding the regulatory process of medical devices. Very later the Medical Device Act 2017 was introduced which explained the manufacture, import, export & clinical investigation regulatory process required for a medical device. The Medical Device Act 2017 is framed as competent with the other national authority regulators and internal medical device regulator forums. This paper discusses the Medical Device Act 2017, the crisis which stopped or delayed the medical device sector growth in India and suggests corrective and preventive action to the mentioned crisis.
Article Information
7
1053-1058
472 KB
321
English
IJPSR
Thillai G. E. Govinda Rajan, M. Vignesh *, N. Swathi, N. Swetha, S. Priyadharshini, P. S. Sivaranjani and S. Sophia
Department of Pharmaceutics, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu, India.
vignesh.m@sriramachandra.edu.in.
01 August 2023
15 February 2024
20 March 2024
10.13040/IJPSR.0975-8232.15(4).1053-58
01 April 2024
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