Abstract

INTRODUCTION TO MEDICAL DEVICES AND ASSOCIATED REGULATIONS IN INDIA

Mallika Adhatrao*

ABSTRACT

Prominently there are three integral industry pillars of modern healthcare technology systems which are drugs, vaccines and medical devices. Medical devices is broadly categorised from bandages and syringes to sophisticated devices that incorporate bioinformatics, nanotechnology, engineered cells and artificial intelligence. Medical devices market in India is sharing place on top 20 medical device markets in the world. It is presently valued at $5.2 billion and is expected to reach $50 billion by 2025. However, India imports approximately 70% of its medical devices. This is because consumables and disposables make up the major share of products manufactured by the Indian Medical Device Industry (MDI). Therefore, to meet the healthcare needs of the population, expensive medical devices are imported. Production and monitoring of medical devices are highly scrutinized under various regulated activities. In India, Central Drug Standard Control Organization(CDSCO) has released Indian Medical Device Rules, 2017, which are the new regulations for medical devices in India which made significant progress in developing local pharmaceutical and biotechnology capacity mainly owing to concerted state policy initiatives and supportive institutions. This has resulted in increased access to affordable drugs and vaccines to people in India These rules cover device related regulations, including classification, registration, manufacturing and import, labelling, sales, and post market requirements, etc. The paper aim to throw light on the medical device department in India.

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