Regulatory regime on Indian medical device industry – a way forward Regulatory regime on Indian medical device industry – a way forward

Abstract

Medical devices are essential for safe and effective prevention, analysis, cure and rehabilitation of illness and disease. Till December, 2017 Medical Devices come under the Drugs and Cosmetics Act 1940, but after Indian Ministry of Health and Family Welfare released the new guidelines it comes under Medical Device Act. CDSCO launches online service for medical devices, diagnostics in Sugam portal which effective from 1st January 2018. This will help manufacturer to submit applications for grant of import, manufacture, clinical investigation, sale and distribution licenses of medical devices and diagnostics. In 2020, approved medical devices must bear unique identifiers. From January 1st2022, medical devices that are approved for import, sale, or distribution in India must bear two different types of unique identifiers. In order to ensure safety and efficacy Government set up two dedicated medical device testing laboratories in the country at Vadodara in Gujarat and Noida in Uttar Pradesh. Such type of testing labs will allow manufacturers to overcome deficiencies in their products and improve product value in the market which is a neglected aspect until now.