REGULATORY REGIME ON INDIAN MEDICAL DEVICE INDUSTRY-A WAY FORWARD
Journal Title: Innoriginal: International Journal Of Sciences - Year 2018, Vol 5, Issue 3
Abstract
Background and Aim: 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 the Indian Ministry of Health and Family Welfare (Mohfw) released the new guidelines it comes under the Medical Device Act.The Central Drugs Standard Control Organization (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 order to ensure safety and efficacy Government set up two dedicated medical device testing laboratories in Vadodara in Gujarat and Noida in Uttar Pradesh. Methods: In this review Growth Factors Driving the Medical Device Demand in India brieflydiscussed. New regulations implemented by the Indian Government for medical devices also discussed. Result: All medical devices will be placed into one of four classes, Class A (low risk), Class B (low, moderate risk), Class C (moderately high risk), and Class D (high risk). It is based on the intended use of the device and the potential risk that comes with its use. Each class has different regulatory processes. Conclusion: Till, 2017 there were no such strict regulations for Medical devices manufacturing, import and sale. From starting 1st January 2018, new regulations implemented by Indian MoHFW. According to these rules, Test licenses will remain valid for three years; before, it is valid for one-year only.
Authors and Affiliations
VIJAY KUMAR
Keywords
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