Medical Devices Sector: Prerogatives and Regulatory Reforms post COVID-19
OVERVIEW India is the 4 th Largest Medical Devices Market in the world after Japan, China and South Korea. The present Government is also trying to harness and stabilize the medical devices market in India, by allowing 100% FDI in the Medical Devices Sector. Through a recent notification, the Union Health Ministry has proposed to bring all medical devices including contraceptives and implants under the regulatory framework of the apex drug regulatory body, Central Drugs and Standard Control Organisation (CDSCO), mandating all medical devices to get CDSCO certification [1] India’s Ministry of Health and Family Welfare (MoHFW) and the Central Drugs Standard Control Organization (CDSCO) are the main regulatory bodies that are responsible for overseeing pharmaceuticals and medical devices within India. The CDSCO exercises regulatory control over the ...