Asia’s fourth-largest market of approximate USD 5.2 Billion worth is Indian medical device sector and as per the recommendations of 2017 National Health Policy, strengthening and regulation of medical instrument suppliers in India is required. To do this establishing of a regulatory body for medical devices is solicited, which will be helpful in the harmonization of domestic standards with international standards and further help to innovate and manufacture world class products in India.
In line with health policy recommendations, Ministry of Health & Family Welfare has notified Medical Devices Rules, 2017 and thus notified Medical devices under the Drugs and Cosmetics Act, which includes their import, clinical investigation, manufacture, sale, and distribution. The new rules are as per and in line with international regulatory exercises and will cut down unnecessary and time-consuming paper-work, a bid of government to promote make in India and for ease of doing business in India.
To monitor and execute the new Medical Devices Rules, 2017 a separate and dedicated wing is set up under Drug Controller General of India with effect from 1.1.2018.
Surgeine Healthcare (India) Private Limited is proud to be the first firm to apply for MDR 2017, Surgeine is engaged in manufacturing of single-use surgical apparels like surgical gowns, surgical drapes and equipment covers.