RECENT ADVANCEMENT AND RULES REGULATIONS RELATED TO MEDICAL DEVICES AS PER CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (CDSCO) IN INDIA IN COMPARISION WITH SOUTH KOREA

Ashok Kumar P.*, Prajwal M., Priya G., Gudagur Jyothi, Shwetha S. and Kavya H. L.

ABSTRACT

Medical device in India are regulated as drugs by the Central Drugs standard & control organization (CDSCO) as per the provisions of Medical device rules 2017 issued by the Govt under the Drug and cosmetics Act 1940, which are the new regulations for medical device in India, keeping pace with the requirements. These rules cover various aspects of device related regulations, advancement, including classification, registration, manufacturing and import, labelling, sales, and post market requirements, etc. The rules are a positive step and encompass most of the CDSCO approval process, which mandates that the devices are safe and performs its intended function. However, with rapid advancements in medical device technology, much is desired in clarity and revamping of the current regulatory system to harmonize standards to be in-line with advanced regulations. In vitro diagnostic medical device is an important segment in the global health care industry at a value for treatment medical diagnosis of general well being of public.

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