Regulatory requirements for medical devices and IVD (invitro diagnostic) kits in India

This course is developed with the help of subject experts by Clinical Development Services Agency (CDSA), an extramural unit of Translational Health Science & Technology Institute (THSTI), Department of Biotechnology, Ministry of Science & Technology, Government of India. The course has been reviewed for it’s content and quality by Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, Government of India.

Demonstration of safety and efficacy of medical device and in vitro diagnostic (IVD) kit for use in humans is essential before the product can be approved for import or manufacturing and marketing in the country. Medical devices are currently regulated under the definition of DRUG. The Rules are:-Rules 109-A - Labeling of medical devices Rule 125-A - Standards for medical devices Schedule M III - QMS requirements Schedule R- Standard for mechanical contraceptives Schedule R1-Standards for medical devices Schedule DII -Annexure B – IVD Recent amendments made under the Medical Devices rules & “Medical Devices Rules 2017’’ [G.S.R. 78 (E) Dated the 31st January 2017] are published and are mandatory w. e. f. 1st January 2018.Upon completion of this online course, the trainees will understand:

1. Medical device and in vitro diagnostic (IVD), classification and types of medical devices
2. Standards of medical device and testing, personnel involved, Quality Assurance, Quality Management System
3. Manufacturing license, inspection, fees, import, export, etc.