Regulatory Requirements and Approval Procedure of Combination Products (Medical Devices) in India

Rajneesh Verma³, Shashi Paul¹, Balamuralidhara, V.^1* & Manoj Bansode²

¹Department of Pharmaceutics, JSS College of Pharmacy, Sri Shivarathreeshwara Nagara, Mysuru
²Saiseva Biotech Pvt Ltd, CureCellsTM Cord Blood Bank, Kant Helix, Bhoir colony, Chinchwad, Pune
³Stem Cell 21 Co. Ltd 2nd & 7th fl, Urbis bld, Aetas Residence, Soi Ruamrudee, Bangkok, Thailand

Dr. Balamuralidhara, V., Department of Pharmaceutics, JSS College of Pharmacy, Sri Shivarathreeshwara Nagara, Mysuru.

Keywords: Drug Eluting; Sterilization; Medical Device Regulations

Abstract

Development of wide range of medical devices across the world resulted in the urge of unique challenges like safety concerns coupled with the diversity of products. Therefore, regulators and governments count on standards to help develop better regulation to set standards so as to develop an effective and efficient regulatory scheme. Different regulatory bodies have set regulatory requirements for manufacturing of the medical devices. Medical Device Regulations, 2017 provides detailed information about procedure for filing of application of Medical Devices to the CDSCO for its approval in India with respect to each category of medical devices which are defined on the basis of the risk involved and different parameters like intended use, type of use etc. These regulations provide the elaborately defined requirements of facilities, quality management system to be followed, regulatory timelines, regulatory requirements and approval procedure, area requirements with respect to environment condition, clinical investigation requirements for New Medical Device/investigational Medical Device, labeling for manufacturing of the Medical device in India. These Regulations are framed by the Ministry of Health And Family Welfare under the and Cosmetics Act, 1940 and Rules, 1945, in such a way to meet the global regulatory requirements and are in accordance with the regulatory requirements of other countries like USFDA and EMA etc. Medical Device Rules, 2017 is not limited to the manufacturer but also provide requirements for import of small quantity of medical devices for personnel use and for the purpose of clinical investigational purpose by the institute deals with the research and development of medical devices. This document provides guidance to assist manufacturers, traders/distributors, clinical establishments, healthcare professionals and general public on nationally recognized regulatory requirements concerning medical device in India.

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