Understanding the regulatory reforms imminent in India will be crucial for foreign companies looking to enter or expand their business in India′s medical markets. While these regulations and reforms promise to clarify, unify, and expedite the process of manufacturing and importing medical devices into India, they also pose their own challenges and complications. The approach to quality of devices has depended largely on regulation.Recently introduced guidelines and the amendment in the law will provide adequate guidance for both the manufacturers and competent authorities to manage cases efficiently and appropriately. In other cases, devices have been associated with many problems. In some cases, the use of devices has certainly improved quality. They are in many cases associated with quality of care. Medical devices are now a pervasive part of modern medical care. The objective of the present study offers an overview of regulatory guidelines for medical devices in India. Clinical Investigation(CI) of the medical device to be imported: a) If Free Sale Certificate (FSC) has been issued for any MD by the National regulatory authorities, namely United States of America (Food and Drug Administration), European Union (European Medicines Agency), Australia (Therapeutics Goods CLA conducts an inspection of foreign manufacturing establishment either by itself or other notified body to whom the power has been delegated. Application no.:-Form MD-14 Fees:- Class A: One site -$1000 and each distinct MD -$50 Class B: One site -$2000 and each distinct MD -$1000 Class C or D: One site -$3000 and each distinct MD -$ 1500 Inspection of Foreign manufacturing site: $6000 Retention fee remains the same for each site and distinct MD An import license is issued through Form MD-15. Regulatory Approval process for the manufacturing of Class A, B, C and D Devices IMPORT OF MEDICAL DEVICES: (Arkala, 2018) (Wilson, 2018) (Sewlikar, 2014) The licensed manufacturer can make an application for the grant of import license to CLA through an online portal.
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