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Review Papers | Regulatory Affairs | India | Volume 13 Issue 3, March 2024 | Rating: 5.1 / 10
Regulatory Guidelines of Medical Devices in India - Associated Challenges and Opportunities
Vidushi Sharma [2] | Riya Mishra [2] | Vikesh K. Shukla
Abstract: Medical devices, according to the Central Drugs Standard Control Organization (CDSCO), are tools used to identify, minimize, treat, or prevent disease or abnormalities in people or animals. A medical device can be as basic as a blood pressure monitor or sphygmomanometer, or it can be as sophisticated as imaging diagnostics and other tools for managing physiological issues. The objective of the current study is to provide an overview of Indian regulatory standards for medical devices. Modern medical care now includes a vast array of medical devices. They frequently relate to the standard of treatment. The use of technology has undoubtedly increased quality in some situations. In other instances, several issues have been linked to devices. The approach to device quality has been heavily reliant on regulation. The law's revision and recently established guidelines will give producers and relevant authorities the necessary direction to handle instances effectively. While these rules and reforms aim to simplify, standardise, and speed up the process for manufacturing and importing medical devices into India, they also come with their own difficulties. For international companies wishing to enter or grow their business in Indian medical markets, understanding the impending regulatory reforms in India would be essential. It is expected that the regulations and implementation of the recommendations would result in successful outcomes. This article describes the rules that are now in effect for applications for clinical trials, manufacturing licences, and registration certificates for medical devices.
Keywords: Medical devices, classification, regulatory guidelines, import, license, key challenges
Edition: Volume 13 Issue 3, March 2024,
Pages: 1799 - 1805