Main Article Content
The term “medical device” (MD) encompasses a diverse array of products, such as examination gloves and computerized dermoscopy devices, among others. These devices are subject to regulation inside the European Union (EU) under a recently enacted regulatory framework. The importance of medical devices is experiencing a growing trend in the healthcare sector. One of the main obstacles encountered by companies involved in the development and manufacturing of medical devices is the need to remain updated on regulatory obligations and successfully integrate them into their operational protocols. The authors of this study categorize medical devices according to the regulatory frameworks in Europe and India. The researchers also investigate the regulatory framework pertaining to the regulation of medical devices. In order to analyze the areas in which the Indian legal system falls short in comparison to the European Union (EU), a comparative analysis was conducted in the last section.