The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve medical device product and quality of service. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study describes about the current practice of medical device industry in India. The regulatory implementation of GMP requirement in medical devices has already taken and implemented to assist small and medium-sized enterprises in compliance with the regulatory requirement. Present trend is to promote medical device manufacturing to the current regulatory requirement changes. The Indian Government is giving subsidies to one who wants to manufacture or expand their business through Make in India program.Transition in the production and the advanced technologies involved in the medical device industry provides the greater scope to the competent authorities that India is one of the medical device manufacturing sector around the world with a safe, quality product which meant for intended purpose which gives best performance to satisfy the customers around the world by implementing QMS as per the recent regulatory changes.
