India’s vast and diverse population creates an abundance of opportunities for foreign medical device manufacturers to market their products to both professional and end user needs. The Indian medical device market is “exploding” with many opportunities and many challenges. India is the fourth largest market in Asia worth approximately $3 Billion USD with a projected growth of approximately 15% during the next 5 years.
With all of this opportunity, there is an evolving regulatory landscape. Prior to 2005 there were no regulations governing the distribution of medical devices in India. Currently, with only certain medical devices regulated as drug products, there is a push by legislators and the ministry of health to have all medical device products independently regulated and controlled.
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