As Rashed mentioned, no medical device regulations whatsoever existed in India before 2005. It’s pretty stunning to consider that such a large market (over 1.3 billion) could have such lax regulatory affairs in such a critical field. However, it’s less surprising when considering that India has long been plagued with medical treatments of poor (or even negative) value. Even today, Homeopathic Medicine dominates significant segments of the Indian medical system.

Increasing wealth has resulted in a larger, better educated middle class. As a result, India has been undergoing a number of cultural and governmental developments. One of these is increased regulatory attention toward the growing medical device development field. The expected approval time for new devices is 6-9 months currently (with a technical presentation adding another 3-6 months). Again as Rashed mentioned, devices must show previous approval in the US, Canada, an EU country, Australia, or in Japan to obtain registration without going through a lengthier approval process.