Home India India’s Medical Device Regulatory Framework is a Mess

India’s Medical Device Regulatory Framework is a Mess

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Read Sameeksha Khare’s article in Fit about the chaotic, haphazard and tangled regulatory mess that represents India’s medical device industry. With patient injury and quality problems mounting, the medical device industry continues to grow at a good pace—from $5.7 billion to over $9.6 billion by 2022 according to the Fit story.

Not till recently were devices even regulated under device statute, but rather were regulated by drug laws. In 2017 India passed what the article’s author called “woefully inadequate” Medical Device Rules (MDR).  Read Khare’s story for further information for those interested in the medical device industry (and rules) in India.

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