FICCI estimates 14000 product types in the country but only 22 devices comes under the registration part. Addressing the issue of medical devices being dumped or sold at extremely high prices, the DCGI has assured that a robust mechanism of registration is in place to evaluate safety and quality of products. The Drug Controller General of India, Dr. GN Singh said “a new legislation is in the process of being drafted widening the scope of regulation in medical devices.” Experts say, there is huge number of below par standard medical devices available in India. They are either imported or locally made.

READ ALSO: Documents required for Medical Device Registration in IndiaStep by Step Process to Register Your Medical Device in India.

“The medical devices imports worth INR 27000 crore which may mount INR 85000 crore quickly. The medical devices segment in India worth INR 35000 crore” said a healthcare expert. Every year 3 lakh heart procedures and 1 lakh knee replacement surgeries are done in India involving medical devices. (Statistics and Figures: Medical Device Registration India).


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