A bill which is awaited to be passed in the parliament of India which would enable distinguish medical devices and drugs regulations in India. An association of medical device manufacturer, AdvaMed said there are around 14000 types of medical devices and only 22 are listed as notified medical devices in India and even these 22 medical devices are classified as drugs. It said “The new bill will be historic as it will differentiate medical devices and drugs”. READ ALSO: How to Register your medical device in India, Step by Step process for Registering your Medical Devices, Things to remember on the preparation of regulatory dossier.

“The regulation of medical devices in India will better address the needs of the patients” said Sanjay Banerjee, Chair of AdvaMed India. It is a benchmark legislation as the regulatory system will ensure international standards, high quality and patient safety. This would improve domestic manufacturing allowing global competition within the country and international medical device manufacturers to invest (READ ALSO: Why Invest in India?) which will fall in line with “Make in India“. After the first introduction of the bill in Rajya Sabha in 2013, the bill has gone through several revisions, consultations to make the proposed bill to ensure all concerns to be addressed.