“The Medical Devices’ Rules follow the Honourable Finance Minister’s Budget Speech. This demonstrates the Government’s resolve towards bringing uniformity of regulations for the medical devices’ industry. The format of regulation is very similar to how the current regulation of other drugs and cosmetics is being done with necessary customisation” saidAnand Mehta, Partner, Khaitan & Co.
“On a quick review, the rules are to be made effective from 1 January 2018. A significant amount of familiarisation time is being given to the industry. It will be interesting to see how the industry will react to the new shelf life related requirements where some concerns were expressed” said Bhavik Narsana, Partner, Khaitan & Co.
“The medical devices proposed to be covered do not include any and all medical devices. The coverage is more or less similar to devices that were hitherto regulated as drugs under the earlier regime. As industry becomes familiar with the regulations, more devices may be added to this fold” said Sameer Sah, Associate Partner, Khaitan & Co.