The Economic Times

Medical device rules may get tougher: Govt plans new powers to stop manufacture, sale of unsafe, defective and spurious products, order destruction

The government is considering tougher medical device rules that could give regulators explicit powers to stop the manufacture, sale or distribution of unsafe, defective, substandard or spurious products and order their destruction. The proposed amendment to Rule 30(1) of the Medical Devices Rules, 2017, is aimed at strengthening enforcement, reducing ambiguity and ensuring potentially harmful devices are removed from circulation more quickly.