India – India Gives Device Manufacturers Another Year to Meet Drug Regulations

India has extended the transition to new rules for certain medical devices by 12 months. Regulators were due to start treating a clutch of devices as drugs on 1 January, but have given the industry more time to adapt.

Details of plans to treat more devices as drugs for regulatory purposes, thereby increasing oversight of the products, emerged in December 2018. At that time, the Indian government said it would treat nebulizers, blood pressure monitors, digital thermometers and glucometers as drugs from the start of 2020 onward. Later, the government vowed to treat imaging equipment as drugs from April 2020…