India: Medical Device Labeling

In late September 2014, the Indian Health Ministry released several amendments to the country’s Drugs and Cosmetics Rules, effective immediately. Medical devices must now be labeled with information such as the device name, batch number, expiration date, manufacturing license number and address of the manufacturing facility. All labels must be affixed to the outer carton of the device — not necessarily the individual unit package. For imported devices, the label can be affixed after the product has arrived in India.