Separate norms for medical devices soon

摘要

The government has decided to create separate quality guidelines for medical devices and not treat them as drugs by the end of May. It will also classify medical devices based on the risks involved. At present, medical devices are treated like drugs and are regulated by state drug regulators under the drug law - Drugs and Cosmetics Act.The guidelines would make it mandatory for both domestic as well as global medical device makers to get their products certified by notified bodies like International Organization for Standardization (ISO) and Bureau of Indian Standards (BIS) before selling them in the Indian market.