Through a series of notifications, India’s drug regulator has classified a new batch of medical devices as well as a range of software used in medical devices according to risk, taking another step to strengthen regulatory oversight and shore up the domestic med-tech sector.
India’s drug regulator has approved 31 fixed-dose combination (FDC) drugs out of more than 300 banned products, after an assessment by its drugs technical advisory board. It has also asked for more phase IV postmarketing data for 19 others.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: U.S. FDA provides updates on power morcellation; FDA seeks nominations for advisory committee; CDSCO suspends import notification requirements.
