Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists for medical devices and IVD products in order to clarify regulatory pathways and requirements.
According to Emergo by UL consultants in New Delhi and Hyderabad, the two new notices cover proposed classifications of 24 medical device categories as well as three categories for IVDs.
Medical device classifications
Among the 24 medical device classifications, CDSCO has included software as a category for the first time. The category would include 60 device types such as data analysis software; secondary displays for glucose monitoring, insulin pump and other devices; and orthodontic and dental software…