There has been a lot of heat surrounding the issue of whether medical devices should be considered as drugs or not. Technically, medical devices are engineered products designed for specific medical purpose. On this line, recently the Drugs and Technical Advisory Board (DTAB) have decided to mandate all medical devices as drugs under Drugs and Cosmetic Act. Now, all medical devices imported or locally manufactured will need the Central Drugs Standard Control Organisation (CDSCO) certification for import, manufacture, and sale of these devices.
The move is in its place to ensure each and every patient gets safe and tested medical devices and cut down the debacles of efficacy related to these devices. At present, only 23 medical devices are under the regulations while others like various diagnostic kits, equipment’s analysers are still - off the radar. On the basis of risk calculation,…
