In a Notification dated 13th November, 2019 the Central Drugs Standard Control Organisation (“CDSCO”) has stated that, in addition to the devices specified in notification dated 3rd December, 2018, now devices that are used to monitor (unit parameter) temperature or blood pressure like digital thermometer, blood pressure monitoring device will be considered under the purview of Drugs and Cosmetics Act,1940 from 1st January, 2020.
However, devices whose primary purpose is composite and not individual or unit monitoring of parameters will not be taken into consideration.
Source: Central Drugs Standard Control Organisation