The Ministry of Health and Welfare (“MORTH”) in a Notification dated 28th December 2020 has notified the following medical devices as drugs:
1. Nebulizer,
2. Blood pressure monitoring devices,
3. Digital thermometer and
4. Glucometer.
The importers and manufacturers are required to take importing / manufacturing license from Central Licencing Authority or State Licencing Authority which will be effective from 01.01.2021.
Under circumstances, where an existing manufacturer / importer who is already importing / manufacturing any of the afore-stated devices has submitted the application to the Central Licencing Authority or State Licencing for grant of importing / manufacturing license in respect of the afore-stated devices, will be considered to be valid and the importer / manufacturer may continue to import or manufacture the devices up to six months from 28th December 2020 or till the that time the Central Licencing Authority or State Licencing Authority may take a decision on the said application, whichever is earlier.
Source: Ministry of Health and Family Welfare
