**Policy Summary:**
Effective January 1, 2020, the Government of India, through the Directorate General of Health Services, Ministry of Health & Family Welfare, Central Drugs Standard Control Organisation, Medical Devices Division, will regulate digital thermometers and blood pressure monitoring devices. This regulation, as per notification S.O. 5980 (E) dated December 3, 2018, applies specifically to devices primarily intended for temperature or blood pressure monitoring. Devices with a primary intended purpose that is composite, rather than individual unit monitoring of these parameters, are currently excluded from these regulations. The Drugs Controller General, Dr. V.G. Somani, is the designated contact person. The policy reference number is No. 29MISC32018DC 165, dated March 14, 2019.
Key Entities Referenced
Directorate General of Health Services: A department under the Ministry of Health and Family Welfare, Government of India.
Ministry of Health Family Welfare: A ministry of the Government of India responsible for health policy.
Central Drugs Standard Control Organisation: National Regulatory Authority responsible for regulating medical products in India.
Medical Devices Division: A division within the Central Drugs Standard Control Organisation.
Digital Thermometer: A medical device used for measuring body temperature.
Blood Pressure Monitoring Devices: A medical device used for measuring blood pressure.
S.O. 5980 E: A notification number, likely related to a legal order or statutory order.
Dr. V. G. Somani: Drugs Controller General of India, an individual in a position of authority.
No.
29/MISC/3/2018-DC (165)
Government of India
Directorate General of Health Services
Ministry of Health & Family Welfare
Central Drugs Standard Control
Organisation
(Medical Devices Division)
Date: 14) 3!1)20!9
Notice
The devices like Digital Thermometer, Blood Pressure Monitoring Devices
the primary intended purpose of which is for temperature monitoring or blood
pressure monitoring (unit parameter) will be considered under the purview of
regulation with effect from 01.01.2020 which are already notified vide S.O. 5980 (E)
dated 03.12.2018. However, those machines whose primary intended purpose is
composite and not the individual/unit monitoring of the parameters as mentioned
above are not considerable at this stage under these regulations.
Ne .
(Dr. V. G. Somani)
Drugs Controller General (I)