Nebulizers, BP Monitors, Digital Thermometers To Need BIS Certificate From 1 Jan

NEW DELHI, 14 OCT 2019:

The government will now regulate quality and performance standards of commonly used medical devices such as nebulizers, blood pressure monitors, digital thermometers and glucometers, effective 1 January 1, 2020. According to the ministry of health and family welfare, these devices will have to be registered under the quality parameters prescribed under Medical Devices Rules 2017 and other standards set by the Bureau of Indian Standard (BIS) certification.

After the Drug Controller-General of India (DCGI) last year notified these items as drugs under the Drugs and Cosmetics Act, the government will also regulate the import, manufacture and sale of these devices.

At a recent meeting, the Drug Technical Advisory Body (DTAB) approved the proposal to include these medical devices under the purview of the Drugs and Cosmetics Act, 1940.

There will a total of 27 medical devices that will now fall under the definition of drugs under the Act with the addition of four of these devices. So far, these equipment have been sold without prior quality checks.

The ministry of health and family welfare had proposed to expand the list of devices in eight new categories, under the definition of ‘drugs’ aiming to bring them under the Drugs and Cosmetics Act.

These eight categories are as--implantable medical devices, dialysis machines, PET equipment, X-ray machines, MRI equipment, defibrillators, CT scan equipment, and bone marrow cell separator. Livemint