Home About Qualtech NEWS INDIA: Four More Medical Devices Have Been Notified as Drugs - January 2019
INDIA: Four More Medical Devices Have Been Notified as Drugs - January 2019

January 15, 2019

1 Four New Devices Notified - Picture

The Government of India has announced that four more medical devices will henceforth be notified as drugs, under the Drugs and Cosmetics Act 1940. It will enable the government to ensure their quality and performance. These devices are the commonly used medical devices nebulizers, blood pressure monitors, digital thermometers and glucometers.

The Drug Controller General of India (DCGI) will regulate the import, manufacture and sale of these devices from January 2020.

Companies which are engaged in manufacture and import of these equipment will have to seek necessary permission or license from DCGI from January 1, 2020 onwards. All these devices will have to be registered under quality parameters prescribed under Medical Devices Rules, 2017 and other standards set by Bureau of Indian Standard (BIS) certification.

The DTAB, the country's highest drug advisory body, had approved the proposal to include them under the purview of the Drug law. Currently, only 23 medical devices are monitored for quality by the country's drug regulator.

With four new devices being notified, 27 medical devices now fall under the definition of drugs under the Act. Other medical equipment are sold without any quality checks or clinical trials.

The Ministry of Health has proposed expanding the list of devices in eight new categories, under the definition of 'drugs' to bring them under the purview of the Drugs and Cosmetics Act, 1940.

The eight categories include implantable medical devices, MRI equipment, CT scan equipment, defibrillators, dialysis machines, PET equipment, X-ray machines and bone marrow cell separator.

The proposal to bring high-end medical devices like implants, X-ray machines, MRI and CT scan equipment, dialysis machines under the purview of the drug law is being deliberated.

 

Reference:

Ministry of Health, India’s Notification Dec 3, 2018

 

 

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Home About Qualtech NEWS INDIA: Four More Medical Devices Have Been Notified as Drugs - January 2019