India to regulate more med devices as drugsApril 9, 2019
The health ministry has notified eight more medical equipment, including all implantable devices, as “drugs” effective from April 1, 2020.
This step will enable the regulation of some of the widely used medical devices along the lines of pharmaceutical products to ensure their quality and safety.
The notified list includes all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator.
This is in addition to the 27 categories of devices that were notified as drugs till last year, including blood pressure monitoring devices, digital thermometers and glucometers that were notified in December 2018.
The decision was taken after consultation with the Drugs Technical Advisory Board, according to the ministry. A Gazette notification was issued to this effect.
The move is lauded by healthcare NGOs saying that the decision would help ensure the quality of the diagnostic equipment as well as the safety of the patients. Majority of medical devices are unregulated in India, as there is no regulatory framework for medical devices, currently.