Strict norms for 8 medical devices

THE HEALTH MINISTRY HAD EARLIER REGULATED 23 DEVICES AND WITH THIS, THE NUMBER OF SUCH EQUIPMENT HAS INCREASED TO 31

NEWDELHI: In order to ensure better quality of medical devices imported into the country, the Union ministry of health and family welfare has added eight more devices to the list of drugs under the Drugs and Cosmetics Act, 1940, and will now require strict regulatory compliance.

The ministry through a gazette notification issued on Friday specified all implantable medical devices such as cardiac stents, orthopaedic and ocular implants etc, CT scan equipment, MRI equipment, defibrillators, dialysis machines, PT equipment, X-ray machines and bone marrow cell separator as drugs.

“...Most of these devices are imported and those not regulated didn’t require a license. After having been included in the list these devices will have to follow all norms that are followed by the drug manufacturers and importers,” said a senior health ministry official, requesting anonymity.

The health ministry had earlier regulated 23 devices and with the addition of eight more such devices, the total number of devices to be specified as drugs has increased to 31. It would require same checks as drugs.

“The idea is to gradually bring in more and more medical devices under our regulatory ambit. Quality assurance is our top priority, and there will be no comprise as far as patient safety is concerned,” said Arun Singhal, additional secretary, health ministry. The notification will come into effect from April 1, 2020.

“It’s a good thing to check the quality of these devices in the market,” said Dr KK Talwar, former member, MCI board of governors.