CDSCO Classifies 12 New Notified Medical Devices

Mumbai, 20 May 2019: In order to ensure patient safety, the Drugs Controller General India (DCGI) has classified the 12 newly notified medical devices and in vitro diagnostics (IVDs) based on the intended use of device, associated risks and other parameters as per the provisions of new Medical Device (MD) Rules, 2017 effective January 1, 2018.

The names of the devices classified are CT Scan equipment, MRI equipment, dialysis machine, defibrillators, PET equipment, x-ray machine, nebuliser, glucometer, bone marrow cell separator, blood pressure monitoring device, digital thermometer and organ preservative solution.

As of today, 37 medical device categories have been notified. Earlier, 26 medical devices were notified between 2005 and 2017 which has under its ambit 364 products. In December, 2018 three new devices like nebuliser, glucometer and surgical gowns were notified.

In a notification dated February 8 this year, the union health ministry brought all implantables along with eight new medical equipment like CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-Ray machines and bone marrow cell separator under the regulatory framework. 

While CT scan has use as x-ray source equipped with digitally scanned computer technology to create cross-sectional images of the body, MRI equipment is a medical imaging procedure using radio waves, magnetic fields and magnetic field gradients to generate images of organs in the body. 

Defibrillator is a device that automatically analyzes the rhythm of heart of cardiac arrest patients and delivers an electrical shock to the heart for restoring the normal rhythm of heart. Dialysis Machine is used for acute or chronic kidney failure that filters blood to remove excess water and waste products.

PET equipment is intended to detect the gamma radiation and positron emitting radionuclides in the body and produce cross-sectional images which reflect the distribution in the body or individual organs. X-Ray Machine is meant to diagnose or treat patients by imaging the internal structure of the body to assess the abnormalities in the body.

Nebuliser device is used to administer medications in the form of mist to inhale for respiratory disorders. Glucometer device is used to measure the concentration of glucose in blood and organ preservative solution is meant for hypothermic flushing, storage and transport of organs and to maintain the organ vitality during transplant into human recipients.

Whereas bone marrow cell separator is a general lab equipment to be used to isolate target cells and cells concentrate from bone and blood, blood pressure monitoring device used to measure the diastolic and systolic blood pressure and digital thermometer is used to record the body temperature.

Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics (D&C) Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board (DTAB) notified MD Rules, 2017 dated 31st January, 2017. Pharmabiz