The Drug Controller General of India has issued a notice classifying 133 medical devices from general hospital and orthopaedic instruments. This is done under the provisions of Medical Devices Rules, 2017.

According to the regulator, around 86 devices including bed exit monitor (fall prevention), stand-on patient scale, clinical color change thermometer, apgar timer, hydraulic and manual adjustable hospital bed, non powered flotation therapy mattress, therapeutic medical binder, burn sheet, neonatal eye pad, nipple shield, lamb feeding nipple, suction snake bite kit, therapeutic scrotal support, cardiopulmonary resuscitation board, medical insole, medical examination light, skin pressure protectors, body waste receptacle, washers for body waste receptacles, hand-carried and manual wheeled stretchers, liquid crystal vein locator, blood bank centrifuge, among others are classified as Class A medical devices.

The decision comes as the latest in the drug regulator’s efforts to classify the medical devices sold in the country based on the perceived risk of the product type and its use in patients. The measure is to help the authority to bring in all the medical devices under the regulatory control, according to experts.

Another around 38 medical devices including Liquid crystal forehead temperature strip, spinal fluid manometer, electrically powered spinal fluid pressure monitor, sterilisation process indicator, paediatric medicare crib, medical bassinet, pressure infusion for an I.V bag, intravascular administration set, automated air removal system, patient care reverse isolation chamber, jet lovage, electrically powered patient lift, ultrasonic cleaner for medical instruments, remote medication management system, ultraviolet radiation environmental disinfection device, vacuum-powered body fluid suction apparatus, sterilisation wrap, motorised wheeled stretcher among others are classified as Class B medical devices.

Eight medical devices including electronic monitor for gravity flow infusion systems, ingestible event marker, ultraviolet radiation chamber disinfection device, ethylene oxide gas steriliser, dry-heat steriliser, steam steriliser, liquid chemical sterilants or high level disinfectants and hydrogen peroxide gas plasma sterilisation system are classified as Class C medical devices.