New Delhi : The Central Drugs Standard Control Organisation (CDSCO) has announced classification of over 400 medical devices in various therapeutic segments, as part of its efforts to bring in the medical devices under the prescribed rules in the country.
The medical devices pertaining to dental, paediatrics, neonatology, urology and obstetrical and gynaecological treatment have been classified under the provisions of Medical Devices Rules 2017, through different notifications on August 23, 2021.
This includes 107 devices for obstetrical and gynaecological treatments, including abdominal decompression chamber, cardiotocograph, cervical anaesthesia kit, flexible video laparoscope, foetal stethoscope, among others.
Eighty eight medical devices in the urology segment, including bare-metal urethral stent (short term), ultrasonic cysts meter probe, drip wearable urinal, female wearable urinal (reusable), flexible video cystonephroscope, pyeloscope and urethral patency kit were also classified under A, B and C categories under the Medical Devices Rules, based on the risk associated with them.
A total of 136 devices pertaining to paediatric and neonatal segments has also been classified by the drug regulator. Airway pressure/oxygen monitor, anaesthesia face mask for single use, cerebral oximeter, electric pad whole-body heating system, enteral feeding kit, infant bed crib top, infant bed restraint, infant care table, infant incubator control unit, among others are classified under the Rules, through an order issued by the Drug Controller General (India) Dr V G Somani.
Seventy Three medical devices pertaining to dental practices are also classified through an order. This includes dental impression material, reusable dental spatula, dental crown – metallic/ceramic, dental crown – metal/polymer, dental suction system, zinc poly carboxylate dental cement, dental surgical procedure kit – medicated and reusable, among others.
Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules related to that. The medical devices are classified based on the intended use, risk associated with the device and other parameters specified in the first schedule of the Medical Devices Rules, 2017.