New Delhi : The Central Drugs Standard Control Organisation (CDSCO) has announced classification of around 214 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, and obstetrical and gynaecological treatment have been classified under the provisions of Medical Devices Rules 2017, through different notifications. It may be noted that this is in continuation with classifying devices in these segments last year.
This includes 123 devices for obstetrical and gynaecological treatments, including abdominal decompression chamber l, birthing bed/table powered, cervical anesthesia kit, reusable or single use syringe used for cervical anaesthasia, endocervical aspirator, laparoscope system, among others.
These devices were classified under A, B and C categories under the Medical Devices Rules, based on the risk associated with them.
In another notification, the CDSCO has classified 91 devices pertaining to the dental procedures and treatment.
This include dental excavator – single use and reusable, dental examination kit, dental crown, dental impression material kit – both single use and reusable, among others.
In August, last year, the CDSCO has classified 107 devices for obstetrical and gynaecological treatments, including abdominal decompression chamber, cardiotocograph, cervical anaesthesia kit, flexible video laparoscope, foetal stethoscope, among others.
During the same month, it has classified 73 medical devices pertaining to dental practices including 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.