As part of its efforts to regulate the medical devices in the country, the Drugs Controller General (India) has issued a notice classifying 77 medical devices pertaining to oncology under the provisions of Medical Devices Rules (MDR), 2017.
The drug regulator has been classifying 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.
In the latest notice, four devices are classified under the risk Class A – single use cervical cone knife and cervical cytology scraper, extracorporeal extravascular-circulation hyperthermia system applicator, and tele thermographic system.
A total of 19 medical devices are classified under the risk Class B including balloon kyphoplasty kit, bladder instillation buffer solution, breast transilluminator, extracorporeal breast ultrasound imaging system, colonic cytology sampling set, electronic clinical breast examination system, endocervical aspirator, externally-propelled flexible video colonoscope, extravascular-circulation hyperthermia system, intracorporeal extravascular-circulation hyperthermia system applicator, flexible fibreoptic bronchoscope, flexible fibreoptic mediastinoscope, flexible ultrasound bronchoscope, and flexible video bronchoscope, among others.
A total of 47 medical devices are under the risk Class C including accelerator system chair, alternating electric field antimitotic cancer treatment system generator, remote-after loading and manual anorectal brachytherapy system applicator, breast 3-D infrared imaging/vascular analysis system, intracorporeal breast ultrasound imaging system, intraoperative cancer diagnostic probe, computer vision/machine learning-aided software application for cancer detection, electrocancer therapy system, among others.
Seven medical devices have been classified under the risk class D – alternating electric field antimitotic cancer treatment system, alternating electric field antimitotic cancer treatment system transducer array, brachytherapy source spacer, coronary artery brachytherapy system applicator – manual after loading, bio absorbable and non bio absorbable embolization particle, and stereotactic radiosurgery system for central nervous system (CNS).
The notice provides the general intended use of these devices, and said that these are for guidance to the applicants who intend to furnish application of import or manufacture of medical devices under the provisions of the MDR, 2017. However, a device may have specific intended use as specified by its manufacturer, it added.
As reported earlier, the drug regulator classified a group of 48 medical devices pertaining to oncology under the provisions of the MDR, 2017 in October, 2022.
The risk associated with the Class A is perceived to be low, while B has low to moderate risk, C has moderate to high risk and D has the high risk, according to the widely accepted classification criteria.
The safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules and for the regulation of medical devices for imports, manufacture, clinical investigation, sale and distribution, the Central government has notified the Medical Devices Rules, 2017, which commenced from January 1, 2018.
