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The Central Drugs Standard Control Organisation (CDSCO) has released an update on the existing risk based classification list of four categories, revisiting the existing list and adding new entries.
The drug regulator has sought the industry to submit their comments on the same within 30 days from the date of publication of the draft.
The lists of Interventional Radiology, Radiotherapy, Oncology, and Class A (non-sterile and non-measuring) medical devices have been revisited through the update, and new entries have been added based on their classification as per the provisions in the Medical Devices Rules (MDR), 2017 and the internationally-followed classification, said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), in the notice issued on January 6, 2025, seeking comments.
The drug regulator requested all concerned associations and stakeholders to forward their comments by filling a Google form provided with the notice, within the stipulated timeline for consideration.
According to the updated list, the interventional radiology category has a total of 186 devices including angiography related devices in the risk Class C, cardiovascular MRI systems, contrast medium injection system control unit and administration set, and hand controller kit, and full-body MRI systems in Class C, ultrasound and x-ray related devices among others in Class B, and devices such as grid for MRI (needle guide positioner) along with other devices in Class A.
In the radiotherapy category, a total of 114 devices are included, including absorbable tissue spacer for radiotherapy, gamma knife for radiotherapy or surgery, among others in Class D, and various devices for brachytherapy in Class C.
In the category of oncology, a total of 75 devices has been listed including accelerator system chair, accelerator system quality assurance device, balloon kyphoplasty kit, breast ultrasound imaging system and cancer diagnostic probe among others in Class C, electronic clinical breast examination system, externally propelled flexible video colonoscope, and facial prosthesis among others in Class B.
In the fourth category of Class A (non-sterile and non-measuring) medical devices, a total of 803 devices has been listed in the draft notice, including reusable and single use abdominal support/belt/binders, abrasive polishing agent, absorbent cotton wool, and acupressure calf band, wrist band among others.
According to the Rule 4 of Chapter II of the MDR, 2017, the medical devices other than in vitro diagnostic medical devices has been classified on the basis of various parameters mentioned in the Part I of the First Schedule of the Rules, as Class A comprising low risk devices, Class B for low moderate risk devices, Class C for moderate high risk products, and Class D for high risk products. Similar classification has been made for the in vitro diagnostic medical devices, based on Part II of the First Schedule of the Rules.
The Central Licensing Authority shall classify medical devices referred to in Rule 2, based on the intended use of the device and other parameters specified in the First Schedule of the Rules. The rules also provide powers to the Central Licensing Authority, from time to time, to make additions or deletions in such lists of medical devices or modify the class of any medical device.
The classification helps the regulator to better regulate the sector, by issuing licenses, ensuring regulatory compliance across the categories, and bringing in international standards of regulations.
The government has notified all medical devices to be regulated under the MDR, 2017, in February, 2020 following various discussions on the need to regulate the sector, which has been seeing growth in the recent years.
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