CDSCO releases updated classification list of 4 medical device categories; seeks industry feedback
Central Drugs Standard Control Organisation (CDSCO) has released an updated classification list of four categories of medical devices.
The regulator has asked the stakeholders and associations to submit their comments within 30 days from the date of publication of the draft.
“The existing classification lists of the following categories have been revisited and new entries have been added based on their classification as per the First Schedule (Part I) of the MDR, 2017, and the internationally-followed classification. These include interventional radiology, radiotherapy, oncology,y and class A (non-sterile and non-measuring) medical devices,” said Dr Rajeev Singh Raghuvanshi, Drugs Controller General, in the notice.
Under Rule 4(3) of Chapter II of the MDR, 2017, the Central Licensing Authority needs to classify such medical devices as per a risk-based approach.
Giving a break-up of the devices, 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, 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.
Likewise, in the radiotherapy category, 114 devices are included, including an absorbable tissue spacer for radiotherapy, a gamma knife for radiotherapy or surgery, among others in Class D, and various devices for brachytherapy in Class C.
In oncology, 75 devices have been listed including an 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 Class A (non-sterile and non-measuring) medical devices category, 803 devices have been listed in the draft notice, including reusable and single-use abdominal support/belt/binders, abrasive polishing agents, absorbent cotton wool, and acupressure calf band, wrist band among others.
“The draft of the classification lists is annexed for finalization. All concerned associations/stakeholders are requested to forward their comments by filling up the form within 30 days from the date of publication of this draft,” said Dr Rajeev Singh Raghuvanshi.
MB Bureau
