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 The Central Drugs Standard Control Organisation (CDSCO) has announced risk classification of 187 medical devices pertaining to interventional radiology under Medical Devices Software, under the Medical Devices Rules (MDR), 2017, as part of classifying and regulating various medical devices under the rules.
The final notice with the classifications is announced following the publication of the draft classification list on January 6, 2017. In January, the CDSCO has revisited devices under Interventional Radiology, Radiotherapy, Oncology, and Class A (non-sterile and non-measuring) and issued an updated list for each category, with new entries added based provisions in the Medical Devices Rules (MDR), 2017 and the internationally-followed classification.
The updated list finalised now has five devices under Class A, including grid for MRI (needle guide positioner), orthopaedic x-ray ruler, radiologic quality assurance instrument, tissue specimen x-ray tomography system, and x-ray film ruler.
Out of the total 187 devices classified under the category, 100 are classified as Class B, including automatic-aperture-control diagnostic x-ray system collimator, axial length measuring ultrasound system, bladder ultrasound imaging transducer, bladder volume ultrasound imaging system, bone sonometer, computed radiography digital imaging scanner, contrast medium injection system syringe, dental computed radiography digital imaging scanner, permanent and superconducting magnets for extremity MRI system, among others.
The list also categorises a total of 79 interventional radiology devices in Class C, including angiographic x-ray system, mobile, stationary and portable basic or general purpose diagnostic x-ray system, doppler for blood flowmeter catheter, cardiovascular MRI system magnets and cardiovascular ultrasound imaging system, mobile, stationary and portable digital mammographic x-ray system, among others.
In Class D, there are three devices listed, including coronary optical coherence tomography system catheter, integrated ultrasound and electrocardiograph and stethoscope unit, and intracorporeal central nervous system ultrasound transducer/probe.
The classification also carries the general intended use of each of the devices, as a guidance for the applicant companies who intend to furnish applications for manufacturing or import of medical devices under the Rules. However, a device may have a specified intended use as specified by its manufacturer.
The drug regulator also added that the list is dynamic and is subject to revision from time to time under the provisions of MDR, 2017.
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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