 The Central Drugs Standard Control Organisation (CDSCO) has announced risk classification of 119 medical devices pertaining to radiotherapy under the Medical Devices Rules (MDR), 2017, as part of updating classification of devices in order to keep 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.
Out of the total 119 devices classified under the category, the updated list finalised now has a single device under Class A, which is compact thermoluminescent dosimetry electrometer, intended to measure the radiation dose emitted to the phamtom, and other organs, such as eyes that have high radiosensitivity.
Around 25 devices are classified as Class B, including brachytherapy needle, brachytherapy system chair, interventional radiology percutaneous-access kit, laser irradiation therapy kit, patient positioning device for breast diagnostic imaging and radiotherapy, and patient positioning device for whole body diagnostic imaging and radiotherapy, among others.
The list also categorises a total of 75 radiotherapy devices in Class C, including various types of applicators for different brachytherapy devices, conformal brachytherapy source, high-frequency hyperthermia system, among others.
In Class D, there are 18 devices listed, including absorbable tissue spacer for radiotherapy, blood vessel manual brachytherapy applicator, central circulatory manual brachytherapy therapeutic radionuclide system, manual and remote after-loading coronary artery brachytherapy system applicator, among others.
The classification specifies 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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