New Delhi: In a move to streamline regulatory oversight of medical devices, the Central Drugs Standard Control Organisation (CDSCO) has released the official risk classification list for medical devices used in Radiotherapy.The notification, issued on November 26, 2025, follows the draft list published earlier this year and has been finalized under the authority granted by the Medical Devices Rules (MDR), 2017.According to the notice issued, consequent to the publication of the draft list vide File No. MED-16014(12)/1/2024- eoffice dated 06.01.2025, and in exercise of the powers conferred under subrule(3) of Rule 4 of the Medical Devices Rules, 2017, the classification of the medical devices pertaining to Radiotherapy has been done under the Medical Devices Rules, 2017.As per the Medical Device Rule, 2017, medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, into the following classes:—(i) low risk-Class A;(ii) low moderate risk-Class B;(iii) moderate high risk-Class C;(iv) high risk-Class DThe finalized list, provided in Appendix A of the notice, outlines the risk classification for various interventional radiology devices, and it is subject to the following:1. General intended use given against each of the devices is for the guidance of the applicants who intend to furnish applications for manufacturing/import of medical devices under the Medical Devices Rules, 2017. However, a device may have a specified intended use as specified by its manufacturer.2. This list is dynamic and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017.Classification of Medical Devices Pertaining to RadiotherapyS.No.Device nameIntended UseRisk Classification1Absorbable perirectal spacerAn absorbable perirectal spacer is composed of biodegradable material and intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum.Class D2Absorbable tissue spacer for radiotherapyAn absorbable material intended to reduce radiation exposure of normal tissue during radiotherapy by implanting surgically or percutaneously between tissue, internal organs,etc., to make a space between the malignant tumour and normal tissue.Class D3Accelerator system computerA dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software used specifically to control and monitor the operation of a linear or non-linear medical accelerator system and associatedprocessing, display and analysis functions.Class C4Accelerator system operator consoleA device that is a component of a linear or a non- linear accelerator system and intended to function as the primary control panel typically for a therapeutic-use betatron or cyclotron system.Class C5Applicator for bile duct manual brachytherapyA manual brachytherapy applicator specifically intended to facilitate manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multipletherapeutic radiation sources in treatment sites in the bile duct.Class C6Applicator for bile duct remote after loading brachytherapyA remote-controlled brachytherapy applicator specifically intended to be temporarily implanted in the bile duct. It serves as a guide for computer- controlled temporary placement and removal of a single or multiple therapeutic radiation sources attreatment sites.Class C7Applicator for bladder manual brachytherapyA manual brachytherapy applicator intended to facilitate manual placement (puncture or placement and removal using an endoscope or a diagnostic imaging system) of single or multiple therapeutic radiation sources in treatment sites in the bladder.Class C8Applicator for bladder remote after loading brachytherapyA remote-controlled brachytherapy applicator specifically intended to be temporarily implanted in the bladder and serves as a guide for computer- controlled temporary placement and removal of a single or multiple therapeutic radiation sources at treatment sites.Class C9Applicator for brachytherapy non- central circulatory general- purpose, manualA general-purpose brachytherapy applicator intended to facilitate manual placement (puncture, local placement, placement under endoscopy, and placement and removal using an image diagnostic system) of single or multiple therapeutic radiation sources in treatment sites in the non-central circulatory system.Class C10Applicator for brachytherapy non- central circulatory general- purpose remote, after loadingA general-purpose remote controlled brachytherapy applicator intended to be temporarily implanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a single or multipletherapeutic radiation sources at treatment sites…

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