This article deals with the latest rules of Radiotherapy as a Medical Device in India – Non Notified Medical Device Registration. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk-based classification lists for Radiotherapy and Medical Device in India. All Radiotherapy Products now need to be registered in order to comply with the latest Medical Device Rules in India ( i.e 30th September, 2021). Below is a table which helps manufacturers classify their products and apply with the Indian Health Ministry Accordingly. The total number of Devices classified are 101.
Table: Radiotherapy as Medical Device India
| Sr.No. | MEDICAL DEVICENAME | INTENDED USE | RISKCLASS |
| 1 | Medical charged-particle radiationtherapy system | A medical charged-particle radiation therapy system is adevice that produces by acceleration high energycharged particles (e.g., electrons and protons) intendedfor use in radiation therapy. | C |
| 2 | Absorbable perirectalspacer | An absorbable perirectal spacer is composed ofbiodegradable material that temporarily positions theanterior rectal wall away from the prostate duringradiotherapy for prostate cancer with the intent to reducethe radiation dose delivered to the anterior rectum. | C |
| 3 | Absorbable tissuespacer for radiotherapy | An absorbable material used to reduce radiationexposure of normal tissue during radiotherapy byimplanting surgically or percutaneously between tissue,internal organs, etc. , to make a space between themalignant tumor and normal tissue. | D |
| 4 | Applicator for bile ductmanual brachytherapy | A manual brachytherapy applicator specifically designedfor bile duct radiation therapy. An applicator designed tohave a configuration that facilitates manual placement(puncture or placement and removal using anendoscope or a diagnostic imaging system) of single ormultiple therapeutic radiation sources in treatment sitesin the bile duct. | C |
| 5 | Applicator for bladdermanual brachytherapy | A manual brachytherapy applicator designed to facilitatemanual placement (puncture or placement and removalusing an endoscope or a diagnostic imaging system) ofsingle or multiple therapeutic radiation sources intreatment sites in the bladder. | C |
| 6 | Applicator for bladderremote after loadingbrachytherapy | A remote controlled brachytherapy applicatorspecifically designed for bladder radiation therapy. It isdesigned to be temporarily implanted in the bladder. Itserves as a guide for computer-controlled temporaryplacement and removal of a single or multipletherapeutic radiation sources at treatment sites. | C |
| 7 | Applicator forbrachytherapy bile ductremote after loading | A remote controlled brachytherapy applicatorspecifically designed for bile duct radiation therapy. It isdesigned to be temporarily implanted in the bile duct. Itserves as a guide for computer-controlled temporaryplacement and removal of a single or multipletherapeutic radiation sources at treatment sites. | C |
| 8 | Applicator forbrachytherapyCervical/endometrialremote after loading | A remote controlled brachytherapy applicatorspecifically designed for uterine cervical or intrauterineradiation therapy. It is designed to be temporarilyimplanted in the body. It serves as a guide for computer-controlled temporary placement and removal of a singleor multiple therapeutic radiation sources in the uterinecervix and endometrium. | C |
| 9 | Applicator forbrachytherapy non-central circulatorygeneral-purposemanual | A general-purpose brachytherapy applicator used tofacilitate radiotherapy. A single or module applicatordesigned to facilitate manual placement (puncture, localplacement, placement under endoscopy, and placementand removal using an image diagnostic system) of singleor multiple therapeutic radiation sources in treatmentsites in the non-central circulatory system. | C |
| 10 | Applicator forbrachytherapy non-central circulatorygeneral-purposeremote after loading | A general-purpose remote controlled brachytherapyapplicator used to facilitate radiotherapy. It is designedto be temporarily implanted in the body. It serves as aguide for computer-controlled temporary placement andremoval of a single or multiple therapeutic radiationsources at treatment sites in the non-central circulatorysystem. | C |
| 11 | Applicator for bronchialmanual brachytherapyapplicator | A manual brachytherapy applicator specifically designedfor temporarily use in bronchial radiation therapy. Asingle or module applicator designed to facilitate manualplacement (placement using an endoscope orpositioning, placement and removal using a diagnosticimaging system) of single or multiple therapeuticradiation sources in treatment sites. It may be designedto be standard in configuration or to handle specificradiation sources. | C |
| 12 | Applicator for bronchialremote after loadingbrachytherapy | A remote controlled brachytherapy applicatorspecifically designed for bronchial radiation therapy. It isdesigned to be temporarily implanted in the body. Itserves as a guide for computer-controlled temporaryplacement and removal of a single or multipletherapeutic radiation sources in the bronchus. Thisdevice group includes various applicators such ashollow needles, tubes, and catheters, as well asassociated devices and connectors. | C |
| 13 | Applicator foresophagus manualbrachytherapy | A manual brachytherapy applicator specifically designedfor esophagus radiation therapy. A single or moduleapplicator designed to facilitate manual placement(puncture or placement and removal using anendoscope or a diagnostic imaging system) of single ormultiple therapeutic radiation sources in treatment sitesin the esophagus. It may be designed to be standard inconfiguration or to handle specific radiation sources. | C |
| 14 | Applicator foresophagus remote afterloading brachytherapy | A remote controlled brachytherapy applicatorspecifically designed for esophagus radiation therapy. Itis designed to be temporarily implanted in theesophagus. It serves as a guide for computer-controlledtemporary placement and removal of a single or multipletherapeutic radiation sources. This device groupincludes various applicators such as hollow needles,tubes, and catheters, as well as associated devices andconnectors. | C |
| 15 | Applicator for eyemanual brachytherapy | A template with a groove on the one side. The grooveshows the position of the brachytherapy source that ismanually, temporarily delivered to the eye surface. Theother side is shielded. | C |
| 16 | Applicator for manualcervical/endometrialbrachytherapy | A manual brachytherapy applicator specifically designedfor uterine cervix or intrauterine radiation therapy. Asingle or module applicator designed to facilitate manualplacement (puncture, placement with an endoscope or adiagnostic imaging system) of single or multipletherapeutic radiation sources in treatment sites. | C |
| 17 | Applicator for manualrectal/analbrachytherapy | A manual brachytherapy applicator specifically designedfor rectal and/or anal radiation therapy. A single ormodule applicator designed to facilitate manualplacement (puncture or placement and removal using anendoscope or a diagnostic imaging system) of single ormultiple therapeutic radiation sources in treatment sitesin the rectum and/or anus. | C |
| 18 | Applicator fornasopharynx manualbrachytherapy | A manual brachytherapy applicator specifically designedfor nasopharyngeal radiation therapy. A single ormodule applicator designed to facilitate manualplacement (puncture, endoscopic placement orplacement and removal using a diagnostic imagingsystem) of single or multiple therapeutic radiationsources in treatment sites in the nasopharynx. | C |
| 19 | Applicator fornasopharynx remoteafter loadingbrachytherapy | A remote controlled brachytherapy applicatorspecifically designed for nasopharyngeal radiationtherapy. It is designed to be temporarily implanted in thebody. It serves as a guide for computer-controlledtemporary placement and removal of a single or multipletherapeutic radiation sources in the nasopharynx. | C |
| 20 | Applicator for neckmanual brachytherapy | A manual brachytherapy applicator specifically designedfor neck radiation therapy. A single or module applicatordesigned to facilitate manual placement (puncture, localplacement or placement and removal using a diagnosticimaging system) of single or multiple therapeuticradiation sources in treatment sites in the neck tissues. | C |
| 21 | Applicator for neckremote after loadingbrachytherapy | A remote controlled brachytherapy applicatorspecifically designed for neck radiation therapy. It isdesigned to be temporarily implanted in the neck tissues.It serves as a guide for computer-controlled temporaryplacement and removal of a single or multipletherapeutic radiation sources. | C |
| 22 | Applicator for pancreasmanual brachytherapy | A manual brachytherapy applicator specifically designedfor pancreatic radiation therapy. A single or moduleapplicator designed to facilitate manual placement(puncture, endoscopic placement, or placement andremoval using a diagnostic imaging system) of single ormultiple therapeutic radiation sources in treatment sitesin the pancreas. It may be designed to be standard inconfiguration or to handle specific radiation sources. | C |
| 23 | Applicator for pancreasremote after loadingbrachytherapy | A remote controlled brachytherapy applicatorspecifically designed for pancreatic radiation therapy. Itis designed to be temporarily implanted in the pancreas.It serves as a guide for computer-controlled temporaryplacement and removal of a single or multipletherapeutic radiation sources at treatment sites. | C |
| 24 | Applicator for prostatemanual brachytherapy | A manual brachytherapy applicator specifically designedfor prostate radiation therapy. A single or moduleapplicator designed to facilitate manual placement(puncture or placement or removal with a trigger loadingdevice, an endoscope or a diagnostic imaging system)of single or multiple therapeutic radiation sources intreatment sites in the prostate gland. It may be designedto be standard in configuration or to handle specificradiation sources. | C |
| 25 | Applicator for prostateremote after loadingbrachytherapy | A remote controlled brachytherapy applicatorspecifically designed for prostate radiation therapy. It isdesigned to be temporarily implanted in the prostategland. It serves as a guide for computer-controlledtemporary placement and removal of a single or multipletherapeutic radiation sources. | C |
| 26 | Applicator forrectal/anal remote afterloading brachytherapy | A remote controlled brachytherapy applicatorspecifically designed for rectal or anal radiation therapy.It is designed to be temporarily implanted in the rectumor anus. It serves as a guide for computer-controlledtemporary placement and removal of a single or multipletherapeutic radiation sources. | C |
| 27 | Applicator for tonguemanual brachytherapy | A manual brachytherapy applicator specifically designedfor lingual radiation therapy. A single or moduleapplicator designed to facilitate manual placement(puncture, local placement or placement and removalusing a diagnostic imaging system) of single or multipletherapeutic radiation sources in treatment sites in thetongue and the surrounding tissues. It may be designedto be standard in configuration or to handle specificradiation sources. | C |
| 28 | Applicator for tongueremote after loadingbrachytherapy | A remote controlled brachytherapy applicatorspecifically designed for tongue or oral cavity radiationtherapy. It is designed to be temporarily implanted in thetongue or the surrounding tissues. It serves as a guidefor computer-controlled temporary placement andremoval of a single or multiple therapeutic radiationsources. | C |
| 29 | Applicator for vaginalmanual brachytherapy | A manual brachytherapy applicator specifically designedfor vaginal or transvaginal radiation therapy. A single ormodule applicator designed to facilitate manualplacement (puncture, local placement, endoscopicplacement or placement and removal using a diagnosticimaging system) of single or multiple therapeuticradiation sources in treatment sites. | C |
| 30 | Applicator for vaginalremote after loadingbrachytherapy | A remote controlled brachytherapy applicatorspecifically designed for vaginal or transvaginal radiationtherapy. It is designed to be temporarily implanted in thebody. It serves as a guide for computer-controlledtemporary placement and removal of a single or multipletherapeutic radiation sources in the vagina. | C |
| 31 | Bile duct brachytherapysystem applicator,remote-after loading | A remote after loading brachytherapy applicatorspecifically designed for use in radiation therapytreatments of the bile duct. It is designed for temporaryinsertion into the bile duct and serve as a guide forcomputer-controlled placement and removal of single ormultiple radioactive sources. | C |
| 32 | Bladder brachytherapysystem applicator,manual | A manual brachytherapy applicator specifically designedto be used in radiation therapy treatments of the bladder. | C |
| 33 | Blood vessel manualbrachytherapyapplicator | A manual brachytherapy applicator designed exclusivelyfor blood vessel radiotherapy. Most commonly, it is usedto prevent formation of plaque, stenosis and restenosisin blood vessels after surgery. A single or module devicedesigned to facilitate manual placement (placement andremoval under endoscopy or using an image diagnosticsystem) of single or multiple therapeutic radiationsources in the treatment site. | D |
| 34 | Blood vessel remoteafter loadingbrachytherapyapplicator | A remote controlled brachytherapy applicator designedexclusively for radiotherapy in blood vessels. Thistreatment is used to prevent plaque formation. andstenosis in blood vessels after surgery. It is designed fortemporary implantation in a blood vessel, and serves asa guide for computer-controlled temporary placementand removal of single or multiple therapeutic radiationsources at treatment sites. | D |
| 35 | Brachytherapy needle | A sterile, sharp bevel-edged, hollow tubular metalinstrument that is used to inject radionuclide into a bodycavity or tissue as a source of nuclear radiation forcancer therapy (brachytherapy). | B |
| 36 | Brachytherapyradionuclide phantom,anthropomorphic | A device that consists of preserved human or animaltissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to simulate the functional,physical, or a combination of these characteristics ofnormal or diseased human organs. | B |
| 37 | Brachytherapy systemchair | A mains electricity (AC-powered) device (a chair orstool) that is a component of a brachytherapy systemand which is specifically designed to support andposition a patient during brachytherapy radiationtreatments given by either a manual applicator or aremote after loading brachytherapy system applicator. | B |
| 38 | Brachytherapy systemremote after loadingsource safe | A component of a remote after loading brachytherapysystem consisting of a shielded vault, and associatedsource retraction and extrusion mechanisms, alarms,and related mechanical, electronic and softwarecontrols, used to shield the brachytherapy sources inorder to protect system operators, brachytherapypatients and others from the continuous emissions of theradioactive brachytherapy source(s) when they are notin use. | C |
| 39 | Brachytherapy systemremote after loadingsource transfer tube | The transfer tube, when attached to the applicator andthe after loading system, provides a continuous closedpassage that allows for moving either a radioactivesource(s) and/or positioning markers from the shieldedsource storage compartment of the remote after loadingbrachytherapy system into appropriate positions within abrachytherapy applicator that has been positioned at alocation either on the surface of, or within, the patient. | C |
| 40 | Brain brachytherapysystem applicator,remote-after loading | A remote after loading brachytherapy applicatorspecifically designed for use in radiation therapytreatments of the brain. It is designed for temporaryimplantation within the body and serve as a guide forcomputer-controlled placement and removal of single ormultiple radioactive sources in the brain. | C |
| 41 | Brain manualbrachytherapyapplicator | An applicator specifically designed for brainradiotherapy. A single or module applicator designed tofacilitate manual placement (puncture, placement underendoscopy, or placement and removal using an imagediagnostic system) of single or multiple therapeuticradiation sources in the brain. | D |
| 42 | Brain remote afterloading brachytherapyapplicator | A remote controlled brachytherapy applicator designedexclusively for brain radiotherapy for temporaryimplantation in the body. It serves as a computer-controlled guide for temporary placement and removalof a single or multiple therapeutic radiation sources inthe brain. | D |
| 43 | Breast ductographycannula | A thin, sterile, semi-rigid or rigid metal tube that isinserted into the nipple of the female breast to inject acontrast medium into the lactiferous ducts to enhancetheir visualization during a radiographic procedure. | C |
| 44 | Central circulatorygeneral-purposemanual brachytherapyapplicator | A single or module applicator designed to facilitatemanual placement (puncture, local placement,placement under endoscopy or placement and removalusing an image diagnostic system) of single or multipletherapeutic radiation sources in treatment sites in thecentral circulatory system. | D |
| 45 | Central circulatorygeneral-purposeremote after loadingbrachytherapyapplicator | Intended to be temporarily implanted in the body. Itserves as a guide for computer-controlled temporaryplacement and removal of a single or multipletherapeutic radiation sources at treatment sites in thecentral circulatory system. | D |
| 46 | Central circulatorymanual brachytherapytherapeuticradionuclide system | A device that places a radiation source manually orautomatically at the treatment site in the centralcirculatory system for providing a required radiationdose during radiotherapy. This device does not equip aremotely controlled radiation source transporter. | D |
| 47 | Central circulatorypermanent implantmanual brachytherapytherapeuticradionuclide source | A device for the central circulatory system to be placedpermanently in the body for radiotherapy which isnecessary for treatment and symptomatic therapy, anduses natural radioisotopes or radioisotopes produced byan accelerator or a nuclear reactor. The radiationsource, which is permanently placed manually, isdesigned to achieve compatibility with tissues. Theradiation source can be selected from the followingforms – e.g., microsphere, globe, stent, seed, and wire-in order to generate low-energy photons, beta particles,or alpha particles. | D |
| 48 | Central circulatoryremote after loadingbrachytherapytherapeuticradionuclide source | A device for the central circulatory system used asradiation source to deliver a high or low dose rate withan after-loading brachytherapy device designed forradiotherapy which is necessary for treatment andsymptomatic therapy, and uses natural radioisotopes orradioisotopes produced by an accelerator or a nuclearreactor. | D |
| 49 | Central circulatoryremote after loadingbrachytherapytherapeuticradionuclide system | A device that places a radiation source temporarily at thetreatment site in the central circulatory system forproviding a required radiation dose during radiotherapy.This device equips a remotely controlled radiationsource transporter. | D |
| 50 | Central circulatorytemporary placementmanual brachytherapytherapeuticradionuclide source | A device for the central circulatory system that usesnatural radioisotopes or radioisotopes produced by anaccelerator or a nuclear reactor, and is placed in thebody temporarily, and removed after the pre-determinedtreatment period. The radiation source, which istemporarily inserted manually, is supplied in variousforms – e.g., encapsulated, sealed, plated, foiled, orembedded. | D |
| 51 | Compactthermoluminescentdosimetry electrometer | Thermoluminescence dosimeter (TLD) is used tomeasure the radiation dose emitted to the phantom,eyes and other organs with high radio sensitivity. | A |
| 52 | ConformalBrachytherapy Source | The intended use of the device is for the treatment ofcancer by temporary intraoperative or surfaceirradiation. The device contains radioactive material withactivity up to 200 mci and is indicated for treatment oftemporary intraoperative, interstitial, intracavitary orsurface application to treat selected localized tumors. | C |
| 53 | High-frequencyhyperthermia system | A system used to generate high-temperatures and tocontrol the provision of heat to the body in the treatmentof malignant and benign tumors, or other diseases. | C |
| 54 | Intra-vaginal organpositioning device fordiagnostic imaging andradiotherapy | A device that is specifically designed to be inserted inthe vagina to properly position and fix the surroundingorgans such as uterine cervix, rectum, and urinarybladder for image diagnosis or radiotherapy. This deviceis used to facilitate reproducible positioning forcontinuous image examination or continuousradiotherapy. | B |
| 55 | Laser irradiationtherapy kit | A kit includes a puncture needle, a guide wire, and aguiding sheath for guiding probes (used for laserirradiation therapy, for example). Not all of thecomponents are included; in some products, two or moreof components are integrated into one. | B |
| 56 | Light beam patientposition indicator | A light beam patient position indicator is a device thatprojects a beam of light (incoherent light or laser) todetermine the alignment of the patient with a radiationbeam. | A |
| 57 | Living tissueradiotherapy system | A low energy X-ray therapy system designed to treatadjacent tumor lesions with high dose X-rays by placingsoft X-ray beams from 5 to 50 kV inside the tumor tissue.It is used in both intraoperative radiation and stereotacticlocalized radiation therapy. | C |
| 58 | Manual radionuclideapplicator system | A manual radionuclide applicator system is a manuallyoperated device intended to apply a radionuclide sourceinto the body or to the surface of the body for radiationtherapy. | A |
| 59 | Medical neutronradiation therapysystem | A medical neutron radiation therapy system is a deviceintended to generate high-energy neutrons for radiationtherapy | C |
| 60 | MOSFET radiationtherapy dosimetrysystem | An assembly of devices using metal oxidesemiconductor field-effect transistor (MOSFET)technology intended to be used for on-the-spot patientor anthropomorphic radiation dose verification andmonitoring during radiation therapy and radiologyprocedures. Applications typically include radiationoncology therapy and dosimetry, treatment planverification for in vivo dosimetry, brachytherapy,intraoperative radiation therapy, image-guided radiationtherapy, and research. | B |
| 61 | Non-central circulatorymanual brachytherapytherapeuticradionuclide system | A device that places a radiation source manually orautomatically at the treatment site in the non-centralcirculatory system for providing a required radiationdose during radiotherapy. | C |
| 62 | Non-central circulatorypermanent implantmanual brachytherapytherapeuticradionuclide source | A non-central cardiovascular device which ishistocompactible and containing an isotope naturallyoccurring or produced by an accelerator or a nuclearreactor, intended to be permanently implanted in thebody for radiation therapy requiring treatment orsymptomatic treatment. | C |
| 63 | Non-central circulatoryremote after loadingbrachytherapytherapeuticradionuclide source | A device for the non-central circulatory system used asradiation source to deliver a high or low dose rate withan after-loading brachytherapy device designed forradiotherapy which is necessary for treatment andsymptomatic therapy, and uses natural radioisotopes orradioisotopes produced by an accelerator or a nuclearreactor. | C |
| 64 | Non-central circulatoryremote after loadingbrachytherapytherapeuticradionuclide system | A device that places a radiation source temporarily at thetreatment site in the non-central circulatory system forproviding a required radiation dose during radiotherapy.This device equips a remotely controlled radiationsource transporter. | C |
| 65 | Non-central circulatorytemporary placementmanual brachytherapytherapeuticradionuclide source | A non-central cardiovascular device containing anisotope naturally occurring or produced by anaccelerator or a nuclear reactor, intended to betemporarily implanted in the body and to be removedafter a prescribed duration of treatment. Used inbrachytherapy, the device is placed and removedmanually or under endoscopic observation. | C |
| 66 | Non-poweredaccelerator systemtable | A mechanically-operated bed for radiotherapy designedto adjust the patient’s posture and immobilize the patientfor radiotherapy that uses a medical linear accelerator ornon-linear accelerator. | A |
| 67 | Non-powered neutrontherapy table | A bed for radiotherapy designed to adjust the patient’sposture and immobilize the patient for treatment thatuses neutron rays that are generated from a nuclearreactor, etc. It is equipped with a table top that fixes theposture, pneumatic control, magnetic lock, crank, andlever for mechanical table top positioning control andtable height control. | A |
| 68 | Radionuclidebrachytherapy table | A programmable bed for electric radiotherapy to adjustthe patient’s posture and immobilize the patient fortreatment that uses an after loading short-distanceirradiation treatment apparatus that is operatedmanually or electrically. | B |
| 69 | Non-powered remoteirradiation therapy table | A bed for radiotherapy designed to adjust the patient’sposture and immobilize the patient for treatment thatuses a remote radionuclide radiotherapy apparatus. | A |
| 70 | Non-powered X-raysradiation therapy table | A bed for radiotherapy designed to adjust the patient’sposture and immobilize the patient for treatment thatuses an X-ray therapy apparatus. | A |
| 71 | Operator radiationprotection spectacles | A personal protection device that protects the eyes ofthe operator and other personnel from unnecessaryexposure to primary radiation and scattered radiationassociated with diagnosis and treatment. | B |
| 72 | Patient positioningdevice for breastdiagnostic imaging andradiotherapy | A device that is specifically designed to properly positionand fix a female patient’s breasts and chest for imagediagnosis, image-guided surgery, interventional therapy,or radiotherapy. | B |
| 73 | Patient positioningdevice for extremitydiagnostic imaging andradiotherapy | A device that is specifically designed to properly positionand fix a patient’s arms and legs for image diagnosis,image-guided surgery, interventional therapy, orradiotherapy. | B |
| 74 | Patient positioningdevice for pelvisdiagnostic imaging andradiotherapy | The device that consists of frames, plates, or other parts,and is specifically designed to properly position and fixthe patient’s abdomen and pelvic region for imagediagnosis, image-guided surgery, interventional therapy,or radiotherapy. | B |
| 75 | Patient positioningdevice for whole bodydiagnostic imaging andradiotherapy | A device that consists of fixed or adjustable parts (e.g.,frames and plates), and is specifically designed toproperly position and fix the patient’s whole body forimage diagnosis, image-guided surgery, interventionaltherapy, or radiotherapy. | B |
| 76 | Post Breast BiopsyHemostatic BreastCompression Device | Intended to achieve and maintain hemostasis of a breastbiopsy wound site. | C |
| 77 | Powered neutrontherapy table | A programmable bed for radiotherapy designed to adjustthe patient’s posture and immobilize the patient fortreatment that uses neutron rays that are generated fromthe nuclear reactor, etc. | B |
| 78 | Powered patient tablefor accelerator | A bed operates by programmable for electricradiotherapy designed to adjust the patient’s postureand immobilize the patient for radiotherapy that usesmedical linear accelerator or non-linear accelerator. | B |
| 79 | Powered radiationtherapy patient supportassembly | A powered radiation therapy patient support assembly isan electrically powered adjustable couch intended tosupport a patient during radiation therapy | C |
| 80 | Powered radionuclidebrachytherapy table | A programmable bed for radiotherapy designed to adjustthe patient’s posture and immobilize the patient fortreatment that uses an after loading short-distanceirradiation treatment apparatus that is operatedmanually or electrically. | B |
| 81 | Powered remoteirradiation therapy table | A programmable electrically operated bed forradiotherapy designed to adjust the patient’s postureand immobilize the patient for treatment that uses aremote cobalt 60 radiotherapy apparatus and otherremote radionuclide radiotherapy apparatuses. | B |
| 82 | Powered X-raysradiation therapy table | A programmable electrically operated bed forradiotherapy designed to adjust the patient’s postureand immobilize the patient for treatment that uses an X-ray therapy apparatus. | B |
| 83 | Radiation therapybeam-shaping block | A radiation therapy beam-shaping block is a devicemade of a highly attenuating material (such as lead)intended for medical purposes to modify the shape of abeam from a radiation therapy source | C |
| 84 | Radiation therapysimulation system | A radiation therapy simulation system is a fluoroscopicor radiographic x-ray system intended for use inlocalizing the volume to be exposed during radiationtherapy and confirming the position and size of thetherapeutic irradiation field produced. | C |
| 85 | RadiographicProtective Glove | A personnel protective glove is a device intended formedical purposes to protect the patient, the operator, orother persons from unnecessary exposure to radiationduring radiologic procedures by providing an attenuatingbarrier to radiation | B |
| 86 | Radionuclidebrachytherapy source | A radionuclide brachytherapy source is a device thatconsists of a radionuclide which may be enclosed in asealed container made of gold, titanium, stainless steel,or platinum and intended for medical purposes to beplaced onto a body surface or into a body cavity or tissueas a source of nuclear radiation for therapy | C |
| 87 | Radionuclide dynamicfunction testingequipment | A device used to measure and record temporalvariations of radioisotope concentrations in the body.Specialized devices, such as devices for thyroid uptakemeasurement, renograms, and radioisotope bloodvolume measurement, are included. | B |
| 88 | Radionuclide radiationtherapy system. | A radionuclide radiation therapy system is a deviceintended to permit an operator to administer gammaradiation therapy, with the radiation source located at adistance from the patient’s body. | C |
| 89 | Radionuclide source forremote irradiationtherapy | Radiation sources generated in a reactor and used as ina remote after loading system designed to deliver atherapeutic radiation beam to a target anatomical area.The radiation sources incorporated as a component ofthe remote after loading system are generally sealed. | C |
| 90 | Radionuclide systemcontour detector forremote irradiationtherapy | Intended to precisely determine the outline of the area ofthe body to be irradiated. Usually, the informationobtained from this device is entered into a radiotherapyplanning system and utilized for the radiotherapy plan. | C |
| 91 | Real-time positionmanagementrespiratory gatingsystem, optical | An assembly of electronic devices designed to track therespiratory pattern of a patient by means of opticaltechnology to correlate tumour position with therespiratory cycle during radiation treatment planning,radiotherapy, computed tomography (CT) imaging, orother radiation procedures. | C |
| 92 | Rectal balloon forprostate immobilization | A rectal balloon for prostate immobilization is a singleuse, inflatable, non-powered positioning device placedin the rectum to immobilize the prostate in patientsundergoing radiation therapy. | C |
| 93 | Remote controlledradionuclide applicatorsystem | A remote controlled radionuclide applicator system is anelectromechanical or pneumatic device intended toenable an operator to apply, by remote control, aradionuclide source into the body or to the surface of thebody for radiation therapy. | C |
| 94 | Stationary radiationprotection barrier | A device for permanent installation that forms astructural barrier that shields or attenuates radiationemitted from primary radiation source or scatteredradiation source. | B |
| 95 | Stereotacticradiotherapyaccelerator system | A stereotactic radiation therapy system for treatmentbased on a linear accelerator (or microtron). The devicemay be used to inactivate lymphocytes. | C |
| 96 | X-ray CT system forradiotherapy planning | A X-ray CT system that has a special configuration,containing hardware, software, etc. used in radiotherapyplanning. It is used to determine the size and positioningof the therapeutic radiation field based on a series oftreatment parameters to be generated. | C |
| 97 | X-ray radiation therapysystem | An x-ray radiation therapy system is a device intendedto produce and control x-rays used for radiation therapy. | C |
| 98 | X-ray/CT combinedlinear acceleratorsystem | A combined system of a linear accelerator system andan X-ray CT system for radiotherapy planning. | C |
| 99 | X-ray/CT combinedparticle radiotherapyequipment | A combined system of particle radiotherapy equipmentand an X-ray CT system for radiotherapy planning. | C |
| 100 | Patient PositioningSystem, Ultrasound | An assembly of devices used to locate, with ultrasound,internal soft-tissue anatomy that moves relative toexternal or bony landmarks, to enable subsequentadjustment of the patient for precise external beamradiation treatment of the target tissue. It typicallyincludes an ultrasound imaging system, computerizedworkstation(s), optical tracking devices, and dedicatedsoftware. | C |
| 101 | X-ray/MR combinedlinear acceleratorsystem. | A system intended to provide treatment planning, image-guided stereotactic radiosurgery and precisionradiotherapy for lesions, tumors and conditionsanywhere in the body where radiation treatment inindicated. The system operates on the principle of linearacceleration of electrons, providing a predictableradiation field in a beam of well-defined dimensions | C |
Conclusion:
The above article is taken from S.O 648(E) & G.S.R 102(E) which mentions that all Medical Devices will be regulated in a phase manner. The CDSCO has classified the MDR in India as Appendix A based on the Intended Use, Risks Associated and Other Parameters Specified with the device. The above table has the general intended use against each device, however if any specific intended use for a particular device, it has to be mentioned by the manufacturer. The list is dynamic and is subject to changes. To obtain MDR in India, contact Morulaa. We at Morulaa will help you understand the latest rules for Radiotherapy as a Medical Device India. In order to comply with the Deadline 30th September of Radiotherapy as a Medical Device in India contact us at admin@morulaa.com. You can also subscribe to our website to learn about the Latest Rules and Medical Regulations.
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