{"id":50232,"date":"2022-10-21T12:30:44","date_gmt":"2022-10-21T07:00:44","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=50232"},"modified":"2024-11-04T17:58:32","modified_gmt":"2024-11-04T12:28:32","slug":"cdsco-registration-for-radiotherapy-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-radiotherapy-medical-devices\/","title":{"rendered":"CDSCO Registration for Radiotherapy Medical Devices &#8211; An Overview"},"content":{"rendered":"\n<p>Before 2006,\nthere was no such law governing the Medical Device Industry in India. The\ndevices had no regulation or licenses, which exposed the consumers to health\nand life risks. Later, the Central Drug Standard Control Organization made it\nmandatory for all medical devices to be regulated before they were sold or\nmarketed in India. CDSCO issued a notification on 3<sup>rd<\/sup> September\n2020, which notified 24 Medical devices for mandatory <strong><a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/cdsco-registration\">CDSCO registration<\/a><\/strong>. The list also\nincludes CDSCO Registration for Radiotherapy Medical Devices. <\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-radiotherapy-medical-devices\/#CDSCO_regulation_on_Medical_Devices_in_India\" >CDSCO regulation on Medical Devices in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-radiotherapy-medical-devices\/#Classification_of_Notified_Medical_Devices\" >Classification of Notified Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-radiotherapy-medical-devices\/#CDSCO_regulation_on_Radiotherapy_Medical_Devices\" >CDSCO regulation on Radiotherapy Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-radiotherapy-medical-devices\/#Documents_required_for_CDSCO_Registration_for_Radiotherapy_Medical_Devices\" >Documents required for CDSCO Registration for Radiotherapy Medical\nDevices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-radiotherapy-medical-devices\/#Procedure_for_CDSCO_Registration_for_Radiotherapy_Medical_Devices\" >Procedure for CDSCO Registration for Radiotherapy Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-radiotherapy-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CDSCO_regulation_on_Medical_Devices_in_India\"><\/span><strong>CDSCO regulation on Medical Devices in India<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>CDSCO has\nclassified Medical Devices into two broad categories based on Registration-<\/p>\n\n\n\n<ul>\n<li>Notified Medical Devices <\/li>\n\n\n\n<li>Non-Notified Medical Devices <\/li>\n<\/ul>\n\n\n\n<p>Until now, only Notified Medical Devices were supposed to get registered in India. There were 37 listed medical devices which required Registration in India. A Notification 648 (E) was issued by the Directorate General of Health and Services, which notified that the following medical devices are to be considered as <strong><a href=\"https:\/\/corpbiz.io\/drug-license\">drugs<\/a><\/strong> from 1<sup>st<\/sup> April 2020-<\/p>\n\n\n\n<p><em>\u2018All the devices that are Instruments, appliances,\napparatus, materials, implants or any other tool, which is used either alone or\nin combination with another device, software or accessory and Is used specially\nfor humans or animals, and do not achieve the primary intended action in or on\nanimal or human body by any Immunological or pharmacological or metabolic way,\nbut it may help in its intended function or for one or more specific purpose\nof-&#8221; <\/em><\/p>\n\n\n\n<ol>\n<li><em>Diagnosis, monitoring,&nbsp;\npreventing, alleviating or treating any kind of disorder or disease <\/em><\/li>\n\n\n\n<li><em>Diagnosis, monitoring,&nbsp;\npreventing, alleviating any Injury or disability<\/em><\/li>\n\n\n\n<li><em>Replacing, investigating, support or modifying of a physiological\nprocess or the anatomy<\/em><\/li>\n\n\n\n<li><em>Life support and sustaining <\/em><\/li>\n\n\n\n<li><em>Medical Device disinfection<\/em><\/li>\n\n\n\n<li><em>Conception control<\/em><\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_of_Notified_Medical_Devices\"><\/span><strong>Classification of Notified Medical Devices <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>CDSCO issued\nanother notification on 3<sup>rd<\/sup> September 2020 that notified 24 new\nmedical devices in the category of a notified medical device for mandatory\nRegistration. The Notification also mandated CDSCO Registration for\nRadiotherapy Medical Devices and 23 other medical devices. The devices notified\nin the list are mentioned below- <\/p>\n\n\n\n<figure class=\"wp-block-table table table-bordered\"><table><tbody><tr><td>\n  Sr. No.\n  <\/td><td>\n  Medical device Name\n  <\/td><\/tr><tr><td>\n  1\n  <\/td><td>\n  Anaesthesiology&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  2\n  <\/td><td>\n  Pain Management&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  3\n  <\/td><td>\n  Cardiovascular&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  4\n  <\/td><td>\n  Dental&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  5\n  <\/td><td>\n  Ear, Nose, Throat (ENT)&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  6\n  <\/td><td>\n  Gastroenterological&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  7\n  <\/td><td>\n  Urological&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  8\n  <\/td><td>\n  General Hospital&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  9\n  <\/td><td>\n  Operation Theater (O.T.)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  10\n  <\/td><td>\n  Respiratory&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  11\n  <\/td><td>\n  Neurological&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  12\n  <\/td><td>\n  Personnel use&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  13\n  <\/td><td>\n  Obstetrical and Gynaecological\n  (O.G.)\n  <\/td><\/tr><tr><td>\n  14\n  <\/td><td>\n  Ophthalmic&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  15\n  <\/td><td>\n  Rehabilitation&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  16\n  <\/td><td>\n  Physical support&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  17\n  <\/td><td>\n  Interventional and Radiology\n  <\/td><\/tr><tr><td>\n  18\n  <\/td><td>\n  Rheumatology&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  19\n  <\/td><td>\n  Dermatology and Plastic Surgery\n  <\/td><\/tr><tr><td>\n  20\n  <\/td><td>\n  Paediatric and Neonatology Medical\n  <\/td><\/tr><tr><td>\n  21\n  <\/td><td>\n  Oncology&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  <strong>22<\/strong>\n  <\/td><td>\n  <strong>Radiotherapy&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/strong>\n  <\/td><\/tr><tr><td>\n  23\n  <\/td><td>\n  Nephrology and Renal care&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  24\n  <\/td><td>\n  Software&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CDSCO_regulation_on_Radiotherapy_Medical_Devices\"><\/span><strong>CDSCO regulation on Radiotherapy Medical Devices <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Drugs Controller General of India notified on 6th August 2021 about the Classification of Radiotherapy under the <strong>Medical Device Rules, 2017<\/strong>. The Notification included 101 new devices in the list of CDSCO Registration for Radiotherapy Medical Devices. The following table mentions all the items listed in the Notification based on their class risks. <\/p>\n\n\n\n<figure class=\"wp-block-table table table-bordered\"><table><tbody><tr><td>\n  <strong>Sr.No.<\/strong>\n  <\/td><td>\n  <strong>MEDICAL\n  DEVICE NAME <\/strong>\n  <\/td><td>\n  <strong>RISK CLASS<\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>1<\/strong>\n  <\/td><td>\n  Medical charged\n  particle radiation therapy system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>2<\/strong>\n  <\/td><td>\n  Absorbable perirectal spacer\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>3<\/strong>\n  <\/td><td>\n  Absorbable\n  tissue spacer for radiotherapy\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>4<\/strong>\n  <\/td><td>\n  Applicator for bile duct manual\n  brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>5<\/strong>\n  <\/td><td>\n  Applicator for\n  bladder manual brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>6<\/strong>\n  <\/td><td>\n  Applicator for bladder remote\n  after loading brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>7<\/strong>\n  <\/td><td>\n  Applicator for\n  brachytherapy bile duct remote after loading\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>8<\/strong>\n  <\/td><td>\n  Applicator for brachytherapy\n  Cervical\/endometrial remote after loading\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>9<\/strong>\n  <\/td><td>\n  Applicator for\n  brachytherapy noncentral circulatory general-purpose manual\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>10<\/strong>\n  <\/td><td>\n  Applicator for brachytherapy\n  noncentral circulatory general-purpose remote after loading\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>11<\/strong>\n  <\/td><td>\n  Applicator for\n  bronchial manual brachytherapy applicator\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>12<\/strong>\n  <\/td><td>\n  Applicator for bronchial remote\n  after loading brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>13<\/strong>\n  <\/td><td>\n  Applicator for\n  esophagus manual brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>14<\/strong>\n  <\/td><td>\n  Applicator for esophagus remote\n  after loading brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>15 <\/strong>\n  <\/td><td>\n  Applicator for\n  eye manual brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>16<\/strong>\n  <\/td><td>\n  Applicator for manual\n  cervical\/endometrial brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>17<\/strong>\n  <\/td><td>\n  Applicator for\n  manual rectal\/anal brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>18<\/strong>\n  <\/td><td>\n  Applicator for nasopharynx\n  manual brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>19<\/strong>\n  <\/td><td>\n  Applicator for\n  nasopharynx remote after loading brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>20 <\/strong>\n  <\/td><td>\n  Applicator for neck manual\n  brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>21<\/strong>\n  <\/td><td>\n  Applicator for\n  neck remote after loading brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>22 <\/strong>\n  <\/td><td>\n  Applicator for pancreas manual\n  brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>23<\/strong>\n  <\/td><td>\n  Applicator for\n  pancreas remote after loading brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>24 <\/strong>\n  <\/td><td>\n  Applicator for prostate manual\n  brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>25<\/strong>\n  <\/td><td>\n  Applicator for\n  prostate remote after loading brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>26<\/strong>\n  <\/td><td>\n  Applicator for rectal\/anal\n  remote after loading brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>27 <\/strong>\n  <\/td><td>\n  Applicator for\n  tongue manual brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>28<\/strong>\n  <\/td><td>\n  Applicator for tongue remote\n  after loading brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>29 <\/strong>\n  <\/td><td>\n  Applicator for\n  vaginal manual brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>30<\/strong>\n  <\/td><td>\n  Applicator for vaginal remote\n  after loading brachytherapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>31<\/strong>\n  <\/td><td>\n  Bile duct\n  brachytherapy system applicator, remote-after loading\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>32<\/strong>\n  <\/td><td>\n  Bladder brachytherapy system applicator,\n  manual\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>33<\/strong>\n  <\/td><td>\n  Blood vessel\n  manual brachytherapy applicator\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>34<\/strong>\n  <\/td><td>\n  Blood vessel remote after\n  loading brachytherapy applicator\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>35 <\/strong>\n  <\/td><td>\n  Brachytherapy\n  needle\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>36<\/strong>\n  <\/td><td>\n  Brachytherapy radionuclide\n  phantom, anthropomorphic\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>37 <\/strong>\n  <\/td><td>\n  Brachytherapy\n  system chair\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>38<\/strong>\n  <\/td><td>\n  Brachytherapy system remote\n  after loading source safe\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>39<\/strong>\n  <\/td><td>\n  Brachytherapy\n  system remote after loading source transfer tube\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>40<\/strong>\n  <\/td><td>\n  Brain brachytherapy system\n  applicator, remote-after loading\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>41<\/strong>\n  <\/td><td>\n  Brain manual\n  brachytherapy applicator\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>42<\/strong>\n  <\/td><td>\n  Brain remote after loading\n  brachytherapy applicator\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>43 <\/strong>\n  <\/td><td>\n  Breast\n  ductography cannula\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>44<\/strong>\n  <\/td><td>\n  Central circulatory\n  general-purpose manual brachytherapy applicator\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>45<\/strong>\n  <\/td><td>\n  Central\n  circulatory general-purpose remote after loading brachytherapy applicator\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>46<\/strong>\n  <\/td><td>\n  Central circulatory manual\n  brachytherapy therapeutic radionuclide system\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>47<\/strong>\n  <\/td><td>\n  Central\n  circulatory permanent implant manual brachytherapy therapeutic radionuclide\n  source\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>48<\/strong>\n  <\/td><td>\n  Central circulatory remote after\n  loading brachytherapy therapeutic radionuclide source\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>49<\/strong>\n  <\/td><td>\n  Central\n  circulatory remote after loading brachytherapy therapeutic radionuclide\n  system\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>50<\/strong>\n  <\/td><td>\n  Central circulatory temporary\n  placement manual brachytherapy therapeutic radionuclide source\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>51<\/strong>\n  <\/td><td>\n  Compact\n  thermoluminescent dosimetry electrometer\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>52 <\/strong>\n  <\/td><td>\n  Conformal Brachytherapy Source\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>53 <\/strong>\n  <\/td><td>\n  High-frequency\n  hyperthermia system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>54<\/strong>\n  <\/td><td>\n  Intra-vaginal organ positioning\n  device for diagnostic imaging and radiotherapy\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>55 <\/strong>\n  <\/td><td>\n  Laser\n  irradiation therapy kit\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>56 <\/strong>\n  <\/td><td>\n  Light beam patient position\n  indicator\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>57 <\/strong>\n  <\/td><td>\n  Living tissue\n  radiotherapy system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>58<\/strong>\n  <\/td><td>\n  Manual radionuclide applicator\n  system\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>59<\/strong>\n  <\/td><td>\n  Medical neutron\n  radiation therapy system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>60<\/strong>\n  <\/td><td>\n  MOSFET radiation therapy\n  dosimetry system\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>61<\/strong>\n  <\/td><td>\n  Noncentral\n  circulatory manual brachytherapy therapeutic radionuclide system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>62<\/strong>\n  <\/td><td>\n  Noncentral circulatory permanent\n  implant manual brachytherapy therapeutic radionuclide source\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>63<\/strong>\n  <\/td><td>\n  Noncentral\n  circulatory remote after loading brachytherapy therapeutic radionuclide\n  source\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>64<\/strong>\n  <\/td><td>\n  Noncentral circulatory remote\n  after loading brachytherapy therapeutic radionuclide system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>65<\/strong>\n  <\/td><td>\n  Noncentral\n  circulatory temporary placement manual brachytherapy therapeuticradionuclide\n  source\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>66<\/strong>\n  <\/td><td>\n  Non-powered accelerator system\n  table\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>67 <\/strong>\n  <\/td><td>\n  Non-powered\n  neutron therapy table\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>68<\/strong>\n  <\/td><td>\n  Radionuclide brachytherapy table\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>69 <\/strong>\n  <\/td><td>\n  Non-powered\n  remote irradiation therapy table\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>70 <\/strong>\n  <\/td><td>\n  Non-powered X-rays radiation\n  therapy table\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>71 <\/strong>\n  <\/td><td>\n  Operator\n  radiation protection spectacles\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>72<\/strong>\n  <\/td><td>\n  Patient positioning device for\n  breast diagnostic imaging and radiotherapy\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>73<\/strong>\n  <\/td><td>\n  Patient\n  positioning device for extremity diagnostic imaging and radiotherapy\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>74<\/strong>\n  <\/td><td>\n  Patient positioning device for\n  pelvis diagnostic imaging and radiotherapy\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>75<\/strong>\n  <\/td><td>\n  Patient\n  positioning device for whole body diagnostic imaging and radiotherapy\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>76<\/strong>\n  <\/td><td>\n  Post Breast Biopsy Hemostatic\n  Breast Compression Device\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>77 <\/strong>\n  <\/td><td>\n  Powered neutron\n  therapy table\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>78 <\/strong>\n  <\/td><td>\n  Powered patient table for\n  accelerator\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>79<\/strong>\n  <\/td><td>\n  Powered\n  radiation therapy patient support assembly\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>80 <\/strong>\n  <\/td><td>\n  Powered radionuclide brachytherapy\n  table\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>81<\/strong>\n  <\/td><td>\n  Powered remote\n  irradiation therapy table\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>82 <\/strong>\n  <\/td><td>\n  Powered X-rays radiation therapy\n  table\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>83 <\/strong>\n  <\/td><td>\n  Radiation\n  therapy beam-shaping block\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>84 <\/strong>\n  <\/td><td>\n  Radiation therapy simulation\n  system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>85 <\/strong>\n  <\/td><td>\n  Radiographic\n  Protective Glove\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>86 <\/strong>\n  <\/td><td>\n  Radionuclide brachytherapy\n  source\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>87<\/strong>\n  <\/td><td>\n  Radionuclide\n  dynamic function testing equipment\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>88 <\/strong>\n  <\/td><td>\n  Radionuclide radiation therapy\n  system.\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>89<\/strong>\n  <\/td><td>\n  Radionuclide\n  source for remote irradiation therapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>90<\/strong>\n  <\/td><td>\n  Radionuclide system contour\n  detector for remote irradiation therapy\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>91<\/strong>\n  <\/td><td>\n  Real-time\n  position management respiratory gating system, optical\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>92 <\/strong>\n  <\/td><td>\n  Rectal balloon for prostate\n  immobilization\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>93<\/strong>\n  <\/td><td>\n  Remote\n  controlled radionuclide applicator system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>94 <\/strong>\n  <\/td><td>\n  Stationary radiation protection\n  barrier\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>95<\/strong>\n  <\/td><td>\n  Stereotactic\n  radiotherapy accelerator system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>96 <\/strong>\n  <\/td><td>\n  X-ray CT system for radiotherapy\n  planning\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>97<\/strong>\n  <\/td><td>\n  X-ray radiation\n  therapy system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>98<\/strong>\n  <\/td><td>\n  X-ray\/C.T. combined linear\n  accelerator system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>99<\/strong>\n  <\/td><td>\n  X-ray\/C.T.\n  combined particle radiotherapy equipment\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>100 <\/strong>\n  <\/td><td>\n  Patient Positioning System, Ultrasound\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>101<\/strong>\n  <\/td><td>\n  X-ray\/M.R.\n  combined linear accelerator system.\n  <\/td><td>\n  C\n  <\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_for_CDSCO_Registration_for_Radiotherapy_Medical_Devices\"><\/span><strong>Documents required for CDSCO Registration for Radiotherapy Medical\nDevices<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ol>\n<li>Application Form<\/li>\n\n\n\n<li>ISO 13485 Certificate <\/li>\n\n\n\n<li>Undertaking that only authentic\ndetails are provided <\/li>\n\n\n\n<li>TR6 Challan<\/li>\n\n\n\n<li>Power of attorney<\/li>\n\n\n\n<li>Full quality assurance\ncertificate <\/li>\n\n\n\n<li>Schedule D(I) <\/li>\n\n\n\n<li>C.E. Design certificate <\/li>\n\n\n\n<li>Declaration of conformity<\/li>\n\n\n\n<li>Plant master file <\/li>\n\n\n\n<li>Device master file <\/li>\n\n\n\n<li>Free sale certificate <\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_CDSCO_Registration_for_Radiotherapy_Medical_Devices\"><\/span><strong>Procedure for CDSCO Registration for Radiotherapy Medical Devices<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The steps to be\nfollowed for CDSCO Registration for Radiotherapy Medical Devices in India- <\/p>\n\n\n\n<ol>\n<li><strong>Identifying if Medical Devices require Registration or not<\/strong>: To obtain CDSCO registration, the applicant must first verify if\nthe Medical Device is notified or not. All the notified devices in India must\nbe registered before being marketed. All the Non-notified medical devices must\nobtain a voluntary registration before the given deadline based on their class\nrisks. The CDSCO Registration for Radiotherapy Medical Devices falls under the\nambit of notified medical devices, as notified by CDSCO.<\/li>\n\n\n\n<li><strong>Appointing Indian Authorized Agent (IAA):<\/strong> If the manufacturer who intends to apply for CDSCO Registration for\nRadiotherapy Medical Devices is not an Indian, then an Indian Authorized Agent\nis appointed to carry out official duties on his behalf as his representative. <\/li>\n\n\n\n<li><strong>Documentation process: <\/strong>The manufacturer\nor IAA must submit all the necessary documents and forms to the licensing\nauthorities to obtain &nbsp;CDSCO Registration\nfor Radiotherapy Medical Devices<\/li>\n\n\n\n<li><strong>Grant of Registration License: <\/strong>After\ncompleting the documentation, all the records are verified by the licensing\nauthority, and after fulfilling all the requirements, the registration\ncertificate is granted to the applicant. <\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><strong>Conclusion<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Medical Device Industry is increasing at a rapid scale, therefore it gets necessary to get CDSCO registration for medical devices to ensure product quality and safety to the customers on whom these medical devices are being used. However, the <strong><a href=\"https:\/\/corpbiz.io\/medical-device-registration\">medical device registration<\/a><\/strong> process might get technical in terms of rules and procedures. Therefore, it is always advisable to get help from professionals to obtain CDSCO registration certificate for medical devices to save from losses in terms of time and extra expenses. <\/p>\n\n\n\n<p class=\"text-left\"><b>Read Our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/registration-process-for-medical-devices-in-india\/\">A Step by Step guide for Registration Process for Medical Devices in India<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Before 2006, there was no such law governing the Medical Device Industry in India. The devices had no regulation or licenses, which exposed the consumers to health and life risks. Later, the Central Drug Standard Control Organization made it mandatory for all medical devices to be regulated before they were sold or marketed in India. [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":50239,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2800],"acf":{"service_id":"508"},"authorName":"Snehita Shukla","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-84.jpg","authorDescription":"Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate &amp; Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking  and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.","postViews":2867,"readingTime":6,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50232"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/45"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=50232"}],"version-history":[{"count":5,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50232\/revisions"}],"predecessor-version":[{"id":67125,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50232\/revisions\/67125"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/50239"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=50232"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=50232"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=50232"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}