{"id":50674,"date":"2022-11-15T12:45:01","date_gmt":"2022-11-15T07:15:01","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=50674"},"modified":"2023-04-10T17:37:25","modified_gmt":"2023-04-10T12:07:25","slug":"cdsco-registration-for-interventional-and-radiology-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-interventional-and-radiology-medical-devices\/","title":{"rendered":"CDSCO Registration for Interventional and Radiology Medical Devices &#8211; An Overview"},"content":{"rendered":"\n<p>In\nIndia, medical experts use interventional radiology techniques to diagnose\n&amp; treat diseases. Medical experts can treat so many medical conditions\nthrough interventional radiology. In this medical technique, medical experts\ninsert some same tools into the body, such as catheters or wire for different\nmachines such as CT Scan, X-ray, and Ultrasound Machines. This interventional\nradiology can be an alternate option for surgery for different medical\nconditions and it also reduces the hospitalisation period for patients. In this\nwrit, we will discuss CDSCO Registration for Interventional and Radiology\nMedical 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-interventional-and-radiology-medical-devices\/#Risk-Based_Classification_of_Medical_Devices\" >Risk-Based\nClassification of Medical Devices<\/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-interventional-and-radiology-medical-devices\/#Classification_of_Medical_Devices_Pertaining_to_Interventional_and_Radiology\" >Classification\nof Medical Devices Pertaining to Interventional and Radiology<\/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-interventional-and-radiology-medical-devices\/#Documents_Required_for_CDSCO_Registration_for_Interventional_and_Radiology_Medical_Devices\" >Documents\nRequired for CDSCO Registration for Interventional and Radiology Medical\nDevices<\/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-interventional-and-radiology-medical-devices\/#Procedure_for_CDSCO_Registration_for_Interventional_and_Radiology_Medical_Devices\" >Procedure for\nCDSCO Registration for Interventional and Radiology Medical Devices<\/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-interventional-and-radiology-medical-devices\/#Post-Compliance_after_Getting_CDSCO_Registration_for_Interventional_and_Radiology_Medical_Devices\" >Post-Compliance\nafter Getting CDSCO Registration for Interventional and Radiology Medical\nDevices<\/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-interventional-and-radiology-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Risk-Based_Classification_of_Medical_Devices\"><\/span>Risk-Based\nClassification of Medical Devices <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On\n3<sup>rd<\/sup> September 2020, CDSCO released a draft classification for\nNon-Notified Medical Devices. The Ministry of Health &amp; Family Welfare is\ngoing to classify non-notified medical devices such as gowns, adhesive drapes,\nand cover all under Class A, and surgical drapes &amp; Non-Notified <strong><em>In-vitro\nDiagnostics (IVD) <\/em><\/strong>as Class B Medical Devices. In Feb 2020, the Ministry\nof Health &amp; Family Welfare made a great move by releasing the Medical\nDevice definition &amp; inclusion of Chapter III A under MDR, 2017. This led\nall Manufacturers &amp; Importers to register the Non-Notified Medical Devices\nwith the CDSCO, effective from 1<sup>st<\/sup> April 2020.<\/p>\n\n\n\n<p>According\nto the <strong><em>Medical Device Rules 2017 Chapter II Rule (3)<\/em><\/strong>, the Central\nLicensing Authority (CLA) for Medical Devices, the Medical Devices\nclassification should be based on risk such as:<\/p>\n\n\n\n<ul><li><strong>Low\nRisk \u2013 Class A<\/strong><\/li><li><strong>Low\nModerate Risk \u2013 Class B<\/strong><\/li><li><strong>Moderate-High\nRisk \u2013 Class C<\/strong><\/li><li><strong>High\nRisk \u2013 Class D<\/strong><\/li><\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Categorisation\nof Medical Devices<\/h3>\n\n\n\n<p>The\nnotification also mandated <strong><a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/cdsco-registration\">CDSCO Registration<\/a><\/strong> for Interventional and\nRadiology Medical Devices and other medical devices also. The devices notified\nin the list are mentioned below:<\/p>\n\n\n\n<table class=\"wp-block-table table table-bordered\"><tbody><tr><td>\n  <strong>Sr. No.<\/strong>\n  <\/td><td>\n  <strong>Medical device Name<\/strong>\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\n  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\n  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\n  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 (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  <strong>Interventional\n  and Radiology<\/strong>\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><strong><\/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>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_of_Medical_Devices_Pertaining_to_Interventional_and_Radiology\"><\/span>Classification\nof Medical Devices Pertaining to Interventional and Radiology<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nis the classification of Medical Devices pertaining to Interventional and\nRadiology:<\/p>\n\n\n\n<table class=\"wp-block-table table table-bordered\"><tbody><tr><td>\n  <strong>Name\n  of the Medical Device<\/strong>\n  <\/td><td>\n  <strong>Risk\n  Class<\/strong>\n  <\/td><\/tr><tr><td>\n  Scintillation (gamma) camera\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Positron camera\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Nuclear whole-body counter\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Bone densitometer\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Bone sonometer\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Emission computed tomography system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Fluorescent scanner\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Nuclear rectilinear scanner\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Nuclear Tomography System\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Nuclear uptake probe\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Nuclear Whole Body Scanner\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Nuclear Scanning Bed\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Radionuclide Dose Calibrator\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Radionuclide Rebreathing System\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Nuclear Sealed&nbsp; Calibration Source\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Nuclear Electrocardiograph\n  Synchronizer\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Non-Fatal Ultrasonic Monitor\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Ultrasonic Pulsed Doppler\n  Imaging System\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Ultrasonic Pulsed Echo Imaging\n  System\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Diagnostic Ultrasonic\n  Transducer\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Angiographic X-Ray System\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Diagnostic X-Ray Beam-Limiting\n  Device\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Cine or Spot Fluorography X-Ray\n  Camera\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Electrostatic X-Ray Imagining System\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Radiographic Film Marking\n  System\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Image-Intensified Fluoroscopic\n  X-Ray System\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Non-Image Intensified\n  Fluoroscopic X-Ray System\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Spot-Film Device\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Diagnostic X-Ray High Voltage\n  Generator\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Mammographic X-Ray System\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Photofluorography X-Ray System \n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Diagnostic X-Ray Tube Housing\n  Assembly\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Diagnostic X-Ray Tube Mount\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Pneumoenceph Alographic Chair\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Radiologic Patient Cradle\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Radiographic Film\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Radiographic Film Cassette\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Radiographic Film or Cassette\n  Changer&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Wall-Mounted Radiographic\n  Cassette Holder\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Radiographic Fil Illuminator\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Automatic Radiographic Film\n  Processor\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Radiographic Grid\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Radiographic Head Holder \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Radiologic Quality Assurance\n  Instrument\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Radiographic Intensifying\n  Screen\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Radiographic ECG or Respirator\n  Synchroniser\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Radiologic Table\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Transilluminator for Breast\n  Evaluation\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  Medical Image Storage Device\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  Radiological Computer-Assisted\n  Diagnostic Software for Lesions Suspicious of Cancer\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Medical Image Analyser\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Radiological Computer-Aided\n  Triage &amp; Notification Software\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Full-body MRI system, permanent\n  magnet\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Full-body MRI system, resistive\n  magnet\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Full-body MRI system,\n  superconducting magnet\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Foetal cardiac monitor\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Foetal Doppler system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  Flexible ultrasound colonoscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Flexible ultrasound duodenoscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Flexible ultrasound gastro\n  duodenoscopy\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Flexible ultrasound laparoscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Flexible ultrasound bronchoscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Bladder ultrasound imaging transducer\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  Blood flowmeter catheter,\n  Doppler\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  General-purpose ultrasound\n  imaging system\n  <\/td><td>\n  B\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_for_CDSCO_Registration_for_Interventional_and_Radiology_Medical_Devices\"><\/span>Documents\nRequired for CDSCO Registration for Interventional and Radiology Medical\nDevices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nis the list of all the crucial documents required for CDSCO Registration for\nInterventional and Radiology Medical Devices:<\/p>\n\n\n\n<ol><li>Duly-filled application form;<\/li><li>ISO 13485 Certificate;<\/li><li>Full Quality Assurance\nCertificate;<\/li><li>CE Design Certificate;<\/li><li>Undertaking that all details\nprovided is authentic;<\/li><li>Either an FSC (Free Sale\nCertificate)\/Certificate from the Foreign Government;<\/li><li>Plant Master Report;<\/li><li>Device Master File;<\/li><li>Declaration of Conformity.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_CDSCO_Registration_for_Interventional_and_Radiology_Medical_Devices\"><\/span>Procedure for\nCDSCO Registration for Interventional and Radiology Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following\nis the step-by-step online procedure for CDSCO Registration for Interventional\nand Radiology Medical Devices:<\/p>\n\n\n\n<p><strong>Step 1: Identifying whether your Medical Devices are under Notified List\/Not<\/strong>: The CDSCO has provided a list of notified medical devices that need to mandatorily get Registration under the <strong><em>Drugs &amp; Cosmetics Act, 1940<sup><a class=\"text-primary\" href=\"https:\/\/cdsco.gov.in\/opencms\/export\/sites\/CDSCO_WEB\/Pdf-documents\/acts_rules\/2016DrugsandCosmeticsAct1940Rules1945.pdf\"><strong>[1]<\/strong><\/a><\/sup> &amp; as per the Medical Device Rules, 2017<\/em><\/strong>. However, there may be any medical devices\/equipment that have not been notified by the CDSCO, or in the case of new Medical devices, the importer\/Manufacturer shall be required to get a NOC in such instances.<\/p>\n\n\n\n<p><strong>Step 2: Appoint an Authorised\nRepresentative (In case of Foreign Entity)<\/strong>: For a\nForeign Entity, it shall be vital to appoint an Authorised business entity in\nIndia, who shall be the contact person or individual for the inspection\nauthorities during the process, help in device approvals &amp; Registration\nProcess, &amp; vigilance adverse event reporting.<\/p>\n\n\n\n<p><strong>Step 3: Filing the Application\nForm<\/strong>: In this Registration step, the Manufacturer or\nImporter of Medical Device shall be required to submit the Registration Form of\na Regulatory dossier, along with all the requisited fee on the CDSCO portal, to\nthe DGCI.<\/p>\n\n\n\n<p><strong>Step 4: Obtain Registration\nCertificate<\/strong>: Once the application is submitted to the\nCDSCO, the authority may send a query or raise a query through an inquiry\nletter to the Manufacturer\/from the Authorised Representative of the Importer\nalong with the prescribed timeline within which the query should be answered\n&amp; sometimes, may also ask for a technical presentation. On satisfactory,\nthe concerned authority may issue a License.<\/p>\n\n\n\n<p><strong><em>Note:\nThe Certificate for CDSCO Registration for Interventional and Radiology Medical\nDevices is valid for 3 years from the issuance of Registration unless cancelled\nor suspended by the DCGI authority for proper causes.<\/em><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Post-Compliance_after_Getting_CDSCO_Registration_for_Interventional_and_Radiology_Medical_Devices\"><\/span>Post-Compliance\nafter Getting CDSCO Registration for Interventional and Radiology Medical\nDevices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ol><li>In case of any alteration that\nhas taken place concerning the constitution of the Firm and\/or address of the\nregistered office\/factory premises, the Medical Devices Manufacturer\/Authorised\nRepresentative of the Importer to intimate the Licensing Authority regarding\nthe same in writing.<\/li><li>In case of any such alterations\nhave taken place, the existing registration certificate shall be valid for 3\nmonths from the date on which the change or alteration has taken place, and\nduring this time, the Authorised Representative or Manufacturer shall be needed\nto obtain a new Registration Certificate.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In India, the Medical Device industry is increasing at a rapid scale; therefore it is vital to obtain a Certificate for CDSCO Registration for Interventional and Radiology Medical Devicesto ensure the quality &amp; safety of the device to the consumers on whom these medical devices are being used. However, the Medical Device Registration process might get technical in terms of rules &amp; procedures.<\/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>In India, medical experts use interventional radiology techniques to diagnose &amp; treat diseases. Medical experts can treat so many medical conditions through interventional radiology. In this medical technique, medical experts insert some same tools into the body, such as catheters or wire for different machines such as CT Scan, X-ray, and Ultrasound Machines. This interventional [&hellip;]<\/p>\n","protected":false},"author":35,"featured_media":50675,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2861],"acf":{"service_id":"508"},"authorName":"Karan Singh","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/processed-1-150x150.jpeg","authorDescription":"A legal writing enthusiast, a wanderer, and a zealous reader. After gaining a lot of knowledge about the diverse legal topics and developing research skills, Karan joined the league of legal content writers to deliver quality-rich blogs.","postViews":2920,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50674"}],"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\/35"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=50674"}],"version-history":[{"count":6,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50674\/revisions"}],"predecessor-version":[{"id":54810,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50674\/revisions\/54810"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/50675"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=50674"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=50674"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=50674"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}