{"id":50244,"date":"2022-10-22T11:09:46","date_gmt":"2022-10-22T05:39:46","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=50244"},"modified":"2022-10-21T14:13:11","modified_gmt":"2022-10-21T08:43:11","slug":"cdsco-registration-for-urology-medical-device-a-complete-analysis","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-urology-medical-device-a-complete-analysis\/","title":{"rendered":"CDSCO Registration for Urology Medical Device &#8211; A Complete Analysis"},"content":{"rendered":"\n<p>Before 2006, the Medical Device Industry was utterly unregulated in India. Customers were exposed to various health and life threats caused by unregulated, cheap-quality medical devices. With the increase in the medical device industry, the risks increased. Due to customers&#8217; exposure to unregulated medical devices, CDSCO mandated the registration of medical devices before being manufactured, imported or Sold in India. With this rule, it became mandatory to get registration certificates for notified medical devices. On 3<sup>rd<\/sup> September 2020, CDSCO issued a notification that listed 24 <a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>Medical devices for registration<\/strong><\/a>. CDSCO Registration for Urology Medical Devices has also been included in the list. <\/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-urology-medical-device-a-complete-analysis\/#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-urology-medical-device-a-complete-analysis\/#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-urology-medical-device-a-complete-analysis\/#CSDCO_Regulation_on_Urology_Medical_Devices\" >CSDCO Regulation on\nUrology 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-urology-medical-device-a-complete-analysis\/#i\" >&nbsp;<\/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-urology-medical-device-a-complete-analysis\/#Documents_required_for_CDSCO_Registration_for_Urology_Medical_Device\" >Documents required for CDSCO Registration\nfor Urology Medical Device<\/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-urology-medical-device-a-complete-analysis\/#Procedure_for_CDSCO_Registration_for_Urology_Medical_Device\" >Procedure for CDSCO Registration for Urology\nMedical Device<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-urology-medical-device-a-complete-analysis\/#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>The Central Drug\nStandard Control Organization has broadly classified two categories of Medical\nDevices based on their registration-<\/p>\n\n\n\n<ul><li>Non-Notified Medical Devices <\/li><li>Notified Medical Devices <\/li><\/ul>\n\n\n\n<p>Until the recent\nnotification issued by CDSCO, only 37 notified medical devices were registered\nin India. Notification 648 (E), published by the Directorate General of Health\nand Services, listed the following medical devices to be considered drugs from\n1<sup>st<\/sup> April 2020. &nbsp;<\/p>\n\n\n\n<p><em>All the devices that are used as appliances,\nInstruments, materials, apparatus, implants or any other tool, which is used either\nseparately or along with any another device, accessory or software for use in\nhuman beings or animals, and do not achieve the primary intended action in or\non animal or human body by any pharmacological, Immunological or metabolic way,\nbut it may help in its intended function or for one or more specific purpose\nof-<\/em><\/p>\n\n\n\n<ol><li><em>Diagnosis, monitoring, preventing and alleviating any injury or\ndisability.<\/em><\/li><li><em>Diagnosis, monitoring, controlling, alleviating or treating any kind\nof disorder or disease <\/em><\/li><li><em>Life support and sustaining <\/em><\/li><li><em>Replacing, investigating, supporting or modifying a physiological\nprocess or the anatomy<\/em><\/li><li><em>Conception control<\/em><\/li><li><em>Medical Device disinfection<\/em><\/li><\/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 a\nnotice on 3<sup>rd<\/sup> September 2020, which notified 24 medical devices to\nbe listed in the category of mandatory CDSCO registration. The list included CDSCO\nRegistration for Urology Medical Devices and 23 other medical devices. The list\nissued in a notification is mentioned as follows- <\/p>\n\n\n\n<table class=\"wp-block-table table table-bordered\"><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  <strong>7<\/strong>\n  <\/td><td>\n  <strong>Urological&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/strong>\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\n  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  22\n  <\/td><td>\n  Radiotherapy&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \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=\"CSDCO_Regulation_on_Urology_Medical_Devices\"><\/span><strong>CSDCO Regulation on\nUrology Medical Devices <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Drug\nController General of India notified on 23<sup>rd<\/sup> August 2021, notifying\nabout the Classification of Medical Devices pertaining to Urology under the\nMedical Device Rules, 2017. The Classification listed 88 medical devices for\nCDSCO Registration for Urology Medical Device, based on the risk classification\nand Intended use. The list of medical devices is mentioned below- <\/p>\n\n\n\n<table class=\"wp-block-table table table-bordered\"><tbody><tr><td>\n  <strong>Sr.No.\n  <\/strong>\n  <\/td><td>\n  <strong>Device Name &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/strong>\n  <\/td><td>\n  <strong>Risk\n  Class<\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>1<\/strong>\n  <\/td><td>\n  Bare-metal\n  urethral stent, short-term\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>2<\/strong>\n  <\/td><td>\n  Biliary\/urinary\n  stone retrieval basket\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>3<\/strong>\n  <\/td><td>\n  Bladder\n  neck spreader \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>4<\/strong>\n  <\/td><td>\n  Bladder-emptying\n  vibratory stimulator\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>5<\/strong>\n  <\/td><td>\n  Closed-ended\n  wearable urine collection bag, nonsterile\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>6<\/strong>\n  <\/td><td>\n  Closed-ended\n  wearable urine collection bag, sterile\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>7<\/strong>\n  <\/td><td>\n  Cystometer\n  \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>8<\/strong>\n  <\/td><td>\n  Cystometer\n  probe, ultrasonic\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>9<\/strong>\n  <\/td><td>\n  Cystoscopic\n  electrode \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>10<\/strong>\n  <\/td><td>\n  Diaphragm\n  wearable urinal \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>11<\/strong>\n  <\/td><td>\n  Draping\n  incontinence liner \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>12<\/strong>\n  <\/td><td>\n  Drip\n  wearable urinal \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>13<\/strong>\n  <\/td><td>\n  Electrohydraulic\n  lithotripsy system\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>14<\/strong>\n  <\/td><td>\n  Electrohydraulic\/pneumatic\n  lithotripsy system probe, urinary, single-use\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>15<\/strong>\n  <\/td><td>\n  Electromechanical\n  lithotripsy system, extracorporeal\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>16<\/strong>\n  <\/td><td>\n  Electromechanical\n  lithotripsy system, intracorporeal\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>17<\/strong>\n  <\/td><td>\n  Female\n  wearable urinal, reusable\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>18<\/strong>\n  <\/td><td>\n  Fibreoptic\n  ureteral catheter, reusable\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>19<\/strong>\n  <\/td><td>\n  Filiform\n  urethral bougie \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>20<\/strong>\n  <\/td><td>\n  Flexible\n  endoscopic stoneretrieval forceps, reusable\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>21<\/strong>\n  <\/td><td>\n  Flexible\n  fibreoptic cystonephroscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>22<\/strong>\n  <\/td><td>\n  Flexible\n  fibreoptic cystoscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>23<\/strong>\n  <\/td><td>\n  Flexible\n  fibreoptic cystourethroscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>24<\/strong>\n  <\/td><td>\n  Flexible\n  fibreoptic nephroscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>25<\/strong>\n  <\/td><td>\n  Flexible\n  fibreoptic ureterorenoscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>26<\/strong>\n  <\/td><td>\n  Flexible\n  fibreoptic ureteroscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>27<\/strong>\n  <\/td><td>\n  Flexible\n  fibreoptic urethroscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>28<\/strong>\n  <\/td><td>\n  Flexible\n  ureteral sheath\/fibreoptic telescope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>29<\/strong>\n  <\/td><td>\n  Flexible\n  video cystonephroscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>30<\/strong>\n  <\/td><td>\n  Flexible\n  video cystoscope, reusable\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>31<\/strong>\n  <\/td><td>\n  Flexible\n  video cystourethroscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>32<\/strong>\n  <\/td><td>\n  Flexible\n  video nephroscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>33<\/strong>\n  <\/td><td>\n  Flexible\n  video ureterorenoscope, reusable\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>34<\/strong>\n  <\/td><td>\n  Flexible\n  video ureteroscope, reusable\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>35<\/strong>\n  <\/td><td>\n  Flexible\n  video urethroscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>36<\/strong>\n  <\/td><td>\n  General-purpose\n  ureteral catheter\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>37<\/strong>\n  <\/td><td>\n  Hand\n  pneumatic lithotripsy system, urinary\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>38<\/strong>\n  <\/td><td>\n  Hand-held\n  urinal, female \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>39<\/strong>\n  <\/td><td>\n  Hand-held\n  urinal, male, reusable\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>40<\/strong>\n  <\/td><td>\n  Hepatic\n  function analysis system\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>41<\/strong>\n  <\/td><td>\n  Home\n  faecal specimen collection kit\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>42<\/strong>\n  <\/td><td>\n  Hydraulic\n  male urinary incontinence treatment system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>43<\/strong>\n  <\/td><td>\n  Hydraulic\n  male urinary incontinence treatment system port\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>44<\/strong>\n  <\/td><td>\n  Hydraulic\n  male urinary incontinence treatment system tubing\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>45<\/strong>\n  <\/td><td>\n  Hydraulic\n  male urinary incontinence treatment system tubing plug\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>46<\/strong>\n  <\/td><td>\n  Incontinence\n  device suspender\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>47<\/strong>\n  <\/td><td>\n  Incontinence\n  penis clamp, reusable\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>48<\/strong>\n  <\/td><td>\n  Incontinence\n  sensor\/alarm \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>49<\/strong>\n  <\/td><td>\n  Inflatable\n  penile prosthesis \n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>50<\/strong>\n  <\/td><td>\n  Intermittent\n  urethral catheterization kit, nonsterile\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>51<\/strong>\n  <\/td><td>\n  Intermittent\n  urethral catheterization kit, sterile\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>52<\/strong>\n  <\/td><td>\n  Intermittent\n  urethral drainage catheter, antimicrobial\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>53<\/strong>\n  <\/td><td>\n  Intermittent\n  urethral drainage catheter, nonsterile\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>54<\/strong>\n  <\/td><td>\n  Intermittent\n  urethral drainage catheter, sterile\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>55<\/strong>\n  <\/td><td>\n  Intracorporeal\n  lithotripsy suction system\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>56<\/strong>\n  <\/td><td>\n  Intraurethral\n  valve\/pump \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>57<\/strong>\n  <\/td><td>\n  Laser\n  lithotripsy fibre\/suction guide\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>58<\/strong>\n  <\/td><td>\n  Laser\n  lithotripsy system \n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>59<\/strong>\n  <\/td><td>\n  Lithotrite\n  \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>60<\/strong>\n  <\/td><td>\n  Male\n  urinary outflow analysis system\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>61\n  <\/strong>\n  <\/td><td>\n  Male\n  urinary outflow analysis system cuff\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>62<\/strong>\n  <\/td><td>\n  Manometric\n  catheter sheath\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>63<\/strong>\n  <\/td><td>\n  Microwave\n  hyperthermia system catheter, prostaticablation, reusable\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>64<\/strong>\n  <\/td><td>\n  Penile\n  extracorporeal shock wave therapy system\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>65<\/strong>\n  <\/td><td>\n  Penile\n  extracorporeal shock wave therapy system applicator\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>66<\/strong>\n  <\/td><td>\n  Penis\n  wearable urinal \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>67<\/strong>\n  <\/td><td>\n  Penis\/scrotum\n  wearable urinal\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>68<\/strong>\n  <\/td><td>\n  Perineal\n  orifice incontinence-control electrical stimulation system, remote control\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>69<\/strong>\n  <\/td><td>\n  Piezoelectric\n  lithotripsy system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>70<\/strong>\n  <\/td><td>\n  Pyeloscope\n  \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>71<\/strong>\n  <\/td><td>\n  Rigid\n  cystoscope \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>72<\/strong>\n  <\/td><td>\n  Rigid\n  cystourethroscope \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>73<\/strong>\n  <\/td><td>\n  Rigid\n  nephroscope \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>74<\/strong>\n  <\/td><td>\n  Rigid\n  ureterorenoscope \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>75<\/strong>\n  <\/td><td>\n  Rigid\n  ureteroscope \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>76<\/strong>\n  <\/td><td>\n  Rigid\n  urethroscope \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>77<\/strong>\n  <\/td><td>\n  Rigid\n  video ureterorenoscope\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>78<\/strong>\n  <\/td><td>\n  Spark-gap\n  lithotripsy system\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>79<\/strong>\n  <\/td><td>\n  Suprapubic\n  needle, surgical, reusable\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>80<\/strong>\n  <\/td><td>\n  Temperature-monitoring\n  indwelling urethral drainage catheter\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>81<\/strong>\n  <\/td><td>\n  Transobturator\n  needle, reusable\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>82<\/strong>\n  <\/td><td>\n  Transvaginal\n  needle, surgical\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>83<\/strong>\n  <\/td><td>\n  Ultrasonic\n  lithotripsy system\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>84<\/strong>\n  <\/td><td>\n  Ureteral\n  patency kit \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>85<\/strong>\n  <\/td><td>\n  Urethral\n  drainage catheter punch\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>86<\/strong>\n  <\/td><td>\n  Urethral\/suprapubic\n  catheter valve-connector\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>87<\/strong>\n  <\/td><td>\n  Urinary-incontinence\n  vaginal insert, reusable\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>88<\/strong>\n  <\/td><td>\n  Urodynamic\n  measurement 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=\"i\"><\/span><strong>&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_required_for_CDSCO_Registration_for_Urology_Medical_Device\"><\/span><strong>Documents required for <\/strong><strong>CDSCO Registration\nfor Urology Medical Device<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ol><li>Application Form<\/li><li>ISO 13485 Certificate <\/li><li>Declaration of conformity<\/li><li>Free sale certificate <\/li><li>Undertaking that only authentic\ndetails are provided <\/li><li>TR6 Challan<\/li><li>Device master file <\/li><li>Power of attorney<\/li><li>Full quality assurance\ncertificate <\/li><li>Plant master file <\/li><li>Schedule D(I) <\/li><li>C.E. Design certificate <\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_CDSCO_Registration_for_Urology_Medical_Device\"><\/span><strong>Procedure for <\/strong><strong>CDSCO Registration for Urology\nMedical Device<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>To obtain CDSCO Registration for Urology\nMedical Devices in India, the following steps are followed- <\/p>\n\n\n\n<ol><li>To get CDSCO registration, it\nmust be checked whether the medical device belongs to the notified or non-notified\nmedical device category, along with their risk classification. In the case of a\nnon-notified medical device, the manufacturer must obtain voluntary\nregistration before the given deadline based on its risk class. The CDSCO\nRegistration for Urology Medical Device falls under the ambit of notified\nmedical devices, as notified by CDSCO.<\/li><li>A foreign manufacturer cannot\nperform any of the official duties in India. Therefore an Indian Authorized\nAgent (IAA) is appointed on his behalf to carry out all the official duties on\nbehalf of the manufacturer as his representative.<\/li><li>The IAA or Manufacturer must\ncomplete all the necessary forms and submit all the required documents to the relevant\nLicencing authorities to obtain CDSCO Registration for Urology Medical Devices.<\/li><li>After verifying all the\ndocuments, the CDSCO License is granted to the applicant after the licensing\nauthority is satisfied. <\/li><\/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>Getting CDSCO Registration for <strong>Urology<\/strong><sup><a class=\"text-primary\" href=\"https:\/\/en.wikipedia.org\/wiki\/Urology\"><strong>[1]<\/strong><\/a><\/sup> Medical Devices before they are manufactured, sold or Imported in India is essential to ensure that the customers on whom these medical devices are being used are safe and free from health and life risks. The process of obtaining CDSCO registration for the medical device might be complicated in terms of procedure and rules. Therefore, professional and expert help must be taken to obtain CDSCO Registration for Urology Medical Devices to avoid losses. <\/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\/cdsco-registration-for-general-hospital-medical-devices\/\">CDSCO Registration for General Hospital Medical Devices \u2013 An Overview<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Before 2006, the Medical Device Industry was utterly unregulated in India. Customers were exposed to various health and life threats caused by unregulated, cheap-quality medical devices. With the increase in the medical device industry, the risks increased. Due to customers&#8217; exposure to unregulated medical devices, CDSCO mandated the registration of medical devices before being manufactured, [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":50247,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[946],"tags":[2801],"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":3112,"readingTime":5,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50244"}],"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=50244"}],"version-history":[{"count":3,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50244\/revisions"}],"predecessor-version":[{"id":50248,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50244\/revisions\/50248"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/50247"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=50244"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=50244"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=50244"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}