{"id":50196,"date":"2022-10-19T14:20:23","date_gmt":"2022-10-19T08:50:23","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=50196"},"modified":"2025-01-17T18:34:32","modified_gmt":"2025-01-17T13:04:32","slug":"cdsco-registration-for-general-hospital-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-general-hospital-medical-devices\/","title":{"rendered":"CDSCO Registration for General Hospital Medical Devices &#8211; An Overview"},"content":{"rendered":"\n<p>The Drugs Controller General of India, or DCGI, issued a notification on 16th March 2022, which notified about the classification of medical devices pertaining to <strong><a href=\"https:\/\/corpbiz.io\/cdsco-registration\">CDSCO Registration<\/a><\/strong> for General Hospital Medical Devices under the provisions of Medical Device Rules, 2017. The notification includes 146 Medical Devices based on their Intended Use and Risk Classification. <\/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-general-hospital-medical-devices\/#Overview_of_CDCSO_Medical_Device_Rules_2017\" >Overview of CDCSO Medical\nDevice Rules, 2017<\/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-general-hospital-medical-devices\/#Medical_Device_Classification_in_India\" >Medical Device\nClassification in India<\/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-general-hospital-medical-devices\/#Classification_of_General_Hospital_Medical_Devices\" >Classification of\nGeneral Hospital Medical Devices&nbsp;<\/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-general-hospital-medical-devices\/#Documents_required_for_CDSCO_Registration_for_General_Hospital_Medical_Devices\" >Documents required for CDSCO Registration for General Hospital\nMedical 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-general-hospital-medical-devices\/#Procedure_for_CDSCO_Registration_for_General_Hospital_Medical_Devices\" >Procedure for CDSCO Registration for General Hospital 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-general-hospital-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Overview_of_CDCSO_Medical_Device_Rules_2017\"><\/span><strong>Overview of CDCSO Medical\nDevice Rules, 2017<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The Central Drug Standard Control\nOrganization (CDCSO) Introduced the Medical Device Rules, 2017, which became\neffective on 1<sup>st<\/sup> January 2018. The Rules were introduced to\ndifferentiate between Medical Devices and pharmaceuticals for registration. <\/p>\n\n\n\n<p>According to\nsection 2(zb) of Medical Device Rules 2017, the meaning of Medical Devices can\nbe interpreted as <em>specific substances or devices\nmeant for external or internal use to diagnose, treat, prevent or mitigate any kind\nof disorder or disease in humans or animals. <\/em><\/p>\n\n\n\n<p><em>Medical devices can also be defined as specific\nsubstances which are notified by the government and are meant to affect any\nkind of structure or function of the human body. It also includes substances\nused for in vitro diagnosis. Devices used as surgical dressings, staples, bandages,\nsutures, ligatures, and Blood and blood components, whether with or without\nanticoagulants, can also be called medical devices.<\/em><\/p>\n\n\n\n<p>CDSCO has done a classification of Medical\nDevices based on the risk involved with the devices. The category has been made\nas follows- <\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  Medical device\n  <\/td><td>\n  Risk level \n  <\/td><\/tr><tr><td>\n  Class-A Medical devices\n  <\/td><td>\n  Low risk\n  <\/td><\/tr><tr><td>\n  Class-B Medical devices\n  <\/td><td>\n  Low-Medium risk\n  <\/td><\/tr><tr><td>\n  Class-C Medical devices\n  <\/td><td>\n  Medium-High risk\n  <\/td><\/tr><tr><td>\n  Class-D Medical devices\n  <\/td><td>\n  High risk\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Medical_Device_Classification_in_India\"><\/span><strong>Medical Device\nClassification in India<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Based on\nregistration, the Medical Devices have been classified into two types- <\/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>Earlier, only 37\nMedical devices were regulated in India. Gradually, with the increased\nawareness of health and related issues, the demand for medical devices\nincreased among Indian Customers, and health-related matters were also exposed.\nSlowly, more devices were put into the ambit of Notified Medical devices to\nensure the safety of the Customers. <\/p>\n\n\n\n<p>Ministry of\nHealth and Family Welfare issued a notification on 11th Feb 2020, which invited\nthe Voluntary registration of Non-Notified medical devices before the given\ndeadline. The deadline has been classified according to the risk classification\nof medical devices, which are as follows- <\/p>\n\n\n\n<ul>\n<li>For Class A and B Medical\nDevices, the deadline is till 1<sup>st<\/sup> October 2022<\/li>\n\n\n\n<li>For Class C and D Medical\nDevices, the deadline is 1<sup>st<\/sup> October 2023<\/li>\n<\/ul>\n\n\n\n<p>After the\ndeadline, all non-notified medical devices will be included in the category of\nmandatory registration along with the notified medical devices. <\/p>\n\n\n\n<p>CDSCO also notified 24 new <strong><a href=\"https:\/\/corpbiz.io\/medical-device-registration\">medical devices for registration<\/a><\/strong>, in a notification dated 3rd September 2020. The list also included CDSCO Registration for General Hospital Medical Devices. The details of the devices are listed in the table below &#8211; <\/p>\n\n\n\n<table class=\"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  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  <strong>8<\/strong>\n  <\/td><td>\n  <strong>General Hospital&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <\/strong>\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=\"Classification_of_General_Hospital_Medical_Devices\"><\/span><strong>Classification of\nGeneral Hospital Medical Devices&nbsp; <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On 16<sup>th<\/sup>\nMarch 2022, The DCGI issued a notification related to CDSCO Registration for\nGeneral Hospital Medical Devices, titled- \u201c<strong><em>Classification of Medical Devices Pertaining\nto General Hospital\/Orthopaedic Instruments<\/em><\/strong>\u201d, governed by the <strong>Medical Device\nRules, 2017<\/strong><sup><a class=\"text-primary\" href=\"https:\/\/pib.gov.in\/newsite\/printrelease.aspx?relid=157955\"><strong>[1]<\/strong><\/a><\/sup>.<\/p>\n\n\n\n<p>The notification\nlisted 146 Medical devices for registration based on Intended Use and Risk\nClassification. The list of devices is as follows- <\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Sr.No. <\/strong>\n  <\/td><td>\n  <strong>Device Name <\/strong>\n  <\/td><td>\n  <strong>Risk Class<\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>1<\/strong>\n  <\/td><td>\n  Liquid\n  crystal forehead temperature strip\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>2 <\/strong>\n  <\/td><td>\n  Bed exit monitor, Fall prevention \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>3 <\/strong>\n  <\/td><td>\n  Electronic\n  monitor for gravity flow infusion systems\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>4 <\/strong>\n  <\/td><td>\n  Electrically powered spinal fluid pressure\n  monitor\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>5 <\/strong>\n  <\/td><td>\n  Spinal fluid\n  manometer \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>6 <\/strong>\n  <\/td><td>\n  Stand-on patient scale \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>7 <\/strong>\n  <\/td><td>\n  Patient scale\n  \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>8 <\/strong>\n  <\/td><td>\n  Sterilization process indicator(Biological)\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>9 <\/strong>\n  <\/td><td>\n  Sterilization\n  process indicator (Physical\/chemical)\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>10 <\/strong>\n  <\/td><td>\n  Clinical colour change thermometer\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>11 <\/strong>\n  <\/td><td>\n  Apgar timer. \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>12 <\/strong>\n  <\/td><td>\n  Hydraulic adjustable hospital bed. \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>13 <\/strong>\n  <\/td><td>\n  Manual\n  adjustable hospital bed.\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>14 <\/strong>\n  <\/td><td>\n  Pediatric medical crib. \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>15 <\/strong>\n  <\/td><td>\n  Medical\n  bassinet.\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>16 <\/strong>\n  <\/td><td>\n  Nonpowered flotation therapy mattress.\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>17<\/strong>\n  <\/td><td>\n  Therapeutic\n  medical binder.\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>18 <\/strong>\n  <\/td><td>\n  Burn sheet. \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>19 <\/strong>\n  <\/td><td>\n  Neonatal eye\n  pad. \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>20 <\/strong>\n  <\/td><td>\n  Pressure infusor for an I.V. bag. \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>21 <\/strong>\n  <\/td><td>\n  Intravascular\n  administration set, automated air removal system.\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>22 <\/strong>\n  <\/td><td>\n  Patient care reverse isolation chamber.\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>23 <\/strong>\n  <\/td><td>\n  Jet lavage.\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>24 <\/strong>\n  <\/td><td>\n  Patient lift, Electrcially powered \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>25 <\/strong>\n  <\/td><td>\n  Nipple\n  shield.\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>26 <\/strong>\n  <\/td><td>\n  Lamb feeding nipple. \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>27 <\/strong>\n  <\/td><td>\n  Suction\n  snakebite kit. \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>28 <\/strong>\n  <\/td><td>\n  Chemical cold pack snakebite kit\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  <strong>29 <\/strong>\n  <\/td><td>\n  Therapeutic\n  scrotal support. \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>30 <\/strong>\n  <\/td><td>\n  Cardiopulmonary resuscitation board.\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>31 <\/strong>\n  <\/td><td>\n  Ultrasonic\n  cleaner for medical instruments.\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>32<\/strong>\n  <\/td><td>\n  Medical insole. \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>33 <\/strong>\n  <\/td><td>\n  Ingestible\n  event marker\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>34 <\/strong>\n  <\/td><td>\n  Remote Medication Management System\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>35 <\/strong>\n  <\/td><td>\n  Medical\n  examination light, A.C. powered or Battery\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>36 <\/strong>\n  <\/td><td>\n  Skin pressure protectors\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>37 <\/strong>\n  <\/td><td>\n  Ultraviolet\n  (U.V.) radiation environmental disinfection device\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>38<\/strong>\n  <\/td><td>\n  Ultraviolet (U.V.) radiation chamber disinfection\n  device.\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>39<\/strong>\n  <\/td><td>\n  Body waste\n  receptacle\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>40 <\/strong>\n  <\/td><td>\n  Vacuum-powered body fluid suction apparatus.\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>41<\/strong>\n  <\/td><td>\n  Washers for\n  body waste receptacles.\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>42 <\/strong>\n  <\/td><td>\n  Sterilization wrap\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>43 <\/strong>\n  <\/td><td>\n  Ethylene\n  oxide gas sterilizer. \n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>44 <\/strong>\n  <\/td><td>\n  Dry-heat sterilizer. \n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>45 <\/strong>\n  <\/td><td>\n  Steam\n  sterilizer\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>46<\/strong>\n  <\/td><td>\n  Liquid chemical sterilants\/high-level\n  disinfectants.\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>47 <\/strong>\n  <\/td><td>\n  Hand-carried\n  stretcher. \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>48 <\/strong>\n  <\/td><td>\n  Manual Wheeled stretcher. \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>49<\/strong>\n  <\/td><td>\n  Motorised\n  Wheeled stretcher\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>50 <\/strong>\n  <\/td><td>\n  Liquid crystal vein locator. \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>51 <\/strong>\n  <\/td><td>\n  Medical\n  washer\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>52 <\/strong>\n  <\/td><td>\n  Medical washer-disinfector\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>53 <\/strong>\n  <\/td><td>\n  Hydrogen\n  Peroxide Gas Plasma Sterilization System\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  <strong>54 <\/strong>\n  <\/td><td>\n  Blood bank centrifuge \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>55 <\/strong>\n  <\/td><td>\n  Environmental\n  chamber for storage of platelet concentrate\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>56<\/strong>\n  <\/td><td>\n  Blood storage refrigerator \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>57<\/strong>\n  <\/td><td>\n  Heat-sealing\n  device \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>58<\/strong>\n  <\/td><td>\n  Templates \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>59 <\/strong>\n  <\/td><td>\n  X- ray marker\n  for strut\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>60 <\/strong>\n  <\/td><td>\n  Clamp \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>61 <\/strong>\n  <\/td><td>\n  Container for\n  orthopaedic cement dispensor\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>62 <\/strong>\n  <\/td><td>\n  Box Wrench for Nut\/Bolt \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>63 <\/strong>\n  <\/td><td>\n  The\n  instrument set for an external fixation system\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>64<\/strong>\n  <\/td><td>\n  Spinal cage system instruments \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>65 <\/strong>\n  <\/td><td>\n  Cervical\n  plate system instruments \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>66 <\/strong>\n  <\/td><td>\n  Mesh system instruments \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>67 <\/strong>\n  <\/td><td>\n  Cervical disc\n  spacer instruments for the Spine\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>68 <\/strong>\n  <\/td><td>\n  Spinal Instrument \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>69&nbsp; <\/strong>\n  <\/td><td>\n  Instrument\n  set for Bone Screws &amp; Plates\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>70 <\/strong>\n  <\/td><td>\n  Electronic Drive Instruments &amp; Accessories\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>71 <\/strong>\n  <\/td><td>\n  Instrument\n  system for bipolar hip system\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>72 <\/strong>\n  <\/td><td>\n  Plaster Instruments\/Saw \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>73 <\/strong>\n  <\/td><td>\n  Wire\n  tensioner \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>74 <\/strong>\n  <\/td><td>\n  Thick \/Thin Guide Pin \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>75 <\/strong>\n  <\/td><td>\n  Depth Gauge \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>77 <\/strong>\n  <\/td><td>\n  Bone Tap \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>78 <\/strong>\n  <\/td><td>\n  Reamer &amp;\n  its attachment \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>79 <\/strong>\n  <\/td><td>\n  Torque Wrench\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>80 <\/strong>\n  <\/td><td>\n  Pedical Screw\n  Instruments \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>81 <\/strong>\n  <\/td><td>\n  Surgical Probe \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>82 <\/strong>\n  <\/td><td>\n  Rod\n  Cutter\/Reducer \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>83 <\/strong>\n  <\/td><td>\n  Alignment Guide \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>84 <\/strong>\n  <\/td><td>\n  Retractor\n  Holder \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>85 <\/strong>\n  <\/td><td>\n  Extractor \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>86 <\/strong>\n  <\/td><td>\n  Retractor \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>87 <\/strong>\n  <\/td><td>\n  Bone Curette \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>88 <\/strong>\n  <\/td><td>\n  Bone Cutter \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>89 <\/strong>\n  <\/td><td>\n  Surgical Punch\/Bone Punch \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>90 <\/strong>\n  <\/td><td>\n  Surgical \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>91 <\/strong>\n  <\/td><td>\n  Hook\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>92<\/strong>\n  <\/td><td>\n  Dissector \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>93 <\/strong>\n  <\/td><td>\n  Surgical Spatula \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>94<\/strong>\n  <\/td><td>\n  Osteotome \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>95 <\/strong>\n  <\/td><td>\n  Surgical Elevator \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>96 <\/strong>\n  <\/td><td>\n  Needle Holder\n  \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>97 <\/strong>\n  <\/td><td>\n  Scissor\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>98 <\/strong>\n  <\/td><td>\n  Approximator \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>99 <\/strong>\n  <\/td><td>\n  Pliers \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>100<\/strong>\n  <\/td><td>\n  Tamp,\n  Surgical \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>101 <\/strong>\n  <\/td><td>\n  Orthopaedic Countersink \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>102 <\/strong>\n  <\/td><td>\n  Wrench \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>103 <\/strong>\n  <\/td><td>\n  Periostic elevator\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>104<\/strong>\n  <\/td><td>\n  Pneumatic\n  Tourniquet &amp; its attachment\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>105 <\/strong>\n  <\/td><td>\n  Electronically operated Tourniquet Single &amp;\n  Double Cuff Consol\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>106 <\/strong>\n  <\/td><td>\n  Forceps \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>107 <\/strong>\n  <\/td><td>\n  Plaster Knife \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>109 <\/strong>\n  <\/td><td>\n  Surgical\n  Drill &amp; its attachment \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>110 <\/strong>\n  <\/td><td>\n  Surgical Trays \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>111 <\/strong>\n  <\/td><td>\n  Implant\n  Trials \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>112 <\/strong>\n  <\/td><td>\n  Computer-Assisted Surgery System\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>113 <\/strong>\n  <\/td><td>\n  Knee System\n  Instruments \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>114 <\/strong>\n  <\/td><td>\n  Hip System Instrument \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>115<\/strong>\n  <\/td><td>\n  Insertion and\n  removal instruments \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>116 <\/strong>\n  <\/td><td>\n  Bone cement accessories \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>117 <\/strong>\n  <\/td><td>\n  Sleeves and\n  their attachment \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>118 <\/strong>\n  <\/td><td>\n  Arthroscopes\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>119 <\/strong>\n  <\/td><td>\n  Arthroscopic\n  Instruments \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>120 <\/strong>\n  <\/td><td>\n  Shaver System \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  <strong>121<\/strong>\n  <\/td><td>\n  A\n  visualization system for the arthroscopic and endoscopic procedure\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>122 <\/strong>\n  <\/td><td>\n  Fluid Management System \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>123 <\/strong>\n  <\/td><td>\n  Bone Chisel \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>124 <\/strong>\n  <\/td><td>\n  Pusher \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>125 <\/strong>\n  <\/td><td>\n  Bender \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>126 <\/strong>\n  <\/td><td>\n  Dilator &amp; accessories \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>127 <\/strong>\n  <\/td><td>\n  Surgical\n  Screw Driver \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>128 <\/strong>\n  <\/td><td>\n  Orthopaedic implant impactor \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>129 <\/strong>\n  <\/td><td>\n  Rail Fixation\n  System \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>130 <\/strong>\n  <\/td><td>\n  The external Ring fixation system \n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>131 <\/strong>\n  <\/td><td>\n  Six-axis\n  correction apparatus with software\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>132 <\/strong>\n  <\/td><td>\n  Unilateral External Fixation System\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>133<\/strong>\n  <\/td><td>\n  Intramedullary\n  Locking Nail Instrument Sets\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  <strong>134 <\/strong>\n  <\/td><td>\n  Adhesive Plaster B.P.\u2019 88 (Zinc Oxide Adhesive\n  Plaster)\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>135 <\/strong>\n  <\/td><td>\n  Adhesive Tape\n  USP \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>136 <\/strong>\n  <\/td><td>\n  Elasticated Cohesive Bandage \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>137 <\/strong>\n  <\/td><td>\n  Cotton and\n  Rubber Elastic Bandage\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>138 <\/strong>\n  <\/td><td>\n  Cotton Crepe Bandage \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>139 <\/strong>\n  <\/td><td>\n  Elastic\n  Adhesive Bandage \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>140 <\/strong>\n  <\/td><td>\n  Extension Plaster \u2013width-wise stretchable\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>141<\/strong>\n  <\/td><td>\n  Microporous\n  surgical tape \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>142 <\/strong>\n  <\/td><td>\n  Orthopaedic cast padding \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>143 <\/strong>\n  <\/td><td>\n  Plaster of\n  Paris Bandage \n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>145 <\/strong>\n  <\/td><td>\n  Skin traction kit\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  <strong>146 <\/strong>\n  <\/td><td>\n  Tearable\n  Adhesive Tape \n  <\/td><td>\n  A\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_General_Hospital_Medical_Devices\"><\/span><strong>Documents required for CDSCO Registration for General Hospital\nMedical Devices<\/strong> <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following is a checklist for CDSCO\nRegistration for General Hospital Medical Devices:<\/p>\n\n\n\n<ul>\n<li>Application form<\/li>\n\n\n\n<li>Power of Attorney<\/li>\n\n\n\n<li>Certificate of quality\nassurance<\/li>\n\n\n\n<li>C.E. Design accreditation<\/li>\n\n\n\n<li>Challan TR6<\/li>\n\n\n\n<li>Plant-Master File<\/li>\n\n\n\n<li>ISO 13485 certificate<\/li>\n\n\n\n<li>Declaration of conformity<\/li>\n\n\n\n<li>Schedule D(I)<\/li>\n\n\n\n<li>An Undertaking declaring that\nthe information stated is correct<\/li>\n\n\n\n<li>Device-master file <\/li>\n\n\n\n<li>Free sale certificate<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_CDSCO_Registration_for_General_Hospital_Medical_Devices\"><\/span><strong>Procedure for CDSCO Registration for General Hospital Medical\nDevices <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>CDSCO Registration for General Hospital\nMedical Devices can be applied by following procedure- <\/p>\n\n\n\n<ol>\n<li>The applicant must first\nIdentify the Medical device category and its risk based classification<\/li>\n\n\n\n<li>If the manufacturer is not an\nIndian, then an Indian Authorized Agent is appointed on his behalf to carry out\nhis official functions and duties in India.The IAA is also liable to represent\nthe manufacturer in&nbsp; court.<\/li>\n\n\n\n<li>All the required documents and\nforms must be submitted to the relevant licensing authority to obtain the\nregistration certificate.<\/li>\n\n\n\n<li>After verifying the submitted\ndocuments and reports, if the licensing authority is satisfied, then the CDSCO\nRegistration for General Hospital Medical Devices is granted to the\nmanufacturer. <\/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>The government has listed the CDSCO Registration for General Hospital Medical Devices for registration as medical devices. A notice was issued on 3<sup>rd<\/sup> September 2020, which listed 24 new machines to be included in the list of medical devices. The medical devices must be registered before being manufactured, imported, sold or marketed in India. However, the registration process can be technical, and a slight mistake might lead to considerable challenges in terms of funds and time. It is always better to connect with experienced professionals for CDSCO Registration for General Hospital Medical Devices to save time and money wasted on any failure. <\/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-rheumatology-medical-devices\/\">CDSCO Registration for Rheumatology Medical Devices<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Drugs Controller General of India, or DCGI, issued a notification on 16th March 2022, which notified about the classification of medical devices pertaining to CDSCO Registration for General Hospital Medical Devices under the provisions of Medical Device Rules, 2017. The notification includes 146 Medical Devices based on their Intended Use and Risk Classification. Overview [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":50199,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2794],"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":4019,"readingTime":6,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50196"}],"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=50196"}],"version-history":[{"count":5,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50196\/revisions"}],"predecessor-version":[{"id":68371,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/50196\/revisions\/68371"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/50199"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=50196"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=50196"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=50196"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}