{"id":49997,"date":"2022-10-13T11:08:07","date_gmt":"2022-10-13T05:38:07","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=49997"},"modified":"2022-10-13T11:08:07","modified_gmt":"2022-10-13T05:38:07","slug":"cdsco-medical-device-registration-for-paediatrics-and-neonatology","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-paediatrics-and-neonatology\/","title":{"rendered":"CDSCO Medical Device Registration for Paediatrics and Neonatology"},"content":{"rendered":"\n<p>The Central Drug Standard Control Organization, or CDSCO, is the national regulatory authority of India, headed by the DCGI. The Medical Device Rules, 2017, were introduced to regulate the laws and rules related to the Manufacture, Import, Clinical Investigation, Distribution and Sale of Medical devices in India. On 23<sup>rd<\/sup> August 2021, the DCGI notified <a href=\"https:\/\/corpbiz.io\/medical-device-registration\"><strong>CDSCO Medical Device Registration<\/strong><\/a> for Paediatrics and Neonatology, which listed 136 medical devices that would be classified as medical devices pertaining to Paediatrics and Neonatology under the Medical Device Rules, 2017. <\/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-medical-device-registration-for-paediatrics-and-neonatology\/#Overview_of_Medical_Device_Rules_2017\" >Overview of Medical Device 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-medical-device-registration-for-paediatrics-and-neonatology\/#Classification_of_medical_devices_in_India\" >Classification of 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-3\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-medical-device-registration-for-paediatrics-and-neonatology\/#Classification_of_Paediatric_and_Neonatology_Medical\" >Classification of Paediatric and Neonatology Medical<\/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-medical-device-registration-for-paediatrics-and-neonatology\/#Documents_required_for_CDSCO_Medical_Device_Registration_for_Paediatrics_and_Neonatology\" >Documents required for CDSCO Medical Device Registration for Paediatrics and Neonatology<\/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-medical-device-registration-for-paediatrics-and-neonatology\/#Procedure_for_CDSCO_Medical_Device_Registration_for_Paediatrics_and_Neonatology\" >Procedure for CDSCO Medical Device Registration for Paediatrics and Neonatology<\/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-medical-device-registration-for-paediatrics-and-neonatology\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Overview_of_Medical_Device_Rules_2017\"><\/span>Overview of Medical Device Rules, 2017<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The government introduced the Medical device rules to differentiate medical devices and pharmaceuticals for <strong>CDSCO regulation<\/strong><sup><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Acts-Rules\/\"><strong>[1]<\/strong><\/a><\/sup>. The Medical device rules became effective on 1<sup>st<\/sup> January 2018. <\/p>\n\n\n\n<p>Medical Devices\nare specific devices or substances meant for internal or external use, to\ntreat, diagnose, mitigate or prevent any disorder or disease in humans or\nanimals. <\/p>\n\n\n\n<p>Medical devices\ncan also be specific substances notified by the government, which are meant to\naffect any kind of function or structure of the human body. It also includes\nsubstances that are used for in vitro diagnosis. Devices used as surgical\ndressings, bandages, staples, sutures, ligatures, and Blood and blood componens,\neither with or without anticoagulant, may also be categorized as medical\ndevices.<\/p>\n\n\n\n<p>The Medical Device Rules 2017 has also introduced a risk-based classification system for regulating medical devices, which is listed as follows- <\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  Medical device class\n  <\/td><td>\n  Risk level \n  <\/td><\/tr><tr><td>\n  Class-A\n  <\/td><td>\n  Low-level risk\n  <\/td><\/tr><tr><td>\n  Class-B\n  <\/td><td>\n  Low-Moderate level risk\n  <\/td><\/tr><tr><td>\n  Class-C\n  <\/td><td>\n  Moderate-High level risk\n  <\/td><\/tr><tr><td>\n  Class-D\n  <\/td><td>\n  High-level risk\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p>The classification, as mentioned above, is done based on the risk associated with each device. Risk types can be classified as low-level risk, low- moderate level risk, Moderate- High-level risk and High-level risk. All the medical devices falling into the respective categories are divided into classes A, B, C and D, respectively. The classification makes it much easier to identify the medical devices for their registration and intended use. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Classification_of_medical_devices_in_India\"><\/span>Classification of medical devices in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In India, Medical\ndevices are broadly identified into two types- <\/p>\n\n\n\n<ul><li>Notified medical devices <\/li><li>Non Notified medical devices <\/li><\/ul>\n\n\n\n<p>Earlier, there\nwas regulation on only notified medical devices, but later, CDSCO issued a\nnotice which invited the voluntary registration of non-notified medical devices\nby a given deadline. The deadline for voluntary registration of Class A and\nClass B medical devices is 1<sup>st<\/sup> October 2022, and the deadline for\nVoluntary registration of Class C and Class D medical devices is 1<sup>st<\/sup>\nOctober 2023. After the deadline is crossed, even the non-notified medical\ndevices shall fall on the ambit of mandatory registration. Earlier, only 37\nmedical devices were notified in India. Still, as the medical device sector has\nincreased in India, various unregulated medical devices are exposed to Indian\ncustomers, exposing multiple health and life threats. <\/p>\n\n\n\n<p>The Ministry of Health and Family Welfare was notified on 11<sup>th<\/sup> February 2020, inviting voluntary registration of all non-notified medical devices in India. Regarding this, another notice was issued on 3<sup>rd<\/sup> September 2020, which listed 24 new non-notified medical devices for CDSCO medical device registration. The list also notified about CDSCO Medical Device Registration for Paediatrics and Neonatology along with another medical device, as listed below \u2013 <\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  S.L. No.\n  <\/td><td>\n  Categories of medical device\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  <strong>20<\/strong>\n  <\/td><td>\n  <strong>Paediatric and Neonatology Medical<\/strong>\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_Paediatric_and_Neonatology_Medical\"><\/span>Classification of Paediatric and Neonatology Medical<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The DCGI\nnotified on 23<sup>rd<\/sup> August 2021, notifying the classification of\nmedical devices pertaining to <strong>Paediatric\nand Neonatology Medical <\/strong>under the Medical device rules 2017.<\/p>\n\n\n\n<p>According to the\nnotification, a total of 136 medical devices fall under the CDSCO Medical\nDevice Registration for Paediatrics and Neonatology category, listed according\nto the class risks and intended use. <\/p>\n\n\n\n<p>Following is the list of classifications for the same-<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Sr.no. <\/strong>\n  <\/td><td>\n  <strong>Name of Product <\/strong>\n  <\/td><td>\n  <strong>Class<\/strong>\n  <\/td><\/tr><tr><td>\n  1\n  <\/td><td>\n  Aerosol tent, paediatric\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  2\n  <\/td><td>\n  Airway Pressure \/Oxygen Monitor\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  3\n  <\/td><td>\n  Anaesthesia Facemask, single-use\n  (paediatric)\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  4\n  <\/td><td>\n  Anaesthesia Facemask, reusable\n  (paediatric)\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  5\n  <\/td><td>\n  Antimicrobial endotracheal tube,\n  paediatric\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  6\n  <\/td><td>\n  Assistive ergonomic chair\n  mobility base\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  7\n  <\/td><td>\n  Breathing circuit gas flow\n  sensor, reusable\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  8\n  <\/td><td>\n  Breathing circuit gas flow\n  sensor, single-use\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  9 \n  <\/td><td>\n  Cerebral oximeter\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  10\n  <\/td><td>\n  Circulating-air whole-body\n  heating\/cooling system pad, reusable\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  11\n  <\/td><td>\n  Circulating-air whole-body\n  heating\/cooling system pad, single-use, sterile\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  12\n  <\/td><td>\n  Circulating-fluid whole-body heating\/cooling\n  system pad, reusable\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  13\n  <\/td><td>\n  Circulating-fluid whole-body\n  heating\/cooling system pad, single-use\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  14\n  <\/td><td>\n  Closed-ended adhesive\n  infant\/paediatric urine collection bag\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  15 \n  <\/td><td>\n  Craniofacial bone screw, bio\n  absorbable\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  16\n  <\/td><td>\n  Craniofacial bone screw, non bio\n  absorbable, sterile\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  17 \n  <\/td><td>\n  Electric pad whole-body heating\n  system\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  18\n  <\/td><td>\n  Electric pad whole-body heating\n  system pad\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  19\n  <\/td><td>\n  Enteral feeding kit,\n  adult\/paediatric, sterile\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  20\n  <\/td><td>\n  Exhaled-gas oesophageal\n  intubation detector, paediatric\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  21\n  <\/td><td>\n  External counterpulsation\n  system, paediatric\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  22\n  <\/td><td>\n  External defibrillator\n  electrode, paediatric, reusable\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  23\n  <\/td><td>\n  External defibrillator\n  electrode, paediatric, single-use\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  24\n  <\/td><td>\n  Flexible bone nail, non-sterile\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  25 \n  <\/td><td>\n  Flexible bone nail, sterile\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  26 \n  <\/td><td>\n  Funnel chest remodelling bar\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  27\n  <\/td><td>\n  Growth-correction orthopaedic\n  fixation plate kit\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  28\n  <\/td><td>\n  Hepatic ultrasound elastography\n  system applicator\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  29 \n  <\/td><td>\n  Infant apnoea monitor\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  30 \n  <\/td><td>\n  Infant bed crib top\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  31 \n  <\/td><td>\n  Infant bed restraint\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  32 \n  <\/td><td>\n  Infant care table\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  33 \n  <\/td><td>\n  Infant heat shield\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  34 \n  <\/td><td>\n  Infant incubator control unit\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  35 \n  <\/td><td>\n  Infant incubator warming hood\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  36 \n  <\/td><td>\n  Infant inguinal hernia truss\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  37 \n  <\/td><td>\n  Infant limb immobilizer,\n  reusable\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  38\n  <\/td><td>\n  Infant limb immobilizer,\n  singleuse\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  39\n  <\/td><td>\n  Infant resuscitation cabinet\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  40\n  <\/td><td>\n  Infant resuscitation table\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  41 \n  <\/td><td>\n  Infant scale, electronic\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  42 \n  <\/td><td>\n  Infant sleep positioner\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  43 \n  <\/td><td>\n  Infant warmer\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  44 \n  <\/td><td>\n  Infant whole-body immobilizer,\n  reusable\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  45\n  <\/td><td>\n  Infant whole-body immobilizer,\n  single-use\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  46 \n  <\/td><td>\n  Infant\/regional-body warmer\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  47 \n  <\/td><td>\n  Infant-hammock bed mattress\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  48 \n  <\/td><td>\n  Infant-hammock bed mattress\n  overlay\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  49 \n  <\/td><td>\n  Internal defibrillator\n  electrode, paediatric\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  50 \n  <\/td><td>\n  Lacrimal intubation set\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  51 \n  <\/td><td>\n  Liquid crystal vein locator\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  52 \n  <\/td><td>\n  Micro laryngeal probe\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  53 \n  <\/td><td>\n  Multifunction cardiac electrode,\n  paediatric\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  54 \n  <\/td><td>\n  Neonatal chest percussor\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  55 \n  <\/td><td>\n  Neonatal CPAP unit\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  56\n  <\/td><td>\n  Neonatal electrocardiographic\n  electrode\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  57 \n  <\/td><td>\n  Neonatal hypothermia cot\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  58\n  <\/td><td>\n  Neonatal hypothermia cot heat\n  conduction mattress\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  59\n  <\/td><td>\n  Neonatal hypothermia cot\n  heat-retention pad\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  60 \n  <\/td><td>\n  Neonatal intensivecare\n  ventilator\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  61 \n  <\/td><td>\n  Neonatal kangaroo care garment\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  62 \n  <\/td><td>\n  Neonatal physiologic monitoring\n  system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  63 \n  <\/td><td>\n  Neonatal pulmonary surfactant\n  catheter\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  64\n  <\/td><td>\n  Neonatal\/paediatric heart rate\n  monitoring application software\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  65\n  <\/td><td>\n  Neonatal\/paediatric heart rate\n  monitoring hardware\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  66 \n  <\/td><td>\n  Nitric oxide delivery unit,\n  system-based\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  67\n  <\/td><td>\n  Non-rechargeable public\n  semi-automated external defibrillator electrode, paediatric\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  68\n  <\/td><td>\n  Open-ended adhesive\n  infant\/paediatric urine collection bag\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  69\n  <\/td><td>\n  Open-surgery manual linear\n  cutting stapler, reprocessed\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  70\n  <\/td><td>\n  Open-surgery manual linear\n  cutting stapler, reusable\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  71\n  <\/td><td>\n  Open-surgery manual linear\n  cutting stapler, single-use\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  72\n  <\/td><td>\n  Open-surgery manual linear\n  stapler, reusable\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  73\n  <\/td><td>\n  Open-surgery manual linear\n  stapler, single-use\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  74\n  <\/td><td>\n  Ophthalmic tonometer, battery\n  operated\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  75\n  <\/td><td>\n  Orthopaedic medialization\n  instrument\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  76\n  <\/td><td>\n  Oxygen administration hood,\n  paediatric\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  77\n  <\/td><td>\n  Oxygen administration tent,\n  neonatal\/paediatric\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  78 \n  <\/td><td>\n  Paediatric bed\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  79 \n  <\/td><td>\n  Paediatric blood donor set\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  80\n  <\/td><td>\n  Paediatric cardiopulmonary\n  bypass cannula\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  81 \n  <\/td><td>\n  Paediatric dental chair,\n  electric\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  82 \n  <\/td><td>\n  Paediatric dental chair,\n  mechanical\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  83 \n  <\/td><td>\n  Paediatric dorsiflexion slant\n  board\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  84 \n  <\/td><td>\n  Paediatric strabismus screening\n  scanner\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  85\n  <\/td><td>\n  Paediatric urine collection\/analysis\n  kit\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  86\n  <\/td><td>\n  Paediatric temperature\n  nasogastric\/orogastric tube\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  87 \n  <\/td><td>\n  Polyglyconate suture\n  <\/td><td>\n  D\n  <\/td><\/tr><tr><td>\n  88 \n  <\/td><td>\n  Blanket\/pad infant phototherapy\n  unit\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  89 \n  <\/td><td>\n  Flotation therapy bed, neonatal\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  90 \n  <\/td><td>\n  Mobile steam washer\/disinfector\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  91\n  <\/td><td>\n  Otoacoustic emission system,\n  battery-powered\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  92 \n  <\/td><td>\n  Otoacoustic emission system,\n  line-powered\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  93 \n  <\/td><td>\n  The overhead infant phototherapy\n  unit\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  94 \n  <\/td><td>\n  Phototherapy eye protector,\n  reusable\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  95 \n  <\/td><td>\n  Phototherapy eye protector,\n  single-use\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  96\n  <\/td><td>\n  Respiratory gas heating wire, infant\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  97\n  <\/td><td>\n  The stationary pneumatic\n  high-frequency ventilator respiration monitor\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  98 \n  <\/td><td>\n  Syringe pump\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  99\n  <\/td><td>\n  Thoracic electrical impedance\n  segmentography system\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  100\n  <\/td><td>\n  Thoracic electrical impedance\n  segmentography system electrode array\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  101\n  <\/td><td>\n  Transcutaneous intracranial\n  pressure sensor\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  102 \n  <\/td><td>\n  Wearable neonatal heart rate\n  meter\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  103 \n  <\/td><td>\n  Antimicrobial infant garment\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  104 \n  <\/td><td>\n  Birthing bath\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  105 \n  <\/td><td>\n  Boiling water sterilizer\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  106 \n  <\/td><td>\n  Newborn-infant bed\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  107 \n  <\/td><td>\n  Resuscitator face mask, reusable\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  108 \n  <\/td><td>\n  Resuscitator face mask,\n  single-use\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  109 \n  <\/td><td>\n  Warming infant bed, adjustable\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  110 \n  <\/td><td>\n  Warming infant bed,\n  non-adjustable\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  111 \n  <\/td><td>\n  Bedrail pad\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  112\n  <\/td><td>\n  Blanket\/pad infant phototherapy\n  unit tester\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  113 \n  <\/td><td>\n  Blood transfusion set, exchange\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  114 \n  <\/td><td>\n  Blue light radiometer\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  115 \n  <\/td><td>\n  Cardiac septostomy catheter,\n  balloon\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  116 \n  <\/td><td>\n  Cardiac septostomy catheter,\n  blade\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  117 \n  <\/td><td>\n  Conventional infant incubator\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  118\n  <\/td><td>\n  Cranial orthosis\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  119 \n  <\/td><td>\n  Home BPAP unit\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  120 \n  <\/td><td>\n  Multi-purpose saline solution\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  121 \n  <\/td><td>\n  Nappy changing table, portable\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  122 \n  <\/td><td>\n  Nasal aspirator, electric\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  123 \n  <\/td><td>\n  Open infant incubator\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  124 \n  <\/td><td>\n  Oral medicine dropper\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  125 \n  <\/td><td>\n  Oxygen breath analyzer\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  126 \n  <\/td><td>\n  Oxygen terminal unit\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  127\n  <\/td><td>\n  Pulmonary function analysis\n  system, paediatric\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  128 \n  <\/td><td>\n  Reactive-gel heating pad\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  129 \n  <\/td><td>\n  Respiratory apnoea monitoring\n  system\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  130 \n  <\/td><td>\n  Rocking infant bed, electric\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  131 \n  <\/td><td>\n  Skin transilluminator,\n  battery-powered\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  132 \n  <\/td><td>\n  Skin transilluminator,\n  line-powered\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  133\n  <\/td><td>\n  The teething device,\n  fluid-filled\n  <\/td><td>\n  B\n  <\/td><\/tr><tr><td>\n  134 \n  <\/td><td>\n  The teething device,\n  nonfluid-filled\n  <\/td><td>\n  A\n  <\/td><\/tr><tr><td>\n  135 \n  <\/td><td>\n  Transport infant incubator\n  <\/td><td>\n  C\n  <\/td><\/tr><tr><td>\n  136\n  <\/td><td>\n  Visual-reinforcement audiometry\n  reward 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_Medical_Device_Registration_for_Paediatrics_and_Neonatology\"><\/span>Documents required for CDSCO Medical Device Registration for Paediatrics and Neonatology<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following is\na checklist for CDSCO Medical Device Registration for Paediatrics and\nNeonatology:<\/p>\n\n\n\n<ul><li>Application form <\/li><li>Challan TR6<\/li><li>Power of Attorney<\/li><li>Certificate of quality\nassurance<\/li><li>C.E. Design accreditation<\/li><li>ISO 13485<\/li><li>Declaration of conformity<\/li><li>Schedule D(I)<\/li><li>Plant Master File<\/li><li>An Undertaking stating that the\ninformation is correct<\/li><li>Device master file <\/li><li>Free sale certificate<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_for_CDSCO_Medical_Device_Registration_for_Paediatrics_and_Neonatology\"><\/span>Procedure for CDSCO Medical Device Registration for Paediatrics and Neonatology<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is the procedure to apply for <strong>CDSCO Medical Device Registration for\nPaediatrics and Neonatology- <\/strong><\/p>\n\n\n\n<ol><li>The applicants must first check\nthe Medical Devices and IVDs list to see if a medical device has been notified\nor not. All non-notified medical devices must complete voluntary registration\nbefore the deadline to be marketed in India.<\/li><li>In cases where the medical\ndevice manufacturer is not an Indian, an Indian Authorized Agent is chosen on\nhis behalf. He is in charge of performing the manufacturer&#8217;s responsibilities.\nThe IAA conducts all of its official business in India and represents the\nmanufacturer in court.<\/li><li>All necessary paperwork and\ndocumentation must be submitted to the relevant authorities to obtain a\nregistration license.<\/li><li>The manufacturer receives the\nlicense once the authorities are pleased with all the paperwork and other\nrequirements.<\/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>The CDSCO Medical Device Registration for Paediatrics and Neonatology has been listed by the government for registration as medical devices. A notice was issued on 3<sup>rd<\/sup> September 2020, which listed 24 new devices which were to be included in the list of medical devices. The medical devices are required to be registered before being manufactured, imported, sold or marketed in India. However, the process of registration 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 an experienced professionals for CDSCO Medical Device Registration for Paediatrics and Neonatology 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\/classification-of-medical-devices-in-operation-theatre\/\">Classification of Medical Devices in Operation Theatre\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Central Drug Standard Control Organization, or CDSCO, is the national regulatory authority of India, headed by the DCGI. The Medical Device Rules, 2017, were introduced to regulate the laws and rules related to the Manufacture, Import, Clinical Investigation, Distribution and Sale of Medical devices in India. On 23rd August 2021, the DCGI notified CDSCO [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":50017,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2781],"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":3074,"readingTime":7,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49997"}],"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=49997"}],"version-history":[{"count":21,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49997\/revisions"}],"predecessor-version":[{"id":50019,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49997\/revisions\/50019"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/50017"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=49997"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=49997"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=49997"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}