{"id":49506,"date":"2022-09-30T11:42:31","date_gmt":"2022-09-30T06:12:31","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=49506"},"modified":"2022-09-30T11:42:32","modified_gmt":"2022-09-30T06:12:32","slug":"cdsco-registration-for-dermatology-and-plastic-surgery-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-dermatology-and-plastic-surgery-medical-devices\/","title":{"rendered":"CDSCO Registration for Dermatology and Plastic Surgery Medical Devices"},"content":{"rendered":"\n<p>The Drugs Controller General of India (DCGI) issued a notice S.O. 648\n(E) &amp; GSR 102 (E) on 26th July 2021, regarding the classification of\nmedical devices related to Dermatological and Plastic Surgery, according to the\nprovisions of Medical Device Rules, 2017. The regulatory authorities have also\nmandated CDSCO Registration for Dermatology and Plastic Surgery Medical Devices.\nThe list of devices was issued by the DCGI, which contains a list of 55 medical\ndevices related to Dermatological &amp; Plastic Surgery use. The Medical\ndevices are categorized according to their risk classification. In this blog,\nwe will discuss CDSCO Registration for Dermatology and Plastic Surgery Medical\nDevices.<\/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-dermatology-and-plastic-surgery-medical-devices\/#CDSCO_Regulation_on_Medical_Device_Rules_2017\" >CDSCO Regulation\non 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-registration-for-dermatology-and-plastic-surgery-medical-devices\/#Risk_Based_Factors\" >Risk Based\nFactors<\/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-dermatology-and-plastic-surgery-medical-devices\/#CDSCO_Non-Notified_Medical_Device_Classification\" >CDSCO Non-Notified\nMedical Device Classification<\/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-dermatology-and-plastic-surgery-medical-devices\/#Classification_of_Dermatological_Plastic_Surgery_Medical_Devices\" >Classification\nof Dermatological &amp; Plastic Surgery Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-dermatology-and-plastic-surgery-medical-devices\/#Documents_Required_for_CDSCO_Registration_for_Dermatology_and_Plastic_Surgery_Medical_Devices\" >Documents Required\nfor CDSCO Registration for Dermatology and Plastic Surgery Medical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-dermatology-and-plastic-surgery-medical-devices\/#Procedure_for_CDSCO_Registration_for_Dermatology_and_Plastic_Surgery_Medical_Devices\" >Procedure for CDSCO\nRegistration for Dermatology and Plastic Surgery Medical Devices<\/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-dermatology-and-plastic-surgery-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CDSCO_Regulation_on_Medical_Device_Rules_2017\"><\/span>CDSCO Regulation\non Medical Device Rules, 2017<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>According to CDSCO, medical devices are classified into classes A,\nB, C and D based on the risk associated with the device, the intended use, and\nother requirements according to medical device rules, 2017.<\/p>\n\n\n\n<p>Any person who wants to apply for registration of medical devices\nfor import, manufacture, sale or distribution must follow the guidelines to be\nissued by the Ministry of Health and Family Welfare in the Central Government from\ntime to time and must take into consideration the technological changes or development\nin the field of medical devices and in vitro diagnostic medical devices.<\/p>\n\n\n\n<p>&#8220;A Medical Device can be any instrument, tool, apparatus,\nimplement, machine, appliance, implant, and reagent for in vitro use, software,\nmaterial, or any other related article,&#8221; according to the definition\nprovided by the FDA.<\/p>\n\n\n\n<p><strong>A medical device can be\none of two categories:<\/strong><\/p>\n\n\n\n<ul><li>Notified medical device<\/li><li>Not Notified medical device<\/li><\/ul>\n\n\n\n<p>Before 2006, manufacturers could sell medical devices without restriction. They previously advertised medical devices without being subject to any rules or laws. Later, as a result of <strong>FDA policy<\/strong><sup><a href=\"https:\/\/www.fda.gov\/tobacco-products\/products-guidance-regulations\/rules-regulations-and-guidance\"><strong>[1]<\/strong><\/a><\/sup>, CDSCO created the Indian Medical Device Regulations, which mandated that the import and export of medical devices into India be governed. <\/p>\n\n\n\n<p><strong>The functions performed by\nCDSCO are<\/strong>&#8211; <\/p>\n\n\n\n<ul><li>Medical Device Product\nRegistration<\/li><li>Setting up standards for\nMedical devices, Drugs, IVDs etc. <\/li><li>Setting up laws, regulations,\namendments and rules for Drugs, Medicines, Medical Devices, IVDs, etc. <\/li><li>Regulating the market\nauthorization of Drugs and Medical Devices.<\/li><li>Regulating the Clinical\nResearch and Drug trials in India. <\/li><li>Approval of license to\nmanufacture certain Drugs and other medicine-related devices <\/li><li>Regulating the standard of\nimported drugs in India. <\/li><li>Testing of Drugs through Central\nDrugs labs. <\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Risk_Based_Factors\"><\/span>Risk Based\nFactors<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The risks that medical devices possess are used as factors to\ncategorize them. The use and purpose of a medical device determine how and why it\nis categorized based on its risks. A larger group of medical devices, such as cannulas\nand stents, are divided into smaller groups with more specific names according\nto CDSCO&#8217;s Different Classes of Medical Devices.<\/p>\n\n\n\n<p><strong>Indian Classification of\nMedical Devices:<\/strong><\/p>\n\n\n\n<p>Medical and IVD devices are categorized in India using various\nsystems, each of which has four classes based on how dangerous the machines\nare. There are four different types of Indian medical devices listed in the\ntable below:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Medical device class<\/strong>\n  <\/td><td>\n  <strong>Risk level<\/strong>\n  <\/td><\/tr><tr><td>\n  <strong>Class-A<\/strong>\n  <\/td><td>\n  Low-level risk\n  <\/td><\/tr><tr><td>\n  <strong>Class-B<\/strong>\n  <\/td><td>\n  Low-Moderate level risk\n  <\/td><\/tr><tr><td>\n  <strong>Class-C<\/strong>\n  <\/td><td>\n  Moderate-High level risk\n  <\/td><\/tr><tr><td>\n  <strong>Class-D<\/strong>\n  <\/td><td>\n  High-level risk\n  <\/td><\/tr><\/tbody><\/table>\n\n\n\n<p>Different Classes of Medical Devices have been divided into four\ndifferent categories by the Medical Rules, 2017. Any business that aims to\nmanufacture such devices for distribution or sale must submit an application to\nCDSCO for a Manufacturer&#8217;s Licence. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"CDSCO_Non-Notified_Medical_Device_Classification\"><\/span>CDSCO Non-Notified\nMedical Device Classification<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Earlier, only 37 medical devices\nwere regulated by CDSCO. But in a recent notification, there has been a list of\nnon-notified devices that falls under the definition of Medical Devices in\nIndia. The Ministry of Health and Family Welfare has recently made an amendment\nto the Medical Device Rules, 2017. According to a notice issued by CDSCO on 11<sup>th<\/sup>\nFebruary 2020, it was notified that all medical devices are to be voluntarily\nregistered with CDSCO before the given deadline. After the deadline,\nregistration will be made mandatory for those devices. The deadline for voluntarily\nregistering medical devices of Class A and B is 1<sup>st<\/sup> October 2022,\nand for Medical devices of class C and D is 1<sup>st<\/sup> October 2023.&nbsp; <\/p>\n\n\n\n<p>CDSCO issued another notice on 3<sup>rd<\/sup>\nSeptember 2020, where it included 24 non-notified medical devices for the\npurpose of registration. CDSCO Registration for Dermatology and Plastic Surgery\nMedical Devices is also a part of the list. The classification of 24 newly\nlisted non- notified devices are- <\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>S.L. No.<\/strong>\n  <\/td><td>\n  <strong>Categories of medical device<\/strong>\n  <\/td><\/tr><tr><td>\n  1\n  <\/td><td>\n  Anaesthesiology&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  2\n  <\/td><td>\n  Pain 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  <strong>19<\/strong>\n  <\/td><td>\n  <strong>Dermatology and Plastic Surgery<\/strong>\n  <\/td><\/tr><tr><td>\n  20\n  <\/td><td>\n  Paediatric and Neonatology Medical\n  <\/td><\/tr><tr><td>\n  21\n  <\/td><td>\n  Oncology&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; \n  <\/td><\/tr><tr><td>\n  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_Dermatological_Plastic_Surgery_Medical_Devices\"><\/span>Classification\nof Dermatological &amp; Plastic Surgery Medical Devices <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following is the classification of Dermatological and Plastic\nSurgery Medical Devices:<\/p>\n\n\n\n<table class=\"table table-bordered\"><tbody><tr><td>\n  <strong>Sr. No.<\/strong>\n  <\/td><td>\n  <strong>Medical Device Name<\/strong>\n  <\/td><td>\n  <strong>Risk Class<\/strong>\n  <\/td><\/tr><tr><td>\n  1 \n  <\/td><td>\n  Organ bag\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  2 \n  <\/td><td>\n  Surgical camera and accessories\n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  3 \n  <\/td><td>\n  Implantable ligating clip \n  <\/td><td>\n  C \n  <\/td><\/tr><tr><td>\n  4 \n  <\/td><td>\n  Laser surgical instrument for plastic\n  surgery, general and dermatology\n  <\/td><td>\n  C \n  <\/td><\/tr><tr><td>\n  5 \n  <\/td><td>\n  Low energy ultrasound wound\n  cleaner\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  6 \n  <\/td><td>\n  Non-powdered surgeon&#8217;s glove.\n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  7 \n  <\/td><td>\n  Surgical drape and drape\n  accessories\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  8 \n  <\/td><td>\n  Suture retention device \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  9 \n  <\/td><td>\n  Ultraviolet lamp for dermatologic\n  disorders\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  10 \n  <\/td><td>\n  Wound autofluorescence imaging\n  device \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  11 \n  <\/td><td>\n  Battery-powered trephine system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  12 \n  <\/td><td>\n  Carbon dioxide laser \n  <\/td><td>\n  C \n  <\/td><\/tr><tr><td>\n  13 \n  <\/td><td>\n  The colonoscopy, General &amp;\n  Plastic Surgery \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  14 \n  <\/td><td>\n  Copper vapour laser \n  <\/td><td>\n  C \n  <\/td><\/tr><tr><td>\n  15 \n  <\/td><td>\n  Cryosurgical unit and accessories \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  16 \n  <\/td><td>\n  Dermal dilator \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  17 \n  <\/td><td>\n  Dermatome \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  18\n  <\/td><td>\n  Dermatome skin approximation tape \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  19 \n  <\/td><td>\n  Drape adhesive\n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  20 \n  <\/td><td>\n  Electrically powered trephine\n  system\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  21 \n  <\/td><td>\n  Electrosurgical cutting and\n  coagulation device and accessories \n  <\/td><td>\n  C \n  <\/td><\/tr><tr><td>\n  22 \n  <\/td><td>\n  Electrosurgical device for\n  over-the-counter aesthetic use \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  23\n  <\/td><td>\n  Esophagoscope, General &amp;\n  Plastic Surgery\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  24 \n  <\/td><td>\n  Eye pad\n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  25 \n  <\/td><td>\n  Gas-powered dermatome\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  26 \n  <\/td><td>\n  Gas-powered surgical saw\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  27 \n  <\/td><td>\n  Gas-powered trephine system \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  28 \n  <\/td><td>\n  Gastroscope, General &amp; Plastic\n  Surgery \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  29 \n  <\/td><td>\n  General electrosurgical unit \n  <\/td><td>\n  C \n  <\/td><\/tr><tr><td>\n  30 \n  <\/td><td>\n  Hemostatic knife \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  31 \n  <\/td><td>\n  Hydrophilic wound dressing\n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  32 \n  <\/td><td>\n  Implantable staple \n  <\/td><td>\n  C \n  <\/td><\/tr><tr><td>\n  33 \n  <\/td><td>\n  Internal tissue marker\n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  34 \n  <\/td><td>\n  Irrigating wound retractor device\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  35 \n  <\/td><td>\n  A laparoscope, General &amp;\n  Plastic Surgery \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  36 \n  <\/td><td>\n  Laparoscopy Tray\n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  37 \n  <\/td><td>\n  Liposuction catheter \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  38\n  <\/td><td>\n  Manual operating table and\n  accessories and manual operating chair and accessories \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  39 \n  <\/td><td>\n  Manually-operated dermatome \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  40 \n  <\/td><td>\n  Occlusive wound dressing\n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  41 \n  <\/td><td>\n  Plastic surgery osteotome \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  42 \n  <\/td><td>\n  Powered corneal trephine \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  43 \n  <\/td><td>\n  Powered dermatome \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  44 \n  <\/td><td>\n  Powered suction pump\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  45 \n  <\/td><td>\n  Removable skin clip \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  46 \n  <\/td><td>\n  Removable skin staple \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  47\n  <\/td><td>\n  Reusable dermatome blade \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  48 \n  <\/td><td>\n  Single-use dermatome blade \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  49 \n  <\/td><td>\n  Skin marker \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  50 \n  <\/td><td>\n  Skin Stapler\n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  51 \n  <\/td><td>\n  Soft tissue trephine \n  <\/td><td>\n  B \n  <\/td><\/tr><tr><td>\n  52 \n  <\/td><td>\n  Surgical apparel\n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  53 \n  <\/td><td>\n  Surgical guillotine \n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  54\n  <\/td><td>\n  Surgical lamp Identification\n  <\/td><td>\n  A \n  <\/td><\/tr><tr><td>\n  55 \n  <\/td><td>\n  Surgical microscope and accessories\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_Dermatology_and_Plastic_Surgery_Medical_Devices\"><\/span>Documents Required\nfor CDSCO Registration for Dermatology and Plastic Surgery Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following is a list of the requirements for CDSCO Registration\nfor Dermatology and Plastic Surgery Medical Devices:<\/p>\n\n\n\n<ul><li>Application Form <\/li><li>Challan TR6<\/li><li>ISO 13485<\/li><li>Power of Attorney<\/li><li>An Undertaking stating that\nonly accurate information is provided<\/li><li>Certificate of Quality Assurance<\/li><li>C.E. Design Accreditation<\/li><li>Declaration of Conformity<\/li><li>Schedule D(I)<\/li><li>Master Plant File<\/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_Registration_for_Dermatology_and_Plastic_Surgery_Medical_Devices\"><\/span>Procedure for CDSCO\nRegistration for Dermatology and Plastic Surgery Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The process for CDSCO Registration for Dermatology and Plastic\nSurgery Medical Devices in India is listed below. &#8211;<\/p>\n\n\n\n<ol><li><strong>Identify whether the medical devices need to be registered:<\/strong> To determine whether a medical device has been notified or not, the\napplicant must first check the Medical Devices and IVDs list. Before being\nmarketed in India, all non- notified medical devices notified must first obtain\nvoluntary registration before the given deadline. <\/li><li><strong>Medical Device Classification Based on Risk:<\/strong> Based on the risks associated, the medical devices must be\nregistered with CDSCO.<\/li><li><strong>Indian Authorized Agent Appointment:<\/strong> In\nthe case where the manufacturer is not Indian, an IAA, or Indian Authorized\nAgent, is appointed. The IAA represents the manufacturer in court and carries\nout all of their official business in India.<\/li><li><strong>Documentation procedure:<\/strong> To obtain a\nregistration license, all required paperwork must be submitted to the\nappropriate authorities.<\/li><li><strong>Obtaining Registration and License:<\/strong> The\nmanufacturer receives the registration license after submitting all required\npaperwork to the appropriate authorities.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Central Drug Standard Control Organization has issued a new risk-based Classification for <a href=\"https:\/\/corpbiz.io\/cdsco-registration\"><strong>CDSCO Registration<\/strong><\/a> for Dermatology and Plastic Surgery Medical Devices in India to comply with the latest Medical Device Rules in India. The notice was issued on 3<sup>rd<\/sup> September 2020, which listed that Dermatology and Plastic Surgery Medical Devices are to be classified as Non-Notified Medical Devices by CDSCO. The classification includes 24 medical devices. It is always advisable to connect with an experienced professional for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices to save time and money wasted on any kind of 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\/how-to-import-cosmetics-from-usa\/\">How to Import Cosmetics from USA?\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Drugs Controller General of India (DCGI) issued a notice S.O. 648 (E) &amp; GSR 102 (E) on 26th July 2021, regarding the classification of medical devices related to Dermatological and Plastic Surgery, according to the provisions of Medical Device Rules, 2017. The regulatory authorities have also mandated CDSCO Registration for Dermatology and Plastic Surgery [&hellip;]<\/p>\n","protected":false},"author":45,"featured_media":49515,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2756],"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":3494,"readingTime":6,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49506"}],"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=49506"}],"version-history":[{"count":9,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49506\/revisions"}],"predecessor-version":[{"id":49516,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/49506\/revisions\/49516"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/49515"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=49506"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=49506"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=49506"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}