{"id":51098,"date":"2022-12-02T15:04:18","date_gmt":"2022-12-02T09:34:18","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=51098"},"modified":"2025-01-17T18:10:04","modified_gmt":"2025-01-17T12:40:04","slug":"cdsco-registration-for-ophthalmic-medical-devices","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-ophthalmic-medical-devices\/","title":{"rendered":"CDSCO Registration for Ophthalmic Medical Devices"},"content":{"rendered":"\n<p>India is fast emerging as one of the most influential players in the healthcare sector. Many factors have led to India becoming the hub of affordable healthcare and innovative research and development in the field of medicine and medical devices. The Central Drugs Standards Control Organization or CDSCO, has been established by the Indian Government as the legislative and regulatory body for the management and control of <strong><a href=\"https:\/\/corpbiz.io\/medical-device-registration\">medical devices<\/a><\/strong> and pharmaceuticals in India. The CDSCO is headed by the Drug Controller General of India\/DCGI and the license is granted by either the State Licensing Authority\/the Central Licensing Authority based on the inherent risk of the medical devices. The Drugs and Cosmetics Act, 1940 regulates the sale, distribution, manufacture, import and export of medical devices in India. Medical devices and in-vitro diagnostics must mandatorily obtain requisite licenses from CDSCO and in accordance with the Drugs and Cosmetics Act, 1940 to, be marketed in India. Scroll down to check more information regarding <strong><a class=\"text-primary\" href=\"https:\/\/corpbiz.io\/cdsco-registration\">CDSCO Registration<\/a><\/strong> for Ophthalmic Medical Devices.<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-ophthalmic-medical-devices\/#What_are_Medical_Devices\" >What\nare Medical Devices?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-ophthalmic-medical-devices\/#What_are_Ophthalmic_Medical_Devices\" >What are Ophthalmic Medical Devices?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-ophthalmic-medical-devices\/#Who_Can_Apply_for_CDSCO_Registration_for_Ophthalmic_Medical_Devices\" >Who Can Apply for CDSCO Registration for\nOphthalmic Medical Devices?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/cdsco-registration-for-ophthalmic-medical-devices\/#Documents_Required_for_CDSCO_Registration_for_Ophthalmic_Medical_Devices\" >Documents\nRequired for CDSCO Registration for Ophthalmic 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-ophthalmic-medical-devices\/#Steps_Involved_in_CDSCO_Registration_for_Ophthalmic_Medical_Devices\" >Steps Involved in CDSCO Registration for\nOphthalmic 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-ophthalmic-medical-devices\/#Validity_and_Renewal_of_CDSCO_Registration_for_Ophthalmic_Medical_Devices\" >Validity and Renewal of CDSCO Registration for\nOphthalmic 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-ophthalmic-medical-devices\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_Medical_Devices\"><\/span><strong>What\nare Medical Devices?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Medical Devices as defined under the Medical\nDevices Amendment Rules, 2020, is: \u201cdevices\nused in general medical practice such medical apparatus, instruments, implants\nappliance, which are either used individually or in combination, and are\nintended to be specifically applied for human beings&nbsp; or animals and are further intended to obtain\nthe desired function by such means and for such purposes as provided below, but\nis not intended to meet the primary intended action on human body or animals by\nany pharmacological or immunological or metabolic means:<\/p>\n\n\n\n<ul>\n<li>Analysis, prevention, observation, treatment or\nmitigation of any disease or disorder<\/li>\n\n\n\n<li>Analysis, observation, treatment, mitigation or\nsupport for any injury or disability<\/li>\n\n\n\n<li>Examination, replacement or alteration or support\nin findings of the anatomy or a physiological process<\/li>\n\n\n\n<li>For supporting or sustaining life<\/li>\n\n\n\n<li>Decontamination of medical devices<\/li>\n\n\n\n<li>Conception-related equipment and medical devices<em>.&#8221;<\/em><\/li>\n<\/ul>\n\n\n\n<p><strong><em>Medical Devices Rules, 2017<\/em><\/strong> has classified medical devices into four\ncategories based on risk and usability of the medical devices, namely <strong><em>Class-A\n(low-risk devices), Class-B (low to moderate risk devices), Class-C (moderate\nto high-risk devices), Class-D (high-risk devices)<\/em><\/strong>. <\/p>\n\n\n\n<p>Medical devices are also categorized into two more categories for the purposes of registration, namely, notified devices and non-notified devices. There are 37 categories of medical devices which have been notified list which are regulated by the CDSCO. The CDSCO must provide the requisite approval for such devices to be marketed in the Indian market. The non-notified devices are devices which are not mentioned in notified list regulated by the CDSCO. These medical devices are listed on the CDSCO&#8217;s official website, and such devices require a <strong><a href=\"https:\/\/corpbiz.io\/noc-from-assistant-drug-controller\">No Objection Certificate<\/a><\/strong> from the CDSCO to be marketed freely in the Indian market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_Ophthalmic_Medical_Devices\"><\/span>What are Ophthalmic Medical Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Ophthalmic medical devices are used in ophthalmology\nand optometry and include invasive devices, non-invasive devices and\nimplantable devices which help in vision correction, surgery, and diagnosis of\nvarious eye diseases. There are about a hundred ophthalmic devices which fall\nunder Class A and Class B devices that are required to be registered under the\nnew licensing regime under the CDSCO in accordance with the Drugs &amp;\nCosmetics Act, 1940 and Medical Device Rules, 2017. This means that\nmanufacturers and importers wishing to trade such ophthalmic medical devices in\nthe Indian market need to mandatorily obtain the necessary license under the\nCDSCO regime. Any person or entity holding a license to manufacture under the\nDrugs and Cosmetics Act, 1940, can make an application to register and import\nophthalmic medical devices in India.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Who_Can_Apply_for_CDSCO_Registration_for_Ophthalmic_Medical_Devices\"><\/span>Who Can Apply for CDSCO Registration for\nOphthalmic Medical Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The following can apply for CDSCO Registration for Ophthalmic Medical Devices in India:<\/p>\n\n\n\n<ul>\n<li>A\ndomestic manufacturer: The manufacturer shall file an application under Form\nMD-3 and license under Form MD-5. For a loan license, the application shall be\nfiled under Form MD-4 and the license under Form MD-6.<\/li>\n<\/ul>\n\n\n\n<p>For a new medical device, the applicant shall\nfile application form MD-26 and license under Form MD-27 for a manufacturing\nlicense. For a manufacturer clinical license, the applicant shall file an\napplication form MD-22 and a license under Form MD-23. For a test license for a\nmanufacturer of a new medical device, the applicant shall file an application form\nMD-16 and license under Form MD-17.<\/p>\n\n\n\n<ul>\n<li>A\nforeign manufacturer with a registered office in India<\/li>\n\n\n\n<li>A\nsubsidiary of such a manufacturer<\/li>\n\n\n\n<li>An\nauthorized agent of such a manufacturer<\/li>\n\n\n\n<li>An\nimporter: The importer shall file application form MD-14 and license under Form\nMD-15 for an existing medical device. <\/li>\n<\/ul>\n\n\n\n<p>For a new medical device, the applicant shall file an application form MD-26 and license under Form MD-27 for an import license. For a clinical importer license, the applicant shall file an application form MD-22 and a license under Form MD-23. For a <strong><a href=\"https:\/\/corpbiz.io\/cdsco-test-license\">test license<\/a><\/strong> for an importer of a new medical device, the applicant shall file an application form MD-16 and license under Form MD-17.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_for_CDSCO_Registration_for_Ophthalmic_Medical_Devices\"><\/span><strong>Documents\nRequired for CDSCO Registration for Ophthalmic Medical Devices<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The documents required for CDSCO Registration\nfor Ophthalmic Medical Devices to be attached as follows:<\/p>\n\n\n\n<ul>\n<li>Application\nform.<\/li>\n\n\n\n<li>Quality\nassurance certificate <\/li>\n\n\n\n<li>ISO\n13485 certificate<\/li>\n\n\n\n<li>Plant\nmaster report <\/li>\n\n\n\n<li>Device\nmaster <\/li>\n\n\n\n<li>CE\ndesign certificate<\/li>\n\n\n\n<li>Marketability\ncertificate from Global Harmonization Task Force<\/li>\n\n\n\n<li>Certificate\nfrom a foreign government or a free sale certificate<\/li>\n\n\n\n<li>An\nundertaking as to the accuracy of the information given<\/li>\n<\/ul>\n\n\n\n<p><strong><em>The applicant ought to submit the following\ndetails under the plant master report and device master file of the medical\ndevice.<\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>Details\nas to names and addresses of the directors of the company, the address of the\nmanufacturing unit and the registered office.<\/li>\n\n\n\n<li>A\ncopy of the master file of the manufacturing site<\/li>\n\n\n\n<li>Details\nof manufacturing standards followed by the company and copies of any ISO\ncertifications granted to the company with respect to its manufacturing unit<\/li>\n\n\n\n<li>A\ncomprehensive explanation of the manufacturing process<\/li>\n\n\n\n<li>Details\nregarding the name, experience and qualifications of the technical staff involved\nin the manufacture of the medical device.<\/li>\n\n\n\n<li>Name\nof the brand under which the ophthalmic medical device is to be manufactured<\/li>\n\n\n\n<li>The\ncategory the device belongs to and a brief description of the device along with\nthe intended usage, the method of such usage and specific storage conditions of\nthe medical device.<\/li>\n\n\n\n<li>Details\nas to any variation in the shape &amp; size of the medical device, along with\nspecifications of the material used.<\/li>\n\n\n\n<li>Details\nas to any warnings, adverse effects, and precautions to be taken while using\nthe medical device and a summary indication of any problem which has been\npreviously reported.<\/li>\n\n\n\n<li>Qualitative\nand quantitative specifications of the device<\/li>\n\n\n\n<li>Details\nas to other equipment, accessories to be used in combination with the medical\ndevice and other necessary information for such usage.<\/li>\n\n\n\n<li>Labelling\ndetails as per the Drugs and Cosmetics Act, of 1940<\/li>\n\n\n\n<li>Details\nof the facilities to conduct tests in the manufacturing premises<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Steps_Involved_in_CDSCO_Registration_for_Ophthalmic_Medical_Devices\"><\/span>Steps Involved in CDSCO Registration for\nOphthalmic Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are\nthe steps involved in CDSCO Registration for Ophthalmic Medical Devices<strong>:<\/strong><\/p>\n\n\n\n<ul>\n<li><strong>Identify whether a medical device falls under the notified list or not<\/strong><\/li>\n<\/ul>\n\n\n\n<p>As mentioned above, if the medical device falls\nunder the notified list brought forth by CDSCO, it must be mandatorily\nregistered in accordance with the Drugs and Cosmetics Act, 1940 and <strong>Medical Device Rules, 2017<\/strong><sup><a class=\"text-primary\" href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Acts-and-rules\/Medical-Devices-Rules\/\"><strong>[1]<\/strong><\/a><\/sup> to be marketed in the\nIndian market. However, if the medical device does not fall on the notified\nlist, it must obtain a non-objection certificate from CDSCO to be deployed\nfreely in the Indian market.<\/p>\n\n\n\n<ul>\n<li><strong>Register\non the Sugam Portal and Fill out the Application Form<\/strong><\/li>\n<\/ul>\n\n\n\n<p>If the ophthalmic medical device falls under the notified list, the applicant or the manufacturer must register on the Sugam portal and fill in the appropriate application form and submit the required documents along with the prescribed fee as mentioned in the portal. The applicant is to submit the registration form on the Sugam portal to the Drugs Controller General of India. For a foreign manufacturer, before such application is filed, an authorized business entity or representative residing in India must be appointed which shall represent the manufacturer during, inter alia, the registration process, inspections, and device approvals. Such authorized representative must hold a license under Form 20B and Form 21B.<\/p>\n\n\n\n<ul>\n<li><strong>Assessment\nof Application and Documents<\/strong><\/li>\n<\/ul>\n\n\n\n<p>The application and documents submitted shall be\nscrutinized by the requisite licensing authority. For a new device, a subject expert\ncommittee shall be convened to assess the application and the documents\nsubmitted. The licensing authority may also ask for clarifications or\npresentations in case of an error or shortcoming if any and the applicant shall\nbe given the opportunity to provide clarifications.<\/p>\n\n\n\n<ul>\n<li><strong>Grant\nof License<\/strong><\/li>\n<\/ul>\n\n\n\n<p>After the licensing authority has assessed the\napplication and the documents, and has received clarifications when asked for\nshall grant the applicant the license. Once the manufacturer or the authorized\nrepresentative has obtained the license, they can further apply for the\nimporter license.<\/p>\n\n\n\n<p>The average time period expended in obtaining a CDSCO Registration for Ophthalmic Medical\nDevices is six to nine months. If the Drugs Controller General of India\nasks for an expert committee audit or a technical presentation, it may take an\nadditional three to six months to obtain the medical device registration.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Validity_and_Renewal_of_CDSCO_Registration_for_Ophthalmic_Medical_Devices\"><\/span>Validity and Renewal of CDSCO Registration for\nOphthalmic Medical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Once obtained, unless the CDSCO Registration for\nOphthalmic Medical Devices is cancelled by the Drugs Controller General of\nIndia, it shall be valid for a period of 3 years from the date of issuance of\nsuch certificate. <\/p>\n\n\n\n<p>The application for the renewal of CDSCO\nRegistration for Ophthalmic Medical Devices must be made nine months before the\nregistration certificate expires. The renewal application must be filed along\nwith the device file and the plant report if there are no changes in them.<\/p>\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>The Central Drugs Standards Control Organization or CDSCO, established by the Government of India, mandatorily requires that ophthalmic medical devices, which are now mentioned in the notified list regulated by CDSCO, must be registered in accordance with the Drugs and Cosmetics Act, 1940 and Medical Device Rules, 2017 for such devices to be deployed freely in the Indian market. Manufacturers and importers looking to sell, manufacture, export, import or distribute ophthalmic medical devices in the Indian market must be aware of the process, and legal and regulatory compliances involved and obtain the requisite license from the State Licensing Authority.<\/p>\n\n\n\n<p class=\"text-left\"><b>Read Our Article<\/b>: <mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/enterslice.com\/learning\/required-to-pay-professional-tax-or-not\/\">Know whether you are required to Pay Professional Tax or Not?<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>India is fast emerging as one of the most influential players in the healthcare sector. Many factors have led to India becoming the hub of affordable healthcare and innovative research and development in the field of medicine and medical devices. The Central Drugs Standards Control Organization or CDSCO, has been established by the Indian Government [&hellip;]<\/p>\n","protected":false},"author":47,"featured_media":51099,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2922],"acf":{"service_id":"508"},"authorName":"Sherin Jose","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/11\/MicrosoftTeams-image-4-e1668575330329.jpg","authorDescription":"Sherin has degrees in Law and English Literature from the University of Delhi. She is adept at legal research and writing and enjoys discussing and analysing important legal developments. Her primary interests lie in Corporate, FinTech and IPR Law and she is always on the lookout for exploring new developments in the area. She is an avid reader who loves classics and contemporary fiction. She likes to travel, bake and obsess over cat videos in her free time.","postViews":3334,"readingTime":6,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51098"}],"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\/47"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=51098"}],"version-history":[{"count":4,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51098\/revisions"}],"predecessor-version":[{"id":68360,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/51098\/revisions\/68360"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/51099"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=51098"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=51098"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=51098"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}