{"id":6766,"date":"2026-05-27T18:09:49","date_gmt":"2026-05-27T12:39:49","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6766"},"modified":"2026-05-27T18:09:49","modified_gmt":"2026-05-27T12:39:49","slug":"new-medical-device-import-license-md-26-27","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/om-en\/new-medical-device-import-license-md-26-27\/","title":{"rendered":"New Medical Device Import License (MD 26\/27)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6766\" class=\"elementor elementor-6766\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5815b2c9 e-flex e-con-boxed e-con e-parent\" data-id=\"5815b2c9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5a998816 elementor-widget elementor-widget-heading\" data-id=\"5a998816\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">New Medical Device Import License (MD 26\/27)<\/h1>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-79455652 e-flex e-con-boxed e-con e-parent\" data-id=\"79455652\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f662775 e-con-full e-flex e-con e-child\" data-id=\"f662775\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1d41e1a5 elementor-widget elementor-widget-heading\" data-id=\"1d41e1a5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Permission to Import a New Medical Device (MD 26\/27)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5dea2962 elementor-widget elementor-widget-text-editor\" data-id=\"5dea2962\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The market for medical devices in India is huge and has been growing steadily in recent years.\u202f A manufacturer from India must have both the registration certificate and the import license to import any medical devices into India. If a company wants to import its medical devices into India but does not already have a registered office, then\u202fa CDSCO-approved Indian agent must be appointed.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">In India, registration and a license are required for the import of medical devices. The approval of a competent body is necessary for the import of medical devices into India.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-24adb84e e-con-full e-flex e-con e-child\" data-id=\"24adb84e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-18eee0 e-con-full e-flex e-con e-child\" data-id=\"18eee0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2f58551e elementor-widget elementor-widget-heading\" data-id=\"2f58551e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">talk to our experts\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-13c085f7 elementor-widget elementor-widget-wpforms\" data-id=\"13c085f7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/om-en\/wp-json\/wp\/v2\/posts\/6766\" data-token=\"f90f4c38808f666071d8a9e075fe13da\" data-token-time=\"1779918293\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Text Phone Paragraph<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div><div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/posts\/6766\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5f6d723c e-flex e-con-boxed e-con e-parent\" data-id=\"5f6d723c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-22018c4c elementor-widget elementor-widget-text-editor\" data-id=\"22018c4c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The primary goal of device imports into India is to supply safe, effective, and high-quality products that comply with the highest standard of scientific development and regulatory processes. Operon Strategist provides high-quality consultancy services for medical device import licenses.<\/span><\/p><p><i><span style=\"font-weight: 400;\">You can also check our service page on the <\/span><\/i><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/cdsco-registration\/cdsco-import-license\/\"><i><span style=\"font-weight: 400;\">CDSCO import license<\/span><\/i><\/a><i><span style=\"font-weight: 400;\"> for more details.<\/span><\/i><\/p><p><span style=\"font-weight: 400;\">As per the medical device rule 2017, notified medical devices need to submit an application using form MD 26. The FORM MD 26 is required to grant approval for the importation of these medical devices.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-46e1c6e elementor-widget elementor-widget-heading\" data-id=\"46e1c6e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What are CDSCO Forms MD 26 and 27?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-035f01e elementor-widget elementor-widget-text-editor\" data-id=\"035f01e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Forms MD26 and MD27 are the names of the forms that a manufacturer or business owner can use to file an application and request permission to import a new medical device into the country. This medical device must be new to the Indian Market.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-200bec9 elementor-widget elementor-widget-heading\" data-id=\"200bec9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What Is the Difference Between MD 26 and MD 27?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-00f213e elementor-widget elementor-widget-text-editor\" data-id=\"00f213e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">MD26 is a sort of application form that is required to import medical devices that do not have predicate medical devices in India, whereas MD27 is a permission form to import the devices for sale or distribution in the market.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">One of the major benefits of this license is that CDSCO ensures that the new product coming into India is extensively validated and verified for its intended purpose. When CDSCO certifies a medical device, it passes quality assurance testing at an authorized laboratory &amp; has a quality certificate. This also provides the best results for the class that it represents. These types of qualified devices are safe to use and sell in the market.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7e3fae4 elementor-widget elementor-widget-heading\" data-id=\"7e3fae4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Who Can Apply for a New Medical Device Import License (MD 26\/27)?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7792021c e-con-full e-flex e-con e-child\" data-id=\"7792021c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1243202 elementor-widget elementor-widget-text-editor\" data-id=\"1243202\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">As per the CDSCO guidelines the Authorized Indian Agent who have license to manufacture medical devices for sell or distribute or wholesale license can apply for this license. Applicants need to apply to CLA (Central License Authority) via online portal of CDSCO.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-169f581 elementor-widget elementor-widget-heading\" data-id=\"169f581\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What Is the Procedure for Applying for an Import License for New Medical Devices?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-81d235f elementor-widget elementor-widget-text-editor\" data-id=\"81d235f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Follow these simple steps to submit an application for a new medical device import license:\u00a0<\/span><\/p><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Evaluate the product as per Indian MDR 2017\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Classify your product based on risk category\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Follow the checklist of form MD 26 and prepare the documents\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Appointment of Authorized agents\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Online registration\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Payment of fees <\/span><\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8fdeb07 elementor-widget elementor-widget-text-editor\" data-id=\"8fdeb07\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong>Simplify Medical Device Import License Process With Operon Strategist.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8f65863 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"8f65863\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/operonstrategist.com\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact Us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8d7cb5f elementor-widget elementor-widget-heading\" data-id=\"8d7cb5f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How Can an Operon Strategist Help You?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af064f9 elementor-widget elementor-widget-text-editor\" data-id=\"af064f9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">We support product understanding and classification, documentation preparation, submission, and licensing with CDSCO. Our team of experts expedites the overall process strategically and ensures the license in the best timelines.\u00a0<\/span><\/p><p><a href=\"https:\/\/operonstrategist.com\/contact-us\/\"><span style=\"font-weight: 400;\">Contact Operon Strategist<\/span><\/a><span style=\"font-weight: 400;\"> for expert guidance and quality-assured consultancy services. Feel free\u00a0 to <\/span><a href=\"https:\/\/api.whatsapp.com\/send?phone=919370283428&amp;text=I%20am%20looking%20for%20CDSCO,%20CE,%20SFDA,%20FDA,%20UKCA%20or%20Manufacturing%20plant%20setup.\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">WhatsApp<\/span><\/a><span style=\"font-weight: 400;\"> or <\/span><span style=\"font-weight: 400;\">Call +91 9370283428<\/span><span style=\"font-weight: 400;\"> or <\/span><span style=\"font-weight: 400;\">enquiry@operonstrategist.com<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Permission to Import a New Medical Device (MD 26\/27) The market for medical devices in India is huge and has been growing steadily in recent years.\u202f A manufacturer from India must have both the registration certificate and the import license to import any medical devices into India. If a company wants to import its medical [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6768,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[57],"tags":[],"class_list":["post-6766","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cdsco-category"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/posts\/6766","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/comments?post=6766"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/posts\/6766\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/media\/6768"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/media?parent=6766"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/categories?post=6766"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/tags?post=6766"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}