{"id":6285,"date":"2026-05-11T16:21:56","date_gmt":"2026-05-11T10:51:56","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6285"},"modified":"2026-05-11T18:27:38","modified_gmt":"2026-05-11T12:57:38","slug":"cdsco-test-license-for-medical-devices","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/br-en\/cdsco-test-license-for-medical-devices\/","title":{"rendered":"CDSCO Test License for Medical Devices in India (MD-12, MD-13)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6285\" class=\"elementor elementor-6285\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-266a376e e-flex e-con-boxed e-con e-parent\" data-id=\"266a376e\" 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-e5eebbf elementor-widget elementor-widget-heading\" data-id=\"e5eebbf\" 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\">CDSCO Test License for Medical Devices in India (MD-12, MD-13)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-207b3a1 elementor-widget elementor-widget-text-editor\" data-id=\"207b3a1\" 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;\">Get your CDSCO Test License quickly and without delays. We help medical device manufacturers and importers obtain approval for testing, evaluation, and <\/span><span style=\"font-weight: 400;\">clinical investigations<\/span><span style=\"font-weight: 400;\"> under the Medical Devices Rules, 2017.<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">End-to-end documentation support<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">SUGAM portal submission handled<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Faster approval with expert guidance<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">To commence medical device manufacturing, one must initiate the process by submitting an application for a Test License via Form MD-12 on the designated online portal of the Ministry of Health and Family Welfare.<\/span><\/p><p><span style=\"font-weight: 400;\">This license specifically authorizes activities related to testing, evaluation, demonstration, and training. Following the application, the Ministry will issue the Test License in Form MD-13.<\/span><\/p><p><span style=\"font-weight: 400;\">Click here for <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/cdsco-registration\/cdsco-manufacturing-license\/\"><span style=\"font-weight: 400;\">CDSCO Manufacturing License for Medical Devices<\/span><\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0aaebc3 elementor-widget elementor-widget-heading\" data-id=\"0aaebc3\" 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 a CDSCO Test License?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e035bcb elementor-widget elementor-widget-text-editor\" data-id=\"e035bcb\" 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;\">A CDSCO Test License is an approval issued under the Medical Devices Rules, 2017 that allows manufacturers or importers to produce or import limited quantities of medical devices for:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Testing and evaluation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical investigation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Demonstration or training purposes<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Application Form: MD-12<\/li><li style=\"font-weight: 400;\" aria-level=\"1\">License Issued: MD-13<\/li><\/ul><p><span style=\"font-weight: 400;\">This license is mandatory before conducting testing activities on regulated medical devices in India.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-76c5a38 elementor-widget elementor-widget-heading\" data-id=\"76c5a38\" 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\">When Do You Need a CDSCO Test License?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dd979f9 elementor-widget elementor-widget-text-editor\" data-id=\"dd979f9\" 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;\">You need a test license if you are planning to:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Conduct clinical investigations in India<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Test product performance or safety<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Import devices for evaluation or validation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Demonstrate products to distributors or hospitals<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Train users before commercial launch<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1b8563c elementor-widget elementor-widget-heading\" data-id=\"1b8563c\" 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\">Types of CDSCO Test License\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ce7e9e elementor-widget elementor-widget-text-editor\" data-id=\"6ce7e9e\" 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>1. Test License for Manufacturing (MD-12 \u2192 MD-13)<\/strong><\/p><p><span style=\"font-weight: 400;\">Issued to Indian manufacturers to produce small quantities of devices for testing and evaluation<a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/en\/Home\/\" target=\"_blank\" rel=\"noopener\">.<\/a><\/span><\/p><p><strong>2. Test License for Import (MD-16 \u2192 MD-17)<\/strong><\/p><p><span style=\"font-weight: 400;\">Issued to importers for bringing medical devices into India for testing, demonstration, or clinical investigation.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4beeaff elementor-widget elementor-widget-heading\" data-id=\"4beeaff\" 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\">CDSCO Test License Process in India\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fba472e elementor-widget elementor-widget-text-editor\" data-id=\"fba472e\" 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 simplify the entire approval process for you:<\/span><\/p><p><strong>Step 1: SUGAM Portal Registration<\/strong><\/p><p><span style=\"font-weight: 400;\">Create and verify your account on the <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/cdsco-india\/\"><span style=\"font-weight: 400;\">CDSCO SUGAM portal<\/span><span style=\"font-weight: 400;\">.<\/span><\/a><\/p><p><strong>Step 2: Application Preparation (MD-12 \/ MD-16)<\/strong><\/p><p><span style=\"font-weight: 400;\">Prepare and compile all required technical and regulatory documents.<\/span><\/p><p><strong>Step 3: Documentation Submission<\/strong><\/p><p><span style=\"font-weight: 400;\">Upload application along with supporting documents.<\/span><\/p><p><strong>Step 4: Government Fee Payment<\/strong><\/p><p><span style=\"font-weight: 400;\">Pay applicable CDSCO fees.<\/span><\/p><p><strong>Step 5: CDSCO Review<\/strong><\/p><p><span style=\"font-weight: 400;\">Regulatory authority reviews your application and may raise queries.<\/span><\/p><p><strong>Step 6: License Grant (MD-13 \/ MD-17)<\/strong><\/p><p><span style=\"font-weight: 400;\">Approval is issued upon successful review.<\/span><\/p><p><span style=\"font-weight: 400;\">Typical Timeline: 4 to 8 weeks (depends on documentation quality and queries)<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-289ec70 elementor-widget elementor-widget-heading\" data-id=\"289ec70\" 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\">Documents Required for CDSCO Test License\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a569934 elementor-widget elementor-widget-text-editor\" data-id=\"a569934\" 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;\">To obtain a <a href=\"https:\/\/operonstrategist.com\/elevateplus\/cdsco-india\/\">CDSCO test license<\/a>, you need:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Device description and intended use<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Test protocol or clinical investigation plan<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Justification for quantity required<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\"><span style=\"font-weight: 400;\">ISO 13485 certificate<\/span><span style=\"font-weight: 400;\"> or QMS details<\/span><\/a><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Labeling and Instructions for Use (IFU)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Authorization letter (for importers, if applicable)<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Incomplete or incorrect documentation is the most common reason for delays<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-abb214b elementor-widget elementor-widget-heading\" data-id=\"abb214b\" 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\">Common Challenges in Getting CDSCO Test License\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e464348 elementor-widget elementor-widget-text-editor\" data-id=\"e464348\" 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;\">Many applicants face delays due to:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Incorrect device classification<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Incomplete or non-compliant documentation<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Errors in <\/span><span style=\"font-weight: 400;\">SUGAM portal submission<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">CDSCO queries and technical clarifications<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Poorly defined test protocols<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">We help you avoid these issues and get faster approvals.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bc65050 elementor-widget elementor-widget-heading\" data-id=\"bc65050\" 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\">Why Choose Operon Strategist?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-79a54aa elementor-widget elementor-widget-text-editor\" data-id=\"79a54aa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Strong experience in <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/cdsco-registration\/\"><span style=\"font-weight: 400;\">CDSCO regulatory approvals<\/span><\/a><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Dedicated team for medical device compliance<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">End-to-end support from documentation to approval<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Quick response to CDSCO queries<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Focus on faster turnaround and approval success<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-29355ba elementor-widget elementor-widget-heading\" data-id=\"29355ba\" 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\">FAQ's<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7063641 elementor-widget elementor-widget-n-accordion\" data-id=\"7063641\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1170\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1170\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is MD-12 and MD-13 in CDSCO? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1170\" class=\"elementor-element elementor-element-d88efd3 e-con-full e-flex e-con e-child\" data-id=\"d88efd3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e89a8d0 elementor-widget elementor-widget-text-editor\" data-id=\"e89a8d0\" 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 class=\"hover:entity-accent entity-underline inline cursor-pointer align-baseline\"><span class=\"whitespace-normal\">CDSCO<\/span><\/span> Form MD-12 is an application submitted to obtain a test license for manufacturing medical devices for testing, evaluation, demonstration, or training purposes. Form MD-13 is the license issued by CDSCO after approval of the MD-12 application.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1171\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1171\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How long does it take to get a CDSCO test license? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1171\" class=\"elementor-element elementor-element-bd37db6 e-con-full e-flex e-con e-child\" data-id=\"bd37db6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7aabcec elementor-widget elementor-widget-text-editor\" data-id=\"7aabcec\" 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 data-start=\"384\" data-end=\"563\">The timeline for obtaining a CDSCO test license generally ranges from 4 to 8 weeks, depending on the completeness of documentation, device category, and regulatory review process.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1172\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1172\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Can I sell medical devices under a test license? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1172\" class=\"elementor-element elementor-element-fbd5bf8 e-con-full e-flex e-con e-child\" data-id=\"fbd5bf8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1d6e58b elementor-widget elementor-widget-text-editor\" data-id=\"1d6e58b\" 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 data-start=\"625\" data-end=\"835\">No, medical devices manufactured or imported under a CDSCO test license cannot be commercially sold. They are permitted only for testing, evaluation, clinical investigation, demonstration, or training purposes.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1173\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1173\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Is a CDSCO test license mandatory? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1173\" class=\"elementor-element elementor-element-074abb8 e-con-full e-flex e-con e-child\" data-id=\"074abb8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a728ac3 elementor-widget elementor-widget-text-editor\" data-id=\"a728ac3\" 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 data-start=\"883\" data-end=\"1063\">Yes, a CDSCO test license is mandatory when manufacturing or importing medical devices for testing, evaluation, performance assessment, or demonstration before commercial approval.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1174\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1174\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is the validity of a CDSCO test license? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1174\" class=\"elementor-element elementor-element-6ad504d e-con-full e-flex e-con e-child\" data-id=\"6ad504d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cefbdc4 elementor-widget elementor-widget-text-editor\" data-id=\"cefbdc4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div class=\"flex max-w-full flex-col gap-4 grow\"><div class=\"min-h-8 text-message relative flex w-full flex-col items-end gap-2 text-start break-words whitespace-normal outline-none keyboard-focused:focus-ring [.text-message+&amp;]:mt-1\" dir=\"auto\" tabindex=\"0\" data-message-author-role=\"assistant\" data-message-id=\"b6e4feba-403c-487c-8d47-621a4582d5a3\" data-message-model-slug=\"gpt-5-5\" data-turn-start-message=\"true\"><div class=\"flex w-full flex-col gap-1 empty:hidden\"><div class=\"markdown prose dark:prose-invert wrap-break-word w-full light markdown-new-styling\"><p data-start=\"1122\" data-end=\"1237\" data-is-last-node=\"\" data-is-only-node=\"\">A CDSCO test license is generally valid for up to 3 years unless suspended or cancelled by the licensing authority.<\/p><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\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>Get your CDSCO Test License quickly and without delays. We help medical device manufacturers and importers obtain approval for testing, evaluation, and clinical investigations under the Medical Devices Rules, 2017. End-to-end documentation support SUGAM portal submission handled Faster approval with expert guidance To commence medical device manufacturing, one must initiate the process by submitting an [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6287,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[54],"tags":[],"class_list":["post-6285","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cdsco"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/posts\/6285","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/comments?post=6285"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/posts\/6285\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/media\/6287"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/media?parent=6285"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/categories?post=6285"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/br-en\/wp-json\/wp\/v2\/tags?post=6285"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}