{"id":6354,"date":"2026-05-18T18:14:49","date_gmt":"2026-05-18T12:44:49","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6354"},"modified":"2026-05-18T18:14:49","modified_gmt":"2026-05-18T12:44:49","slug":"cdsco-notification-for-class-a-medical-devices","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/om-en\/cdsco-notification-for-class-a-medical-devices\/","title":{"rendered":"CDSCO Class A Medical Devices: Non-Sterile &#038; Non-Measuring Notification Guide (2026)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6354\" class=\"elementor elementor-6354\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-20989e1b e-flex e-con-boxed e-con e-parent\" data-id=\"20989e1b\" 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-37149a7c elementor-widget elementor-widget-heading\" data-id=\"37149a7c\" 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 Class A Medical Devices: Non-Sterile &#038; Non-Measuring Notification Guide (2026)<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7ab9c74e e-con-full e-flex e-con e-child\" data-id=\"7ab9c74e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-14f67849 elementor-widget elementor-widget-text-editor\" data-id=\"14f67849\" 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 CDSCO Class A medical devices category has received a major update to simplify the registration and licensing process. CDSCO has issued a notification to smoothen the licensing process for Class A medical devices, which are considered low to moderate risk devices such as surgical dressings.<\/span><\/p><p><span style=\"font-weight: 400;\">CDSCO issued this notification on 20 September 2022, explaining that CDSCO Class A medical devices that are non-sterile and non-measuring will require a license; however, the documentation requirements have been reduced.<br \/><\/span><\/p><p><span style=\"font-weight: 400;\">Under this update, CDSCO will introduce a new Chapter 3B in MDR 2017 for non-sterile and non-measuring devices. According to this, manufacturers and importers must self-certify that the product conforms to the essential principles checklist of safety and performance for such devices.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-597232c elementor-widget elementor-widget-heading\" data-id=\"597232c\" 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\">Key Points for CDSCO Class A Medical Devices\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d9089cf elementor-widget elementor-widget-text-editor\" data-id=\"d9089cf\" 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;\">1. <strong>Documents Required for CDSCO Class A Medical Devices<\/strong><\/span><\/p><p><span style=\"font-weight: 400;\">Documents need to be uploaded on the online portal. Manufacturers of CDSCO Class A medical devices (non-sterile and non-measuring) must provide an undertaking stating that the proposed device is non-sterile and non-measuring.<\/span><\/p><p><span style=\"font-weight: 400;\">As an importer, provide the following details:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Name and address of the importer<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Name and address of the manufacturing site<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Details of the medical devices<br \/><br \/><\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">2. <strong>Self-Certification Requirement<\/strong><\/span><\/p><p><span style=\"font-weight: 400;\">Manufacturers and importers of CDSCO Class A medical devices must self-certify compliance with the standards prescribed under MDR 2017.<\/span><\/p><p><span style=\"font-weight: 400;\">They must provide details such as:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Name and address of the manufacturing site<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Details of medical devices<br \/><br \/><\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">3. <strong>Manufacturing Site Documentation<\/strong><\/span><\/p><p><span style=\"font-weight: 400;\">As a manufacturer, you need to have a self-attested copy of the overseas manufacturing site or plant registration issued by a competent authority.<\/span><\/p><p><span style=\"font-weight: 400;\">4. I<strong>mporter Record Maintenance<\/strong><\/span><\/p><p><span style=\"font-weight: 400;\">Importers must maintain records of imports along with sales and distribution, as the licensing authority may verify these records and documents at any time.<\/span><\/p><p><span style=\"font-weight: 400;\">5.<strong> Undertaking Requirement<\/strong><\/span><\/p><p><span style=\"font-weight: 400;\">An undertaking must be duly signed by the importer or manufacturer stating that the information furnished is true and authenticated.<\/span><\/p><p><span style=\"font-weight: 400;\">6. <strong>Regulatory Relaxation Under MDR 2017<\/strong><\/span><\/p><p><span style=\"font-weight: 400;\">Chapter 4 and Chapter 5 will not be applicable to CDSCO Class A medical devices that are non-sterile and non-measuring.<\/span><\/p><p><span style=\"font-weight: 400;\">7. <strong>Record Maintenance and Audit Requirement<\/strong><\/span><\/p><p><span style=\"font-weight: 400;\">Manufacturers and importers should maintain all documents and records of the product at the site for onsite audit.<\/span><\/p><p><span style=\"font-weight: 400;\">Failure to maintain records may lead to license suspension.<\/span><\/p><p><span style=\"font-weight: 400;\">8. <strong>Important Note on CDSCO Class A Medical Devices<\/strong><\/span><\/p><p><span style=\"font-weight: 400;\">This notification is strictly applicable to CDSCO Class A medical devices that are non-sterile and non-measuring.<\/span><\/p><p><span style=\"font-weight: 400;\">9. <strong>Industry Impact of CDSCO Notification<\/strong><\/span><\/p><p><span style=\"font-weight: 400;\">This was long-awaited news by the industry to reduce regulatory requirements for CDSCO Class A medical devices. Several manufacturers were waiting for audits from government licensing authorities.<\/span><\/p><p><span style=\"font-weight: 400;\">With the introduction of online registration and self-declaration, this transition process has become easier and faster.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-32cbebb elementor-widget elementor-widget-heading\" data-id=\"32cbebb\" 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 Operon Strategist Helps in CDSCO Class A Medical Devices Registration\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1d3a3e2 elementor-widget elementor-widget-text-editor\" data-id=\"1d3a3e2\" 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;\">Navigating the regulatory pathway for CDSCO Class A medical devices can still be challenging. At <\/span><a href=\"https:\/\/operonstrategist.com\/\"><span style=\"font-weight: 400;\">Operon Strategist<\/span><\/a><span style=\"font-weight: 400;\">, we provide complete support for smooth and compliant registration.<\/span><\/p><p><strong>We assist you with:<\/strong><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/cdsco-registration\/\"><span style=\"font-weight: 400;\">CDSCO registration process<\/span><\/a><span style=\"font-weight: 400;\"> (<\/span><span style=\"font-weight: 400;\">CDSCO Registration Services<\/span><span style=\"font-weight: 400;\">)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Regulatory compliance (<\/span><span style=\"font-weight: 400;\">Medical Device Regulatory Consulting<\/span><span style=\"font-weight: 400;\">)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/\"><span style=\"font-weight: 400;\">QMS documentation<\/span><\/a><span style=\"font-weight: 400;\"> (<\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/iso-13485\/\"><span style=\"font-weight: 400;\">ISO 13485<\/span><\/a><span style=\"font-weight: 400;\"> Documentation Services<\/span><span style=\"font-weight: 400;\">)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Plant setup (<\/span><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/manufacturing-facility\/\"><span style=\"font-weight: 400;\">Medical Device Manufacturing Setup<\/span><\/a><span style=\"font-weight: 400;\">)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Global approvals (<\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/fda-510k\/\"><span style=\"font-weight: 400;\">FDA 510(k)<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/ce-marking\/\"><span style=\"font-weight: 400;\">CE Marking Services<\/span><\/a><span style=\"font-weight: 400;\">)<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-52d772c elementor-widget elementor-widget-heading\" data-id=\"52d772c\" 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\">FAQs <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c4c031a elementor-widget elementor-widget-n-accordion\" data-id=\"c4c031a\" 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-2060\" 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-2060\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What are CDSCO Class A medical devices? <\/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-2060\" class=\"elementor-element elementor-element-f73f818 e-con-full e-flex e-con e-child\" data-id=\"f73f818\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8013c58 elementor-widget elementor-widget-text-editor\" data-id=\"8013c58\" 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;\">CDSCO Class A medical devices are low-risk devices such as surgical dressings that have minimal impact on patient safety and require simplified regulatory controls.<\/span><\/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-2061\" 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-2061\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Do CDSCO Class A medical devices require a 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-2061\" class=\"elementor-element elementor-element-4b0fb07 e-con-full e-flex e-con e-child\" data-id=\"4b0fb07\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0fe8da4 elementor-widget elementor-widget-text-editor\" data-id=\"0fe8da4\" 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;\">Yes, CDSCO Class A medical devices require registration or license, but the process is simplified with reduced documentation and self-certification.<\/span><\/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-2062\" 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-2062\" >\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 CDSCO notification for non-sterile and non-measuring devices? <\/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-2062\" class=\"elementor-element elementor-element-24a6053 e-con-full e-flex e-con e-child\" data-id=\"24a6053\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-212cc21 elementor-widget elementor-widget-text-editor\" data-id=\"212cc21\" 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;\">CDSCO issued a notification on 20 September 2022 introducing simplified registration through self-certification for Class A non-sterile and non-measuring medical devices.<\/span><\/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-2063\" 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-2063\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is Chapter 3B in MDR 2017? <\/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-2063\" class=\"elementor-element elementor-element-bab34c8 e-con-full e-flex e-con e-child\" data-id=\"bab34c8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a5ad302 elementor-widget elementor-widget-text-editor\" data-id=\"a5ad302\" 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;\">Chapter 3B is a new provision introduced for CDSCO Class A medical devices that allows self-certification instead of a full regulatory audit.<\/span><\/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-2064\" 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-2064\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What documents are required for CDSCO Class A medical devices? <\/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-2064\" class=\"elementor-element elementor-element-dedc862 e-con-full e-flex e-con e-child\" data-id=\"dedc862\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3d74d9f elementor-widget elementor-widget-text-editor\" data-id=\"3d74d9f\" 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;\">Required documents include an undertaking, manufacturing site details, device details, and self-certification of compliance with MDR 2017.<\/span><\/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<\/div>\n\t\t\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\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>The CDSCO Class A medical devices category has received a major update to simplify the registration and licensing process. CDSCO has issued a notification to smoothen the licensing process for Class A medical devices, which are considered low to moderate risk devices such as surgical dressings. CDSCO issued this notification on 20 September 2022, explaining [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6434,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[57],"tags":[],"class_list":["post-6354","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\/6354","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=6354"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/posts\/6354\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/media\/6434"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/media?parent=6354"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/categories?post=6354"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/om-en\/wp-json\/wp\/v2\/tags?post=6354"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}