{"id":6632,"date":"2026-05-25T15:55:57","date_gmt":"2026-05-25T10:25:57","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6632"},"modified":"2026-05-25T15:59:31","modified_gmt":"2026-05-25T10:29:31","slug":"cdsco-registration-for-dental-medical-devices-class-c-and-class-d","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/sa-en\/cdsco-registration-for-dental-medical-devices-class-c-and-class-d\/","title":{"rendered":"CDSCO Registration for Dental Medical Devices (Class C and Class D)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6632\" class=\"elementor elementor-6632\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2925358a e-flex e-con-boxed e-con e-parent\" data-id=\"2925358a\" 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-f9808 elementor-widget elementor-widget-heading\" data-id=\"f9808\" 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 Registration for Dental Medical Devices (Class C and Class D)<\/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-635cb965 e-flex e-con-boxed e-con e-parent\" data-id=\"635cb965\" 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-3ebcf58c e-con-full e-flex e-con e-child\" data-id=\"3ebcf58c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7eb1655c elementor-widget elementor-widget-heading\" data-id=\"7eb1655c\" 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\">Dental Medical Device<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4a9222f4 elementor-widget elementor-widget-text-editor\" data-id=\"4a9222f4\" 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;\">Dental medical devices are tools, instruments, and equipment used by dental professionals to diagnose, treat, and manage various oral health conditions. These devices play a crucial role in maintaining oral hygiene, preventing dental issues, and performing dental procedures effectively.\u00a0 Here are some common types of dental medical devices. The Central Drugs Standard Control Organization (CDSCO), a regulatory body in India, ensures the safety, efficacy, and quality of dental medical devices by implementing stringent standards and regulations.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">dental medical devices are classified based on risk into different categories, ranging from low-risk devices, such as dental mirrors and examination gloves, to higher-risk devices like dental implants, each with distinct regulatory requirements.<\/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-4e1c16c2 e-con-full e-flex e-con e-child\" data-id=\"4e1c16c2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-3887661a e-con-full e-flex e-con e-child\" data-id=\"3887661a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-17e80cec elementor-widget elementor-widget-heading\" data-id=\"17e80cec\" 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<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2245a612 elementor-widget elementor-widget-wpforms\" data-id=\"2245a612\" 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=\"\/sa-en\/wp-json\/wp\/v2\/posts\/6632\" data-token=\"76396b20a72216508aa08046c190e1de\" data-token-time=\"1780381159\"><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><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\" 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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-288a91a6 e-flex e-con-boxed e-con e-parent\" data-id=\"288a91a6\" 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-2c6d2da1 elementor-widget elementor-widget-heading\" data-id=\"2c6d2da1\" 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\">Compulsory Registration for Class C and D Medical Devices\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1068853 elementor-widget elementor-widget-text-editor\" data-id=\"1068853\" 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;\">Starting from October 1, 2023, \u201cClass C and Class D\u201d CDSCO Registration for Dental Medical Devices, which were previously required to be registered, will now need to follow a licensing regime as per <\/span><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/system\/modules\/CDSCO.WEB\/elements\/download_file_division.jsp?num_id=MTAwMjM=\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">the recent circular<\/span><\/a><span style=\"font-weight: 400;\"> issued by the Central Drugs Standard Control Organization (CDSCO) on April 12, 2023. This transition aligns with GSR 102(E) dated February 11, 2020.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Manufacturers and importers seeking a manufacturing or import license for these devices should apply online via the CDSCO portal. The application process must include necessary documents and fees, following the guidelines of the Medical Devices Rules (MDR) 2017.<\/span><\/p>\t\t\t\t\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-5c4c256 e-flex e-con-boxed e-con e-parent\" data-id=\"5c4c256\" 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-95fc6f6 elementor-widget elementor-widget-heading\" data-id=\"95fc6f6\" 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\">List of Class C and Class D Dental Medical Device\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fccea09 elementor-widget elementor-widget-text-editor\" data-id=\"fccea09\" 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;\">Some of the Class C and Class D Dental Medical Devices are listed below \u2013\u00a0<\/span><\/p><table><tbody><tr><td><p><span style=\"font-weight: 400;\">Sr. No.\u00a0\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Device Name\u00a0\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Risk Class\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">1.\u00a0\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Dental amalgam\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">C\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">2.\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Dental amalgam alloy\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">C\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">3.\u00a0\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Dental amalgam mercury\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">C\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">4.\u00a0\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Transmandibular implant\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">C\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">5.\u00a0\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Dental surgical procedure kit, medicated, reusable\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">C\u00a0<\/span><\/p><\/td><\/tr><\/tbody><\/table><p><span style=\"font-weight: 400;\">Examine the compilation of <\/span><a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/system\/modules\/CDSCO.WEB\/elements\/download_file_division.jsp?num_id=NjQ1MA==\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Class C and D Dental Medical Devices<\/span><\/a><span style=\"font-weight: 400;\"> presented here.\u00a0<\/span><\/p>\t\t\t\t\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-287cf12 e-flex e-con-boxed e-con e-parent\" data-id=\"287cf12\" 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-bdca80a elementor-widget elementor-widget-heading\" data-id=\"bdca80a\" 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 Manufacturing License of Class C and Class D Dental Medical Devices\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ac2c70d elementor-widget elementor-widget-text-editor\" data-id=\"ac2c70d\" 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;\">Gaining a <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/cdsco-india\/\"><span style=\"font-weight: 400;\">manufacturing license from CDSCO<\/span><\/a><span style=\"font-weight: 400;\"> entails a holistic commitment to compliance, covering meticulous facility standards, methodical protocols, and exhaustive documentation. This unwavering approach guarantees the creation of medical devices that uphold rigorous benchmarks for quality and safety.\u00a0<\/span><\/p>\t\t\t\t\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-3b2a36e e-flex e-con-boxed e-con e-parent\" data-id=\"3b2a36e\" 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-5f138ab elementor-widget elementor-widget-heading\" data-id=\"5f138ab\" 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 Import License of Class C and Class D Dental Medical Devices\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f66e97 elementor-widget elementor-widget-text-editor\" data-id=\"0f66e97\" 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;\">Securing a <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/cdsco-registration\/cdsco-import-license\/\"><span style=\"font-weight: 400;\">CDSCO import license<\/span><\/a><span style=\"font-weight: 400;\"> necessitates obtaining Approval and Free Sale Certificates from recognized global regulatory bodies like the USA, EU, Japan, Australia, and Canada. These certificates affirm compliance with international quality standards and unrestricted market approval, underscoring their vital role in upholding safety and import quality.<\/span><\/p><p><span style=\"font-weight: 400;\">When it comes to obtaining your <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/cdsco-registration\/\"><span style=\"font-weight: 400;\">CDSCO Registration <\/span><\/a><span style=\"font-weight: 400;\">for Dental medical devices, Operon Strategist stands as your reliable ally.<\/span><\/p>\t\t\t\t\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-e2d362d e-flex e-con-boxed e-con e-parent\" data-id=\"e2d362d\" 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-1e9cc4b elementor-widget elementor-widget-heading\" data-id=\"1e9cc4b\" 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 can help you<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1660bc4 elementor-widget elementor-widget-text-editor\" data-id=\"1660bc4\" 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>When it comes to CDSCO registration for Class C and Class D dental medical devices, <span class=\"\" data-state=\"closed\"><a class=\"decorated-link\" href=\"https:\/\/operonstrategist.com?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener\">Operon Strategist<\/a><\/span> provides complete regulatory support to manufacturers, importers, and medical device companies. Our team assists with <a href=\"https:\/\/operonstrategist.com\/elevateplus\/cdsco-india\/\">CDSCO manufacturing<\/a> and import license applications, device classification, technical documentation, Device Master File (DMF) preparation, Plant Master File (PMF) preparation, <a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\">ISO 13485 compliance<\/a>, regulatory gap analysis, and end-to-end submission support through the CDSCO portal. We also offer guidance for medical device registration, <a href=\"https:\/\/operonstrategist.com\/elevateplus\/ce-marking-eu-mdr-ivdr\/\">CE Marking<\/a>, <a href=\"https:\/\/operonstrategist.com\/elevateplus\/us-fda-510k-qsmr-registration\/\">FDA compliance<\/a>, <a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\">quality management systems<\/a>, <a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\">clean room setup<\/a>, and turnkey medical device manufacturing projects. With strong regulatory expertise and practical industry knowledge, Operon Strategist helps businesses simplify the licensing process and achieve faster regulatory compliance for dental medical devices in India.<\/p>\t\t\t\t\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-58da679e e-con-full e-flex e-con e-child\" data-id=\"58da679e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-19cb81dc elementor-widget elementor-widget-heading\" data-id=\"19cb81dc\" 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<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d08850b elementor-widget elementor-widget-n-accordion\" data-id=\"6d08850b\" 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-1820\" 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-1820\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is CDSCO registration for dental 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-1820\" class=\"elementor-element elementor-element-236710ba e-con-full e-flex e-con e-child\" data-id=\"236710ba\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4eaf54a6 elementor-widget elementor-widget-text-editor\" data-id=\"4eaf54a6\" 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=\"140\" data-end=\"425\">CDSCO registration is the regulatory approval process required for manufacturing, importing, and marketing dental medical devices in India. It ensures that dental devices comply with the safety, quality, and performance requirements defined under the Medical Devices Rules (MDR), 2017.<\/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-1821\" 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-1821\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which dental medical devices fall under Class C and Class D? <\/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-1821\" class=\"elementor-element elementor-element-63d06b9 e-con-full e-flex e-con e-child\" data-id=\"63d06b9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4c30e72 elementor-widget elementor-widget-text-editor\" data-id=\"4c30e72\" 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=\"492\" data-end=\"744\">Class C and Class D dental medical devices are categorized as moderate to high-risk devices. Examples include dental amalgam, dental amalgam alloy, dental amalgam mercury, transmandibular implants, and medicated reusable dental surgical procedure kits.<\/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-1822\" 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-1822\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Is CDSCO licensing mandatory for Class C and Class D dental 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-1822\" class=\"elementor-element elementor-element-2b293f8b e-con-full e-flex e-con e-child\" data-id=\"2b293f8b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f47ea6f elementor-widget elementor-widget-text-editor\" data-id=\"f47ea6f\" 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=\"827\" data-end=\"1009\">Yes. From October 1, 2023, Class C and Class D dental medical devices require a manufacturing or import license under the CDSCO licensing regime as per the latest CDSCO notification.<\/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-1823\" 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-1823\" >\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 a CDSCO manufacturing 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-1823\" class=\"elementor-element elementor-element-1e7d8251 e-con-full e-flex e-con e-child\" data-id=\"1e7d8251\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6e5ff296 elementor-widget elementor-widget-text-editor\" data-id=\"6e5ff296\" 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=\"1951\" data-end=\"1992\">The required documents generally include:<\/p><ul data-start=\"1993\" data-end=\"2217\"><li data-section-id=\"15disoj\" data-start=\"1993\" data-end=\"2016\"><a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\">ISO 13485 certificate<\/a><\/li><li data-section-id=\"x2zgui\" data-start=\"2017\" data-end=\"2037\">Device master file<\/li><li data-section-id=\"18wnxxx\" data-start=\"2038\" data-end=\"2057\">Plant master file<\/li><li data-section-id=\"qpmuxb\" data-start=\"2058\" data-end=\"2095\"><a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\">Quality management system documents<\/a><\/li><li data-section-id=\"1d8d6of\" data-start=\"2096\" data-end=\"2128\"><a href=\"https:\/\/operonstrategist.com\/buildnext\/plant-layout-detail-engineering\/\">Manufacturing facility details<\/a><\/li><li data-section-id=\"hng28t\" data-start=\"2129\" data-end=\"2169\">Technical specifications of the device<\/li><li data-section-id=\"h0h667\" data-start=\"2170\" data-end=\"2217\">Undertakings and declarations as per MDR 2017<\/li><\/ul>\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<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"What is CDSCO registration for dental medical devices?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"CDSCO registration is the regulatory approval process required for manufacturing, importing, and marketing dental medical devices in India. It ensures that dental devices comply with the safety, quality, and performance requirements defined under the Medical Devices Rules (MDR), 2017.\"}},{\"@type\":\"Question\",\"name\":\"Which dental medical devices fall under Class C and Class D?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Class C and Class D dental medical devices are categorized as moderate to high-risk devices. Examples include dental amalgam, dental amalgam alloy, dental amalgam mercury, transmandibular implants, and medicated reusable dental surgical procedure kits.\"}},{\"@type\":\"Question\",\"name\":\"Is CDSCO licensing mandatory for Class C and Class D dental medical devices?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes. From October 1, 2023, Class C and Class D dental medical devices require a manufacturing or import license under the CDSCO licensing regime as per the latest CDSCO notification.\"}},{\"@type\":\"Question\",\"name\":\"What documents are required for a CDSCO manufacturing license?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The required documents generally include:ISO 13485 certificateDevice master filePlant master fileQuality management system documentsManufacturing facility detailsTechnical specifications of the deviceUndertakings and declarations as per MDR 2017\"}}]}<\/script>\n\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>Dental Medical Device Dental medical devices are tools, instruments, and equipment used by dental professionals to diagnose, treat, and manage various oral health conditions. These devices play a crucial role in maintaining oral hygiene, preventing dental issues, and performing dental procedures effectively.\u00a0 Here are some common types of dental medical devices. The Central Drugs Standard [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6633,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[57],"tags":[],"class_list":["post-6632","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cdsco-category"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/6632","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/comments?post=6632"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/6632\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/media\/6633"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/media?parent=6632"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/categories?post=6632"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/tags?post=6632"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}