{"id":262,"date":"2026-01-09T03:51:24","date_gmt":"2026-01-09T03:51:24","guid":{"rendered":"https:\/\/yiyong3d.ui-project.com\/?page_id=262"},"modified":"2026-01-23T07:26:08","modified_gmt":"2026-01-23T07:26:08","slug":"registration-service","status":"publish","type":"page","link":"https:\/\/addylon.com\/ar\/solution\/registration-service-class\/registration-service\/","title":{"rendered":"\u062e\u062f\u0645\u0629 \u0627\u0644\u062a\u0633\u062c\u064a\u0644"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"262\" class=\"elementor elementor-262\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc1cf9e e-flex e-con-boxed e-con e-parent\" data-id=\"dc1cf9e\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1edf599 e-flex e-con-boxed e-con e-parent\" data-id=\"1edf599\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-2c40667 e-con-full e-flex e-con e-child\" data-id=\"2c40667\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fd793d9 elementor-widget elementor-widget-heading\" data-id=\"fd793d9\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u062e\u062f\u0645\u0629 \u0627\u0644\u062a\u0633\u062c\u064a\u0644<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4023252 e-con-full e-flex e-con e-child\" data-id=\"4023252\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fbc2fc elementor-widget elementor-widget-text-editor\" data-id=\"5fbc2fc\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong>Registration Requirements for Domestic Class II and III Medical Devices:<\/strong><\/p><p>Required information:<\/p><p>1. Application form<\/p><p>2. Supporting documents<\/p><p>3. List of basic requirements for the safety and effectiveness of medical devices<\/p><p>4. Overview documents<\/p><p>5. Research\u00a0documents<\/p><p>6. Manufacturing documents<\/p><p>7. Clinical evaluation documents<\/p><p>8. Product registration test report<\/p><p>9. Product technical requirements<\/p><p>10. Product registration test report<\/p><p>11. Sample instructions and labels<\/p><p>12. Declaration of conformity<\/p><p>\u00a0<\/p><p><strong>Specific contents:<\/strong><\/p><p>4.1 Overview<\/p><p>4.2 Product description<\/p><p>4.3 Model specifications<\/p><p>4.4 Packaging instructions<\/p><p>4.5 Scope of application and contraindications<\/p><p>4.6 Information on reference to similar\/preceding products<\/p><p>4.7 Other elements to be described<\/p><p>5.1 Product performance studies<\/p><p>5.2 Bio-compatibility evaluation study<\/p><p>5.3 Bio-safety studies<\/p><p>5.4 Sterilization and disinfection process studies<\/p><p>5.5 Efficacy and packaging studies<\/p><p>5.6 Animal studies<\/p><p>5.7 Software studies<\/p><p>5.8 Other<\/p><p>6.1 Description of passive\/active product production process information<\/p><p>6.2 Production sites<\/p><p>10.1 Registration inspection reports<\/p><p>10.2 Pre-evaluation comments<\/p><p>11.1 Instruction manual<\/p><p>11.2 Sample label for the smallest sales unit<\/p><p><strong>Registration processes\u00a0of Class II and III Domestic Medical Device:<\/strong><\/p><p><img decoding=\"async\" class=\"aligncenter\" title=\"\u062e\u062f\u0645\u0629 \u0627\u0644\u062a\u0633\u062c\u064a\u0644\" src=\"https:\/\/0.rc.xiniu.com\/g4\/M00\/75\/03\/CgAG0mPHbCmASQY3AAFLIhyWORk407.png\" alt=\"Registration service\" width=\"930\" border=\"0\" vspace=\"0\" \/><\/p>\t\t\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>","protected":false},"excerpt":{"rendered":"<p>Registration service Registration Requirements for Domestic Class II and III Medical Devices: Required information: 1. Application form 2. Supporting documents 3. List of basic requirements for the safety and effectiveness of medical devices 4. Overview documents 5. Research\u00a0documents 6. Manufacturing documents 7. Clinical evaluation documents 8. Product registration test report 9. Product technical requirements 10. [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"parent":407,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-262","page","type-page","status-publish","hentry"],"_hostinger_reach_plugin_has_subscription_block":false,"_hostinger_reach_plugin_is_elementor":false,"_links":{"self":[{"href":"https:\/\/addylon.com\/ar\/wp-json\/wp\/v2\/pages\/262","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/addylon.com\/ar\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/addylon.com\/ar\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/addylon.com\/ar\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/addylon.com\/ar\/wp-json\/wp\/v2\/comments?post=262"}],"version-history":[{"count":16,"href":"https:\/\/addylon.com\/ar\/wp-json\/wp\/v2\/pages\/262\/revisions"}],"predecessor-version":[{"id":819,"href":"https:\/\/addylon.com\/ar\/wp-json\/wp\/v2\/pages\/262\/revisions\/819"}],"up":[{"embeddable":true,"href":"https:\/\/addylon.com\/ar\/wp-json\/wp\/v2\/pages\/407"}],"wp:attachment":[{"href":"https:\/\/addylon.com\/ar\/wp-json\/wp\/v2\/media?parent=262"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}