{"id":1875,"date":"2024-09-14T05:51:06","date_gmt":"2024-09-14T05:51:06","guid":{"rendered":"https:\/\/derayglobalutama.com\/?page_id=1875"},"modified":"2024-12-28T08:40:02","modified_gmt":"2024-12-28T01:40:02","slug":"pengawasan-pasca-pemasaran","status":"publish","type":"page","link":"https:\/\/derayglobalutama.com\/en\/pengawasan-pasca-pemasaran\/","title":{"rendered":"Post-Marketing Surveillance"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"1875\" class=\"elementor elementor-1875\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bad1f7f e-flex e-con-boxed e-con e-parent\" data-id=\"bad1f7f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;,&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-041a3b7 e-flex e-con-boxed e-con e-child\" data-id=\"041a3b7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-09e2116 elementor-widget elementor-widget-heading\" data-id=\"09e2116\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Post-Marketing Surveillance\n<\/h2>\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-2d588c4 e-flex e-con-boxed e-con e-child\" data-id=\"2d588c4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6c5ea29 e-con-full e-flex e-con e-child\" data-id=\"6c5ea29\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ffae857 elementor-widget elementor-widget-text-editor\" data-id=\"ffae857\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Medical device manufacturers and locally appointed dealers (aka economic operators) are required to conduct Post-Market Surveillance (PMS) to ensure quality and evaluate the safety, performance, and effectiveness of medical devices.<\/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-d7b9128 e-flex e-con-boxed e-con e-child\" data-id=\"d7b9128\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div 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e-parent\" data-id=\"e8dd1ff\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f77e0ef elementor-widget elementor-widget-spacer\" data-id=\"f77e0ef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\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<div class=\"elementor-element elementor-element-5ff598f e-flex e-con-boxed e-con e-parent\" data-id=\"5ff598f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6afe13c e-con-full e-flex e-con e-child\" data-id=\"6afe13c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fae6339 elementor-widget elementor-widget-heading\" data-id=\"fae6339\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Our Services<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb1550b eael_simple_menu_hamburger_disable_selected_menu_no eael-simple-menu-hamburger-align-right eael-hamburger--tablet elementor-widget elementor-widget-eael-simple-menu\" data-id=\"cb1550b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"eael-simple-menu.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>\n                        @media screen 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1024px)&quot;,&quot;desktop&quot;:&quot;Desktop (&gt; 2400px)&quot;,&quot;none&quot;:&quot;None&quot;}\" data-hamburger-device=\"tablet\">\n                <ul id=\"menu-all-layanan\" class=\"eael-simple-menu eael-simple-menu-dropdown-animate-to-top eael-simple-menu-indicator eael-simple-menu-vertical\"><li id=\"menu-item-2708\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-2708\"><a href=\"https:\/\/derayglobalutama.com\/en\/perwakilan_lisensi\/\">License Representative<\/a><\/li>\n<li id=\"menu-item-1966\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-1966\"><a href=\"https:\/\/derayglobalutama.com\/en\/reg-produk\/\">Product Registration<\/a><\/li>\n<li id=\"menu-item-1958\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-1958\"><a href=\"https:\/\/derayglobalutama.com\/en\/layanan-pendirian-pt-alat-kesehatan\/\">Medical Device Company Establishment Service<\/a><\/li>\n<li id=\"menu-item-1965\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-1965\"><a href=\"https:\/\/derayglobalutama.com\/en\/perpanjangan-dan-perubahan-izin-edar-draft\/\">Renewal and License Amendment<\/a><\/li>\n<li id=\"menu-item-1964\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-1964\"><a href=\"https:\/\/derayglobalutama.com\/en\/sertifikat-lain-lain-draft\/\">Miscellaneous Certificates<\/a><\/li>\n<li id=\"menu-item-1957\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-1957\"><a href=\"https:\/\/derayglobalutama.com\/en\/pengawasan-pasca-pemasaran\/\">Post-Marketing Surveillance<\/a><\/li>\n<li id=\"menu-item-1961\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-1961\"><a href=\"https:\/\/derayglobalutama.com\/en\/e-katalog\/\">E- Catalogue<\/a><\/li>\n<li id=\"menu-item-1963\" class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-1963\"><a 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Menu<\/span>\n                    <svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-bars\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M16 132h416c8.837 0 16-7.163 16-16V76c0-8.837-7.163-16-16-16H16C7.163 60 0 67.163 0 76v40c0 8.837 7.163 16 16 16zm0 160h416c8.837 0 16-7.163 16-16v-40c0-8.837-7.163-16-16-16H16c-8.837 0-16 7.163-16 16v40c0 8.837 7.163 16 16 16zm0 160h416c8.837 0 16-7.163 16-16v-40c0-8.837-7.163-16-16-16H16c-8.837 0-16 7.163-16 16v40c0 8.837 7.163 16 16 16z\"><\/path><\/svg>                <\/button>\n            <\/div>\n            \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e9e8b3b e-con-full e-flex e-con e-child\" data-id=\"e9e8b3b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2cf1841 elementor-widget elementor-widget-text-editor\" data-id=\"2cf1841\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Post-Marketing Surveillance<br><\/strong><br>Indonesia Post Market Control Regulation<br>Regulation No. 36\/2009:<br>Article 196: Every person who intentionally produces or distributes pharmaceutical preparations and \/ or medical devices that do not meet the standards and \/ or security requirements, efficacy or benefits, and quality is punished with a maximum of 10 (ten) years imprisonment and a maximum fine of Rp.1,000,000,000 (one billion Rupiah).<\/p>\n<p>Article 197: Every person who intentionally produces or distributes pharmaceutical preparations and \/ or medical devices that do not have product approval \/ marketing license \/ AKL \/ AKD as referred to in Article 106 paragraph (1) shall be punished with a maximum of 15 (fifteen) years imprisonment and a maximum fine of Rp1,500,000,000 , 00 (one billion five hundred million rupiah).<\/p>\n<p>Article 98 Point 3: Regarding procurement, storage, processing, promotion, distribution of pharmaceutical product and medical devices should be meet with service quality standards which stipulated by government regulations.<\/p>\n<p><strong>Production and Distribution Facilities Control<\/strong><\/p>\n<p><strong>E-Report<br><\/strong><br>is an application built to facilitate public services in the process of reporting of medical device manufacturers as well as reporting the result of distribution (distributor) by medical device dealer.<\/p>\n<p>This system is a control of the possibility of using illegal medical devices that contain information on products which has produced and distributed by the manufacturers to local distributors before the products reached in the end users. Some of information that can be find through E-Report system include: Manufacturing license information (for local manufacturer), Distribution license information (for local distributors), Sales channel partner information, Lot \/ Batch product information, and product serial number. This information should be provided by local manufacturer or distributor before their release the product to the end users or sale channel partner.<\/p>\n<p><strong>Post Market Surveillance<br><\/strong><br>Post market surveillance is carried out by the government in order to check the suitability of the quality, safety, and performance of the equipment during distribution and the conformity assessment of the data which was submitted during product registration. To control this program, the government carries out periodically through monitoring of manufacturer \/ distributor facilities, Quality system audit, products sampling in the market.<\/p>\n<p><strong>Our Services:<br><\/strong><br>Electronic Reporting (E-Report)<br>Product Complaint and Recall<br>Field Safety Corrective Action (FSCA)<\/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-6029114 e-flex e-con-boxed e-con e-child\" data-id=\"6029114\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-93aaebb e-con-full e-flex e-con e-child\" data-id=\"93aaebb\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8bd006f elementor-widget elementor-widget-heading\" data-id=\"8bd006f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Get a quote to register medical devices in Indonesia<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5992e88 e-flex e-con-boxed e-con e-child\" data-id=\"5992e88\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<a class=\"eael-wrapper-link-6bd8077 --eael-wrapper-link-tag\" href=\"https:\/\/derayglobalutama.com\/en\/contact-us\/\" target=\"_blank\"><\/a>\t\t<div data-eael-wrapper-link=\"eael-wrapper-link-6bd8077\" class=\"elementor-element elementor-element-6bd8077 elementor-widget__width-auto elementor-align-right elementor-widget elementor-widget-button\" data-id=\"6bd8077\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/derayglobalutama.com\/en\/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\">Get a Quotes<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d7a0c1 elementor-widget elementor-widget-menu-anchor\" data-id=\"3d7a0c1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"quote\"><\/div>\n\t\t\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-f43406a e-flex e-con-boxed e-con e-parent\" data-id=\"f43406a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b0e5cfb elementor-widget elementor-widget-spacer\" data-id=\"b0e5cfb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\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>","protected":false},"excerpt":{"rendered":"<p>Pengawasan Pasca Pemasaran Produsen alat kesehatan dan dealer yang ditunjuk secara lokal (alias operator ekonomi) diwajibkan untuk melakukan Post-Market Surveillance (PMS) untuk memastikan kualitas dan mengevaluasi keamanan, kinerja, dan efektivitas alat kesehatan. Get a Quote Layanan Lainnya Registrasi Produk Layanan Pendirian PT Alat Kesehatan Perpanjangan &amp; Perubahan Izin Edar Sertifikat Lain-Lain Pengawasan Pasca Pemasaran Pengurusan [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-1875","page","type-page","status-publish","hentry"],"aioseo_notices":[],"rttpg_featured_image_url":null,"rttpg_author":{"display_name":"admin web","author_link":"https:\/\/derayglobalutama.com\/en\/author\/admin-web\/"},"rttpg_comment":0,"rttpg_category":null,"rttpg_excerpt":"Pengawasan Pasca Pemasaran Produsen alat kesehatan dan dealer yang ditunjuk secara lokal (alias operator ekonomi) diwajibkan untuk melakukan Post-Market Surveillance (PMS) untuk memastikan kualitas dan mengevaluasi keamanan, kinerja, dan efektivitas alat kesehatan. 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