{"id":1343,"date":"2024-05-14T14:05:56","date_gmt":"2024-05-14T14:05:56","guid":{"rendered":"https:\/\/derayglobalutama.com\/?p=1343"},"modified":"2025-01-23T10:52:22","modified_gmt":"2025-01-23T03:52:22","slug":"vietnam-mengeluarkan-surat-edaran-tentang-pengelolaan-perangkat-medis","status":"publish","type":"post","link":"https:\/\/derayglobalutama.com\/en\/vietnam-mengeluarkan-surat-edaran-tentang-pengelolaan-perangkat-medis\/","title":{"rendered":"Vietnam Issues a Circular on the Management of Medical Devices"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Regulatory Update: Vietnam Issues a Circular on the Management of Medical Devices<\/h2>\n\n\n\n<p>On August 1, 2022, Vietnam's Ministry of Health issued Circular 05\/2022\/TT-BYT, providing detailed guidance for implementing several provisions of Decree 98\/2021\/ND-CP concerning the management of medical devices. This circular is based on Government Decree No. 75\/2017\/ND-CP and No. 98\/2021\/ND-CP, and it outlines specific regulations as follows:<\/p>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li><strong>In Vitro Diagnostic Medical Equipment:<\/strong>The list of in vitro diagnostic medical devices that are exempt from quality assessment by a competent Vietnamese institution is specified in Point dd Clause 3, Article 30 of Decree No. 98\/2021\/ND-CP. The following conditions apply:\n<ul class=\"wp-block-list\">\n<li>A Free Sales Certificate must be obtained from one of the following authorities:\n<ul class=\"wp-block-list\">\n<li>U.S. Food and Drug Administration (FDA) \u2013 USA<\/li>\n\n\n\n<li>Therapeutic Goods Administration (TGA) \u2013 Australia<\/li>\n\n\n\n<li>Health Canada<\/li>\n\n\n\n<li>Japan\u2019s Ministry of Health, Labor and Welfare (MHLW)<\/li>\n\n\n\n<li>Japan Pharmaceuticals and Medical Devices Agency (PMDA)<\/li>\n\n\n\n<li>China\u2019s National Medical Products Administration (NMPA)<\/li>\n\n\n\n<li>Korean Ministry of Food and Drug Safety (MFDS)<\/li>\n\n\n\n<li>EU Member States, in accordance with Regulation (EU) 2017\/746 on in vitro diagnostic medical devices, issued on April 5, 2017.<br><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li>The device must have a circulation registration certificate or import permit in Vietnam, unless revoked.<\/li>\n\n\n\n<li>The device must not be a reagent, calibrator, or in vitro control material.<br><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Ordinary Commodities<\/strong>:Certain medical devices can be purchased as ordinary commodities without requiring a trade license, provided they meet the standards for preservation, storage, and transit as specified by the device owner. Examples include:\n<ul class=\"wp-block-list\">\n<li>Personal blood pressure monitors<\/li>\n\n\n\n<li>Blood oxygen saturation (SpO2) meters with finger clips<\/li>\n\n\n\n<li>Children's nasal suction machines<\/li>\n\n\n\n<li>Electronic and infrared thermometers<\/li>\n\n\n\n<li>Personal blood glucose measurement devices (e.g., blood glucose meters, collection pens, test strips)<\/li>\n\n\n\n<li>Nebulizers<\/li>\n\n\n\n<li>Bandages and personal medical gauze<\/li>\n\n\n\n<li>Artificial tears classified as medical devices<\/li>\n\n\n\n<li>Condoms and contraceptive films (without drugs)<\/li>\n\n\n\n<li>Vaginal lubrication solutions classified as medical devices<\/li>\n\n\n\n<li>Electric hot and cold packs<\/li>\n\n\n\n<li>In vitro self-test diagnostic equipment classified as Class B<\/li>\n\n\n\n<li>Medical equipment for in vitro self-testing for HIV and SARS-CoV-2<br><\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Safety and Technical Checks<\/strong>: Several medical devices must undergo safety and technical assessments in accordance with Article 10, Article 70 of Presidential Regulation No. 98\/2021\/ND-CP, including:\n<ul class=\"wp-block-list\">\n<li>Anesthesia machines with breathing apparatus<\/li>\n\n\n\n<li>Electric scalpels<\/li>\n\n\n\n<li>Ventilators<\/li>\n\n\n\n<li>Infant incubators<\/li>\n\n\n\n<li>Defibrillators<\/li>\n\n\n\n<li>Hemodialysis machines<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<p>Moreover, many medical devices are granted import permits in compliance with Point D Clause 2 Article 76 of Decree No. 98\/2021\/ND-CP for surgical, diagnostic, dialysis, and other medical applications. <\/p>\n\n\n\n<p>This Circular will come into force on August 1, 2022, following the decision of the Ministry of Health of Vietnam.<\/p>\n\n\n\n<p>Source:&nbsp;<a href=\"https:\/\/luatvietnam.vn\/y-te\/thong-tu-05-2022-tt-byt-bo-y-te-227095-d1.html\" rel=\"noreferrer noopener\" target=\"_blank\">05\/2022\/TT-BYT in Vietnam, Circular 05\/2022\/TT-BYT elaborating Decree 98\/2021\/ND-CP on management of medical devices in Vietnam (thuvienphapluat.vn)<\/a><\/p>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-16018d1d wp-block-buttons-is-layout-flex\" id=\"https:\/\/derayglobalutama.com\/contact-us\/\">\n<div class=\"wp-block-button has-custom-font-size is-style-fill has-medium-font-size\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/derayglobalutama.com\/en\/contact-us\/\" style=\"border-radius:89px;background-color:#a9653c\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Contact Us<\/strong><\/a><\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Pembaruan Regulasi: Vietnam Mengeluarkan Surat Edaran tentang Pengelolaan Alat Kesehatan Pada 1 Agustus 2022, Kementerian Kesehatan Vietnam mengeluarkan Surat Edaran 05\/2022\/TT-BYT, yang memberikan panduan rinci untuk melaksanakan beberapa ketentuan dari Peraturan 98\/2021\/ND-CP mengenai pengelolaan alat kesehatan. Surat edaran ini didasarkan pada Peraturan Pemerintah No. 75\/2017\/ND-CP dan No. 98\/2021\/ND-CP, dan menguraikan regulasi spesifik sebagai berikut: Selain [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2498,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1343","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 4.9.9 - aioseo.com -->\n\t<meta name=\"description\" content=\"Pembaruan Regulasi: Vietnam Mengeluarkan Surat Edaran tentang Pengelolaan Alat Kesehatan Pada 1 Agustus 2022, Kementerian Kesehatan Vietnam mengeluarkan Surat Edaran 05\/2022\/TT-BYT, yang memberikan panduan rinci untuk melaksanakan beberapa ketentuan dari Peraturan 98\/2021\/ND-CP mengenai pengelolaan alat kesehatan. 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