{"id":176,"date":"2018-08-13T11:35:52","date_gmt":"2018-08-13T04:35:52","guid":{"rendered":"https:\/\/mednovum.com.vn\/?page_id=176"},"modified":"2025-10-27T17:21:19","modified_gmt":"2025-10-27T10:21:19","slug":"phan-loai-trang-thiet-bi-y-te","status":"publish","type":"page","link":"http:\/\/mednovum.com.vn\/en\/medical-equipment-classification\/","title":{"rendered":"Classification of Medical Equipment"},"content":{"rendered":"<h2 style=\"text-align: center;\"><strong><span style=\"font-size: 24pt; color: #275cab;\">MEDICAL EQUIPMENT CLASSIFICATION SERVICE<\/span><\/strong><\/h2>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\">Based on <a href=\"http:\/\/mednovum.com.vn\/en\/decree-36-2016-nd-cp-on-medical-equipment-management\/\"><u>Decree 36\/2016\/ND-CP<\/u><\/a>\u00a0on medical equipment management and <a href=\"http:\/\/mednovum.com.vn\/en\/decree-no-169-2018-nd-cp-dated-december-31-2018-amending-and-supplementing-a-number-of-articles-of-decree-no-36-2016-nd-cp-of-the-government-on-medical-equipment-management\/\"><u>Decree No. 169\/2018\/ND-CP<\/u><\/a>, <a href=\"http:\/\/mednovum.com.vn\/en\/decree-03-2020-nd-cp-dated-january-1-2020-amending-article-68-of-decree-36-2016-nd-cp-on-medical-equipment-management-was-amended-in-decree-169-2018-nd-cp-amending-decree-36-2016-nd-cp-on-medical-equ\/\"><u>Decree No. 03\/2020\/ND-CP<\/u><\/a>\u00a0Amending and supplementing a number of articles of <a href=\"http:\/\/mednovum.com.vn\/en\/decree-36-2016-nd-cp-on-medical-equipment-management\/\"><u>Decree 36\/2016\/ND-CP<\/u><\/a>, businesses need to carry out medical equipment classification procedures.<strong><b>\u00a0<\/b><\/strong>If you want to apply for an import license, declare applicable standards for medical equipment of type A, register a circulation number for medical equipment of type B, C, D in Vietnam.<\/p>\n<p style=\"text-align: justify;\"><strong><b>The results of this risk classification are only recognized when performed by a licensed entity qualified to classify medical devices (MTDs).<\/b><\/strong><\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><img decoding=\"async\" class=\"aligncenter size-full wp-image-1313\" src=\"http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai.jpg\" alt=\"medical equipment classification service 8 steps 1 classification table\" width=\"2048\" height=\"1090\" srcset=\"http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai.jpg 2048w, http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-300x160.jpg 300w, http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-1024x545.jpg 1024w, http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-768x409.jpg 768w, http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-1536x818.jpg 1536w, http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-1170x623.jpg 1170w, http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-585x311.jpg 585w\" sizes=\"(max-width: 2048px) 100vw, 2048px\" \/><\/h2>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: justify;\"><strong><b>Risks of choosing an unreliable medical equipment classification unit<\/b><\/strong><\/h2>\n<p style=\"text-align: justify;\"><strong><b>\u2013 Late progress:<\/b><\/strong>\u00a0The unit does not return the classification results on time as expected, affecting the progress of import and circulation.<\/p>\n<p style=\"text-align: justify;\"><strong><b>\u2013 Encountering risks when the Ministry of Health discovers misclassification<\/b><\/strong>\u00a0during post-audit as:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Impact on procedures for applying for import license and circulation number (for medical equipment of type B, C, D) or announcement of applicable standards (for medical equipment of type A)<\/li>\n<li>Impact on financial security and reputation of the business<\/li>\n<li>Administrative sanctions<\/li>\n<li>Withdrawal of medical equipment declaration\/circulation number<\/li>\n<li>Recall all medical equipment in circulation on the market<\/li>\n<li>Re-do the procedure of declaring applicable standards or registering circulation numbers according to new classification<\/li>\n<\/ul>\n<h2 style=\"text-align: justify;\"><strong><b>MedNovum \u2013 A reputable medical equipment classification company, licensed by the Ministry of Health<\/b><\/strong><\/h2>\n<p style=\"text-align: justify;\">MedNovum is a licensed entity qualified to classify medical equipment. MedNovum is confident that it will be a partner to accompany businesses in successfully accessing the potential medical equipment market in Vietnam. Because:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Our staff are lawyers, doctors, pharmacists with expertise, knowledge of the law, and many years of experience in the field of medical equipment.<\/li>\n<li>Partner of the world&#039;s leading medical equipment companies such as: Emergo, Medtronic, Fujifilm,...<\/li>\n<li>Fast sorting time <strong>only 1 \u2013 4 business days<\/strong>.<\/li>\n<li>Commitment to the accuracy of classification results.<\/li>\n<li>Optimize costs for post-risk classification procedures using cluster, family, and medical equipment group solutions appropriately according to the business situation of each enterprise.<\/li>\n<li>Many medical equipment classification service packages with costs suitable to the needs of each business.<\/li>\n<li>Consulting, supporting, providing information on legal corridors related to post-classification procedures: applying for import licenses, declaring standards (for medical equipment with type A medical equipment) or registering circulation numbers (for medical equipment with types B, C, D).<\/li>\n<\/ul>\n<h2 style=\"text-align: justify;\"><strong><b>What documents do businesses need to prepare to classify medical equipment?<\/b><\/strong><\/h2>\n<p style=\"text-align: justify;\">\u2013 Document requesting to issue a medical equipment classification certificate;<\/p>\n<p style=\"text-align: justify;\">\u2013 Product catalog (Original product catalog in English);<\/p>\n<p style=\"text-align: justify;\">\u2013 Document describing medical equipment technical specifications in Vietnamese according to the form (<a href=\"http:\/\/mednovum.com.vn\/en\/decree-36-2016-nd-cp-on-medical-equipment-management\/\"><u>According to the form in Decree 36\/2016\/ND-CP<\/u><\/a>);<\/p>\n<p style=\"text-align: justify;\">\u2013 ISO 13485: 2016 of medical equipment manufacturing unit;<\/p>\n<p style=\"text-align: justify;\">\u2013 Certificate of Free Sales (CFS);<\/p>\n<p style=\"text-align: justify;\">\u2013 Certified copy of business registration;<\/p>\n<p style=\"text-align: justify;\">\u2013 Instructions for use of medical equipment.<\/p>\n<h2 style=\"text-align: justify;\"><strong><b>Procedure for classifying medical equipment at MedNovum<\/b><\/strong><\/h2>\n<p style=\"text-align: justify;\">MedNovum proceeds through <strong>8 steps with 8 staff in charge of each stage<\/strong>, ensuring independence and aiming to improve accuracy. MedNovum would like to share the detailed process as follows:<\/p>\n<p style=\"text-align: justify;\"><strong>Step 1: Receiving documents<\/strong><\/p>\n<p style=\"text-align: justify;\">Receive and check documents according to the list of documents required for classification of Medical Equipment.<\/p>\n<p style=\"text-align: justify;\"><strong>Step 2: Classification 1<\/strong><\/p>\n<p style=\"text-align: justify;\">Classifier (1) proceeds to read the records and classify them according to regulations.<\/p>\n<p style=\"text-align: justify;\"><strong>Step 3: Classification 2<\/strong><\/p>\n<p style=\"text-align: justify;\">Classifier (2) proceeds to read the records and classify them according to regulations. (Classification is independent of classifier 1).<\/p>\n<p style=\"text-align: justify;\"><strong>Step 4: Create a classification form<\/strong><\/p>\n<p style=\"text-align: justify;\">Conduct product name\/model\/code checks according to customer requirements and conduct draft classification based on the consensus results of the previous 2 classification specialists.<\/p>\n<p style=\"text-align: justify;\"><strong>Step 5: Legal check<\/strong><\/p>\n<p style=\"text-align: justify;\">The compliance officer checks the legality of the classification according to the law.<\/p>\n<p style=\"text-align: justify;\"><strong>Step 6: Check &amp; Sign Confirmation of Expertise<\/strong><\/p>\n<p style=\"text-align: justify;\">A certified classifier conducts a final inspection and signs the classification.<\/p>\n<p style=\"text-align: justify;\"><strong>Step 7: Director approval <\/strong><\/p>\n<p style=\"text-align: justify;\">Attorney\/director proceeds with approval.<\/p>\n<p style=\"text-align: justify;\"><strong>Step 8: Publish results &amp; Send to customers<\/strong><\/p>\n<p style=\"text-align: justify;\">Publish the results of medical equipment classification and records on the Ministry of Health&#039;s Information Portal. Send hard copies to customers.<\/p>\n<p>&nbsp;<\/p>\n<p>\u2666 Customers can use the service <strong>fast<\/strong> <strong>Premium<\/strong> return results within <strong>1 \u2013 4 working days<\/strong> or<strong> Slow Basic<\/strong> return results within <strong>5 \u2013 7 working days<\/strong>.<\/p>\n<p>&nbsp;<\/p>\n<div class=\"vc_btn3-container vc_btn3-center\" ><a class=\"vc_general vc_btn3 vc_btn3-size-lg vc_btn3-shape-rounded vc_btn3-style-modern vc_btn3-icon-left vc_btn3-color-warning\" href=\"http:\/\/tel\" title=\"\"><i class=\"vc_btn3-icon fa fa-phone\"><\/i> <strong>CALL NOW FOR CONSULTATION: +84 28 3911 1551<\/strong><\/a><\/div>\n\t<div class=\"wpb_text_column wpb_content_element\" >\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\">Above is detailed information about MedNovum&#039;s medical equipment classification process. In addition:<\/p>\n<p style=\"text-align: justify;\">\u2611\ufe0f All personnel involved in the medical equipment classification process have <strong>Medical Equipment Classification Certificate<\/strong>.<\/p>\n<p style=\"text-align: justify;\">\u2611\ufe0f MedNovum purchased <strong>Professional liability insurance<\/strong> for medical equipment classification work from 2019.<\/p>\n<p style=\"text-align: justify;\">If you have any questions or need medical equipment legal services, please call MedNovum via hotline<span style=\"color: #ff0000; font-size: 14pt;\"><strong> +84 <b>28 3911 1551<\/b><\/strong><\/span><strong><b>,<\/b><\/strong>\u00a0We will contact you within 24 hours to answer your questions and provide free consultation.<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: center;\"><span style=\"color: #044394;\"><strong><span style=\"font-size: 24pt;\">Our Customers<\/span><\/strong><\/span><\/p>\n<div class=\"mpc-carousel__wrapper mpc-waypoint\"><div id=\"mpc_carousel_slider-3769f2868af05e2\" class=\"mpc-carousel-slider mpc-init mpc-effect--none\"  data-mpcslick='{\"infinite\":true,\"autoplay\":true,\"slidesToShow\":3,\"slidesToScroll\":1,\"centerMode\":false,\"initialSlide\":0,\"autoplaySpeed\":500,\"variableWidth\":true,\"rows\":1}' data-slick-cols=\"3\"><div onclick=\"\" class=\"mpc-carousel__item-wrapper\"><div class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"86\" src=\"http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/Emergo-logo-mednovums-client-300x86.png\" class=\"mpc-transition attachment-medium\" alt=\"Emergo-logo-mednovum&#039;s-client\" srcset=\"http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/Emergo-logo-mednovums-client-300x86.png 300w, http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/Emergo-logo-mednovums-client.png 454w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div onclick=\"\" 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http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/10\/5-fujifilm-logo-1-585x329.jpg 585w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><div onclick=\"\" class=\"mpc-carousel__item-wrapper\"><div class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"259\" height=\"125\" src=\"http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/10\/Stryker.png\" class=\"mpc-transition attachment-medium\" alt=\"stryker-logo-mednovum&#039;s-client\" \/><\/div><\/div><div onclick=\"\" class=\"mpc-carousel__item-wrapper\"><div class=\"mpc-item mpc-transition\"><div class=\"mpc-border\"><\/div><img decoding=\"async\" width=\"300\" height=\"162\" src=\"http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/10\/zimmer-300x162.jpg\" class=\"mpc-transition attachment-medium\" alt=\"zimmer-logo-mednovum&#039;s-client\" srcset=\"http:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/10\/zimmer-300x162.jpg 300w, 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class=\"mpc-nav__background mpc-transition mpc-effect-type--fade mpc-effect-side--in\"><\/div><\/i><\/div><\/div><\/div><\/div>\n<p>&nbsp;<\/p>\n<h3 style=\"text-align: center;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 24pt; color: #044394;\"><strong>Contact MedNovum for consultation on procedures and service quotes<\/strong><\/span><\/h3>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><div class=\"vc_row wpb_row vc_row-fluid mpc-row\"><\/div><div class=\"wpb_column vc_column_container vc_col-sm-12 mpc-column\" data-column-id=\"mpc_column-6869f2868b036b8\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div>\n\t<div class=\"wpb_text_column wpb_content_element\" >\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t\n\t\t<\/div>\n\t<\/div>\n[super_form id=\u201d121\u2033]<\/p>\n\n\t\t<\/div>\n\t<\/div>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\">&gt;&gt; <span style=\"font-size: 12pt;\"><strong><b>See more legal services at MedNovum<\/b><\/strong><\/span>:<\/p>\n<p style=\"text-align: justify;\">&#8211; <a href=\"https:\/\/mednovum.com.vn\/en\/dang-ky-luu-hanh-trang-thiet-bi-y-te\/\"><u>Registering medical equipment circulation number<\/u><\/a><\/p>\n<p style=\"text-align: justify;\">&#8211; <a href=\"https:\/\/mednovum.com.vn\/en\/xin-giay-phep-nhap-khau-trang-thiet-bi\u0323-y-te\/\"><u>Apply for a license to import medical equipment<\/u><\/a><\/p>\n<p style=\"text-align: justify;\">&#8211; <a href=\"https:\/\/mednovum.com.vn\/en\/cong-bo-du-dieu-kien-mua-ban-san-xuat-trang-thiet-bi-y-te\/\"><u>Announcement of eligibility to buy, sell and produce medical equipment<\/u><\/a><\/p>\n<p><a href=\"https:\/\/mednovum.com.vn\/en\/dich-thuat-bien-soan-tai-lieu-ky-thuat-huong-dan-su-dung\/\">\u2013 Translation and compilation of technical documents on instructions for using medical equipment<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>D\u1ecaCH V\u1ee4 PH\u00c2N LO\u1ea0I TRANG THI\u1ebeT B\u1eca Y T\u1ebe &nbsp; C\u0103n c\u1ee9 theo Ngh\u1ecb \u0111\u1ecbnh 36\/2016\/N\u0110-CP\u00a0v\u1ec1 qu\u1ea3n l\u00fd trang thi\u1ebft b\u1ecb y t\u1ebf v\u00e0 Ngh\u1ecb \u0111\u1ecbnh s\u1ed1 169\/2018\/N\u0110-CP, Ngh\u1ecb \u0111\u1ecbnh<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-176","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/pages\/176","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/comments?post=176"}],"version-history":[{"count":0,"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/pages\/176\/revisions"}],"wp:attachment":[{"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/media?parent=176"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}