{"id":1957,"date":"2025-11-20T17:00:05","date_gmt":"2025-11-20T10:00:05","guid":{"rendered":"https:\/\/mednovum.com.vn\/?post_type=dich_vu&#038;p=1957"},"modified":"2025-11-27T15:42:17","modified_gmt":"2025-11-27T08:42:17","slug":"thu-tu-van-phan-loai-trang-thiet-bi-y-te","status":"publish","type":"dich_vu","link":"https:\/\/mednovum.com.vn\/en\/dich-vu\/thu-tu-van-phan-loai-trang-thiet-bi-y-te\/","title":{"rendered":"Medical Device Classification Advisory Letter"},"content":{"rendered":"<div class=\"vc_row wpb_row vc_row-fluid mpc-row\"><div class=\"wpb_column vc_column_container vc_col-sm-12 mpc-column\" data-column-id=\"mpc_column-1006a49366f758b4\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<h1 class=\"entry-title\" style=\"text-align: center;\"><span style=\"color: #275cab;\"><strong><span style=\"font-size: 24pt;\">QUICK AND ACCURATE MEDICAL EQUIPMENT CLASSIFICATION CONSULTING SERVICE<\/span><\/strong><\/span><\/h1>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">Based on <a href=\"https:\/\/mednovum.com.vn\/nghi-dinh-98-2021-nd-cp-ve-quan-ly-trang-thiet-bi-y-te\/\">Decree 98\/2021\/ND-CP on medical equipment management<\/a> , businesses need to carry out medical equipment classification procedures.<strong>&nbsp;<\/strong>If you want to apply for an import license, declare applicable standards for medical equipment of type A, B, and register a circulation number for medical equipment of type C, D in Vietnam.<\/span><\/p>\n<div data-align=\"justify\" data-pm-slice=\"1 1 []\">\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">Decree 98 was issued with outstanding new points, including changes in the classification of medical equipment, shifting from the classification of medical equipment by an organization licensed to be qualified to classify medical equipment to <strong>Classification of medical equipment will be performed and supervised by the owner of the medical equipment circulation number.<\/strong>Decree 98 takes effect from date <strong>01\/01\/2022<\/strong>.<\/span><\/p>\n<\/div>\n<p style=\"text-align: justify;\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-1379\" src=\"https:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-1.jpg\" alt=\"dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai\" width=\"2048\" height=\"1090\" srcset=\"https:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-1.jpg 2048w, https:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-1-300x160.jpg 300w, https:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-1-1024x545.jpg 1024w, https:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-1-768x409.jpg 768w, https:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-1-1536x818.jpg 1536w, https:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-1-1170x623.jpg 1170w, https:\/\/mednovum.com.vn\/wp-content\/uploads\/2021\/11\/dich-vu-phan-loai-trang-thiet-bi-y-te-8-buoc-1-bang-phan-loai-1-585x311.jpg 585w\" sizes=\"auto, (max-width: 2048px) 100vw, 2048px\" \/><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\"><span class=\"text-color\" style=\"font-family: arial, helvetica, sans-serif;\">This change will certainly cause many difficulties and confusion for businesses in this initial stage. <\/span><span class=\"text-color\" style=\"text-align: justify;\">With&nbsp;<\/span><span style=\"text-align: justify;\">With 5 years of experience in classification and a team of highly specialized lawyers and doctors, MedNovum is proud to be a professional medical equipment classification consulting unit, ready to accompany and support businesses in their difficulties when classifying medical equipment.<\/span><\/span><\/p>\n<h2 style=\"text-align: justify;\"><span style=\"font-size: 18pt;\"><strong>Risks of choosing an unreliable medical equipment classification consulting unit<\/strong><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\"><strong>\u2013 Late progress:<\/strong>&nbsp;The unit does not return the classification consultation results on time as expected, affecting the import and circulation progress.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\"><strong>\u2013 Encountering risks when the Ministry of Health discovers misclassification<\/strong> during post-audit as:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span style=\"font-size: 12pt;\">Affecting the procedure for registration of circulation numbers (for medical equipment of type C, D) or announcement of applicable standards (for medical equipment of type A, B);<\/span><\/li>\n<li><span style=\"font-size: 12pt;\">Affecting the financial security and reputation of the business;<\/span><\/li>\n<li><span style=\"font-size: 12pt;\">Administrative sanctions;<\/span><\/li>\n<li><span style=\"font-size: 12pt;\">Withdrawal of medical equipment declaration\/circulation number;<\/span><\/li>\n<li><span style=\"font-size: 12pt;\">Recall all medical equipment currently in circulation on the market;<\/span><\/li>\n<li><span style=\"font-size: 12pt;\">Re-do the procedure for declaring applicable standards or registering circulation numbers according to new classification.<\/span><\/li>\n<\/ul>\n<h2 style=\"text-align: justify;\"><span style=\"font-size: 18pt;\"><strong>MedNovum \u2013 A reputable and professional medical equipment classification consulting company<\/strong><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">MedNovum is confident that it will be a partner with businesses in successfully approaching the potential medical equipment market in Vietnam. Because:<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 12pt;\"><strong>Team of experts:<\/strong> Our staff are lawyers, doctors, pharmacists with expertise, knowledge of the law, and many years of experience in the field of medical equipment.<\/span><\/li>\n<li style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">All personnel involved in the medical equipment classification process have <strong>Medical Equipment Classification Certificate<\/strong>.<\/span><\/li>\n<li style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">MedNovum acquired <strong>Professional liability insurance<\/strong> for medical equipment classification work from 2019.<\/span><\/li>\n<li><span style=\"font-size: 12pt;\"><strong>Partner of the world&#039;s leading medical equipment companies<\/strong> such as: Medtronic, Fujifilm, Waters Corporation, Delcon SRL, Hans Biomed, Beckman Coulter,...<\/span><\/li>\n<li><span style=\"font-size: 12pt;\">Fast time to return classification consultation results <strong>only 1 \u2013 4 days<\/strong> work<\/span><\/li>\n<li><span style=\"font-size: 12pt;\"><strong>Commitment to accuracy<\/strong> of the classification advice results.<\/span><\/li>\n<li><span style=\"font-size: 12pt;\"><strong>Cost optimization<\/strong> for the following procedures to classify risks by cluster, family, and medical equipment group solutions appropriately according to the business situation of each enterprise<\/span><\/li>\n<li><span style=\"font-size: 12pt;\">Many medical equipment classification consulting service packages with costs suitable to the needs of each business.<\/span><\/li>\n<li><span style=\"font-size: 12pt;\">Consulting, supporting, providing information on legal corridors related to the following procedures after classification: applying for import licenses, declaring standards (for medical equipment of types A, B) or registering circulation numbers (for medical equipment of types C, D)<\/span><\/li>\n<\/ul>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div><div class=\"vc_row wpb_row vc_row-fluid mpc-row\"><div class=\"wpb_column vc_column_container vc_col-sm-12 mpc-column\" data-column-id=\"mpc_column-246a49366f77dfc\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><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=\"tel:+842839111551\" title=\"\"><i class=\"vc_btn3-icon\"><\/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<h2 style=\"text-align: justify;\"><span style=\"font-size: 18pt;\"><strong>What documents do businesses need to prepare to classify medical equipment?<\/strong><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">\u2013 Document requesting consultation on medical equipment classification<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">\u2013 Product catalog (Original product catalog in English);<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">\u2013 Document describing medical equipment technical specifications in Vietnamese according to the form (<a href=\"https:\/\/mednovum.com.vn\/nghi-dinh-36-2016-nd-cp-ve-quan-ly-trang-thiet-bi-y-te\/\">According to the form in Decree 36\/2016\/ND-CP<\/a>);<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">\u2013 ISO 13485: 2016 of medical equipment manufacturing unit<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">\u2013 Certificate of Free Sales (CFS);<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">\u2013 Certified copy of business registration;<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">\u2013 Instructions for use of medical equipment.<\/span><\/p>\n<h2 style=\"text-align: justify;\"><span style=\"font-size: 18pt;\"><strong>Procedure for consulting on medical equipment classification at MedNovum<\/strong><\/span><\/h2>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">MedNovum proceeds through 8 steps with 8 personnel in charge of each stage, ensuring independence and aiming to improve accuracy. MedNovum would like to share the detailed process as follows:<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\"><strong>Step 1: Receiving documents<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">Receive and check documents according to the list of documents required for medical equipment classification.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\"><strong>Step 2: Classification 1<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">Classifier (1) proceeds to read the records and classify them according to regulations.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\"><strong>Step 3: Classification 2<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">Classifier (2) proceeds to read the records and classify them according to regulations. (Classification is independent of Classifier 1)<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\"><strong>Step 4: Fill in the classification consultation form<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">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.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\"><strong>Step 5: Legal check<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">The compliance officer checks the legality of the classification according to the law.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\"><strong>Step 6: Check &amp; sign confirmation of expertise<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">A certified classifier conducts a final inspection and signs the classification.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\"><strong>Step 7: Director approval<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">Attorney\/director proceeds with approval.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\"><strong>Step 8: Send to customer<\/strong><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">After completing the medical equipment classification consultation, MedNovum will send a hard copy to the customer.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">\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>.<\/span><\/p>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div><div class=\"vc_row wpb_row vc_row-fluid mpc-row\"><div class=\"wpb_column vc_column_container vc_col-sm-12 mpc-column\" data-column-id=\"mpc_column-966a49366f7b6fd\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<p><\/p><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-696a49366f79648\"><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\n<p style=\"text-align: center;\"><span style=\"color: #275cab;\"><strong><span style=\"font-size: 24pt;\">Our Customers<\/span><\/strong><\/span><\/p>\n\n\t\t<\/div>\n\t<\/div>\n<div 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center;\"><span style=\"font-family: arial, helvetica, sans-serif; font-size: 24pt; color: #275cab;\"><strong>Contact MedNovum for consultation on procedures and service quotes<\/strong><\/span><\/h3>\n\n\t\t<\/div>\n\t<\/div>\n<\/div><\/div><\/div><\/div><div class=\"vc_row wpb_row vc_row-fluid mpc-row\"><div class=\"wpb_column vc_column_container vc_col-sm-12 mpc-column\" data-column-id=\"mpc_column-866a49366f801ae\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\">\n\t<div class=\"wpb_text_column wpb_content_element\">\n\t\t<div class=\"wpb_wrapper\">\n\t\t\t<div class=\"fluentform ff-default fluentform_wrapper_3 ffs_default_wrap\"><form data-form_id=\"3\" id=\"fluentform_3\" class=\"frm-fluent-form fluent_form_3 ff-el-form-top ff_form_instance_3_1 ff-form-loading ffs_default\" data-form_instance=\"ff_form_instance_3_1\" method=\"POST\" action=\"\"><fieldset style=\"border: none!important;margin: 0!important;padding: 0!important;background-color: 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