{"id":2224,"date":"2026-03-22T15:33:42","date_gmt":"2026-03-22T08:33:42","guid":{"rendered":"https:\/\/mednovum.com.vn\/?post_type=dich_vu&#038;p=2224"},"modified":"2026-04-10T11:09:04","modified_gmt":"2026-04-10T04:09:04","slug":"dang-ky-thuc-pham-chuc-nang-buoc-di-chien-luoc-khi-tham-nhap-vao-thi-truong-viet-nam","status":"publish","type":"dich_vu","link":"http:\/\/mednovum.com.vn\/en\/dich-vu\/dang-ky-thuc-pham-chuc-nang-buoc-di-chien-luoc-khi-tham-nhap-vao-thi-truong-viet-nam\/","title":{"rendered":"Dietary supplement registration \u2013 A strategic step when entering the Vietnamese market"},"content":{"rendered":"<p style=\"text-align: center;\"><span style=\"font-size: 24pt;\"><strong><span style=\"color: #3366ff;\">DIETARY SUPPLEMENT REGISTRATION \u2013 A STRATEGIC STEP WHEN ENTERING THE VIETNAMESE MARKET<\/span><\/strong><\/span><\/p>\n<p style=\"text-align: justify;\">In recent years, Vietnam has emerged as one of the fastest-growing markets for dietary supplements and nutritional products in Southeast Asia. This development is driven by consumers\u2019 increasing awareness of the principle that \u201cprevention is better than cure,\u201d leading to a growing preference for proactive health care solutions. Thereby, demand for products such as vitamins, probiotics, collagen, and herbal-based products is increasing significantly. At the same time, over the past decade, the market has recorded impressive growth, supported by the expansion of the middle class and increasing health awareness. Notably, Vietnamese consumers tend to place trust in imported products, creating favorable conditions for international brands from the United States, Canada, Europe, Japan, and South Korea to expand their presence in this market.<\/p>\n<p style=\"text-align: justify;\">However, alongside this growth potential, the regulatory framework is becoming increasingly stringent. Before being circulated, dietary supplements are required to carry out the product declaration registration procedure in accordance with food safety regulations. Therefore, preparing a complete, accurate, and compliant dossier from the beginning not only helps enterprises shorten the time to market entry but also plays an important role in ensuring compliance and maintaining stable business operations in Vietnam.<\/p>\n<p style=\"text-align: justify;\"><strong>Common challenges faced by enterprises when registering dietary supplements in Vietnam <\/strong><\/p>\n<p style=\"text-align: justify;\">Entering the Vietnamese market is not only a matter of the product itself but also a matter of legal strategy and the ability to implement it correctly from the beginning. Enterprises with well-prepared strategies not only shorten the registration timeline but also establish a solid foundation for long-term development. In practice, many products with significant potential still encounter difficulties during the registration process due to insufficient understanding of the regulations, inadequate dossier preparation, or incorrect assessment of the applicable legal framework. These issues not only prolong market entry but also increase costs and directly affect business plans. Below are the challenges that enterprises should pay particular attention to:<\/p>\n<p style=\"text-align: justify;\"><strong><em>First, classification and identification of the correct legal framework.<\/em><\/strong> The boundary between dietary supplements, conventional foods, and pharmaceuticals is not always clearly defined in certain cases. This is one of the first challenges that enterprises must face. Determining whether a product falls under Dietary Supplement, Health Supplement, Functional Food, or Medical Food is crucial for the entire registration pathway. In Vietnam, most nutraceutical products are regulated as Health Supplements.<\/p>\n<p style=\"text-align: justify;\">If the classification is inaccurate, enterprises may apply incorrect regulations, resulting in requests for dossier supplementation or adjustment, or even rejection, thereby prolonging the time required to bring the product to market.<\/p>\n<p style=\"text-align: justify;\"><em><strong>Second, selecting an appropriate legal entity in Vietnam.<\/strong><\/em> For foreign enterprises, the absence of a legal entity in Vietnam is one of the common barriers. Under current regulations, the product registration dossier must be submitted by a legal entity legally established in Vietnam. This requires enterprises to consider options such as establishing a subsidiary, cooperating with an importer, or appointing an entity to stand in the name of the product circulation license. Each option has its own advantages and disadvantages and directly affects product control, financial optimization, market strategy, and long-term legal risks.<\/p>\n<p style=\"text-align: justify;\"><strong><em>Third, increasingly stringent scientific dossier and technical documentation requirements.<\/em><\/strong><strong><em>\u00a0<\/em><\/strong>Regulatory authorities increasingly require clear scientific evidence supporting product claims, particularly for products that make health support claims. In addition, enterprises must prepare necessary documents such as:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Certificate of Free Sale (CFS)<\/li>\n<li>GMP Certificate of the manufacturing facility<\/li>\n<li>Ingredient formulation and raw material technical specifications<\/li>\n<li>Test report or Certificate of Analysis (CoA)<\/li>\n<li>Product label compliant with Vietnamese regulations<\/li>\n<li>Scientific documents supporting the product\u2019s claimed functions<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">All documents must be translated into Vietnamese, and in many cases must be consular legalized or notarized in accordance with regulations.<\/p>\n<p style=\"text-align: justify;\"><strong><em>Fourth, stricter control over ingredients and active substance levels.<\/em><\/strong><strong><em>\u00a0<\/em><\/strong>Ingredients used in dietary supplements are increasingly subject to strict control regarding origin, usage levels, and safety. If a product contains uncommon ingredients, exceeds recommended thresholds, or lacks sufficient safety data, the dossier review process may be prolonged or rejected. During circulation on the market after importation, products are also required to undergo periodic testing in Vietnam to monitor and confirm compliance with safety and quality indicators such as microbiological limits, heavy metals, and active ingredient content. Testing must be conducted by laboratories recognized by the competent authorities.<\/p>\n<p style=\"text-align: justify;\"><strong><em>Fifth, stricter requirements for labeling and advertising content.<\/em><\/strong><strong><em>\u00a0<\/em><\/strong>Current regulations place particular emphasis on controlling information presented on labels and in advertising materials in order to avoid dietary supplements being misunderstood as medicinal products. Enterprises must ensure that descriptions of product functions comply with regulations and avoid misleading claims or statements exceeding the permitted scope. In addition, the Law amending and supplementing several articles of the Law on Advertising was adopted by the National Assembly on June 16, 2025 and took effect on January 01, 2026. This law introduces stricter regulations on advertising forms, particularly online advertising, the activities of KOLs\/KOCs, and cross-border platforms, while also clarifying the responsibilities of organizations and individuals participating in advertising and product business activities.<\/p>\n<p style=\"text-align: justify;\"><strong><em>Finally, strengthening post-market surveillance and enterprise responsibilities. <\/em><\/strong>Even when the product declaration dossier has been accepted, it does not mean that legal obligations have been fully completed. Products after being circulated on the market remain subject to strict supervision by regulatory authorities. If discrepancies in ingredients, quality, or declared information are discovered, enterprises may face enforcement measures such as product recall, administrative penalties, or suspension of circulation.<\/p>\n<p style=\"text-align: justify;\"><strong>MedNovum \u2013 A strategic legal partner that helps you not only \u201cregister successfully\u201d but also \u201coperate successfully.\u201d<\/strong><\/p>\n<p style=\"text-align: justify;\">With a multidisciplinary team of experts, we help enterprises minimize legal risks, optimize resources, and accelerate market entry. MedNovum not only provides registration services but also acts as a <strong>strategic legal partner<\/strong>, accompanying enterprises throughout the entire process of bringing products into the Vietnamese market. We understand that an approved dossier is only the beginning. What enterprises truly need is a solution that helps:<\/p>\n<ul style=\"text-align: justify;\">\n<li>Accurately assess your eligibility to apply from the start<\/li>\n<li>Build dossiers aligned with practical evaluation requirements<\/li>\n<li>Optimize processing timelines and minimize amendment cycles<\/li>\n<li>Ensure compliance throughout the product lifecycle in the market<\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><strong>MedNovum\u2019s services include:<\/strong><\/p>\n<ul style=\"text-align: justify;\">\n<li>Consulting on product classification and registration strategy<\/li>\n<li>Reviewing and completing legal and scientific dossiers<\/li>\n<li>Representing enterprises in product declaration registration procedures<\/li>\n<li>Advising on labeling, advertising, and post-market compliance<\/li>\n<li>Supporting appropriate legal structures (importer\/MAH) aligned with business strategy<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Please provide product information so that the MedNovum team can conduct a preliminary feasibility assessment and propose an appropriate registration roadmap in accordance with Vietnamese law. We are committed to providing timely responses with clear, transparent analysis and practical guidance to support the Client\u2019s market entry plan.<\/p>","protected":false},"excerpt":{"rendered":"<p>\u0110\u0102NG K\u00dd TH\u1ef0C PH\u1ea8M CH\u1ee8C N\u0102NG \u2013 B\u01af\u1edaC \u0110I CHI\u1ebeN L\u01af\u1ee2C KHI TH\u00c2M NH\u1eacP TH\u1eca TR\u01af\u1edcNG VI\u1ec6T NAM Trong nh\u1eefng n\u0103m g\u1ea7n \u0111\u00e2y, Vi\u1ec7t Nam \u0111\u00e3 n\u1ed5i l\u00ean nh\u01b0 m\u1ed9t<\/p>","protected":false},"featured_media":2225,"template":"","danh_muc_dich_vu":[16],"class_list":["post-2224","dich_vu","type-dich_vu","status-publish","has-post-thumbnail","hentry","danh_muc_dich_vu-thi-truong-viet-nam"],"acf":[],"_links":{"self":[{"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/dich_vu\/2224","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/dich_vu"}],"about":[{"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/types\/dich_vu"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/media\/2225"}],"wp:attachment":[{"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/media?parent=2224"}],"wp:term":[{"taxonomy":"danh_muc_dich_vu","embeddable":true,"href":"http:\/\/mednovum.com.vn\/en\/wp-json\/wp\/v2\/danh_muc_dich_vu?post=2224"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}