Information portal · Vietnam
Medibase is a multilingual EN/VI/JA portal that collects reference information on medicines, supplements, foods, medical devices, and cosmetics, alongside curated guides to Vietnamese pharmaceutical regulation — registration, tendering, pricing, and pharmacovigilance.
Reference only · not a substitute for medical or legal advice.
Four areas the portal covers.
Cited reference pages on Vietnamese drug registration, public tendering, pricing, and pharmacovigilance.
Search declared wholesale and winning tender prices, cross-referenced against the public DAV portals.
Structured search across DAV registrations, VSS tender results, VFA health-supplement certificates, and hospital tender notices.
Five product categories — each with its own regulatory guides and reference data.
Four curated reference pages, with citations linking to official documents from DAV, the Ministry of Health, and the National Assembly.
Authorization, registration, and post-market obligations under the Drug Administration of Vietnam (DAV).
End-to-end analysis of marketing-authorization (giấy đăng ký lưu hành) workflow at the Drug Administration of Vietnam (DAV) — legal basis, dossier requirements, evaluation steps, statutory vs real-world timelines, and practical pitfalls under the amended Pharmacy Law (44/2024/QH15, in force 1 July 2025) and Circular 12/2025/TT-BYT.
Public procurement of medicines under the 2023 Bidding Law and Circular 40/2025/TT-BYT, and reimbursement through Vietnam Social Security (BHYT).
Drug-price declaration, winning tender prices, and the price-management framework under the 2023 Price Law and the 2024 Pharmacy Law amendment.
Adverse drug reaction reporting, vaccine-safety surveillance, and risk management under the Drug Administration of Vietnam and the National DI & ADR Centre.
Five reference pages on health-protection foods (TPBVSK), regulated by the Vietnam Food Administration (VFA).
How health-protection foods (TPBVSK) and other functional foods enter the Vietnamese market under the Food Safety Law and Decree 15/2018/NĐ-CP.
End-to-end analysis of the đăng ký bản công bố sản phẩm workflow at the Vietnam Food Administration (VFA) for health-protection foods (TPBVSK) — legal basis, dossier requirements, evaluation steps, statutory vs real-world timelines, and the 2026 reform package under Decree 46/2026/NĐ-CP (effective 15 April 2026 after a 75-day suspension) replacing Decree 15/2018/NĐ-CP.
Permitted ingredients, prohibited substances, vitamin/mineral limits, and scientific evidence required for health-protection foods.
Vietnamese-language labelling, mandatory disclosures, and restrictions on health claims for functional foods and TPBVSK.
Pre-approval of advertising content for health-protection foods by the Vietnam Food Administration (VFA), with mandatory disclosures and prohibited claims.
Inspections, sampling, recalls, and administrative penalties for non-compliant health-protection foods and unregistered supplements.
Five reference pages on medical-device management under Decree 98/2021/NĐ-CP and its amendments.
The four-tier risk classification system (A, B, C, D) for medical devices in Vietnam under Decree 98/2021/NĐ-CP.
Marketing authorisation (số lưu hành) and import licensing for medical devices in Vietnam, with the ASEAN CSDT pathway and reference-country fast track.
End-to-end operational analysis of medical-device registration in Vietnam under Decree 98/2021/NĐ-CP, as amended by Decree 07/2023/NĐ-CP and Decree 96/2023/NĐ-CP — Class A published-declaration track at provincial Sở Y tế, Class B/C/D Marketing Authorisation Certificate (số lưu hành) track at MOH/DMEC, ASEAN CSDT structure, reference-country fast track, statutory vs real-world timelines, and the 2022–2024 backlog crisis that drove the reform package.
Price posting and transparency obligations for medical devices under Decree 98/2021/NĐ-CP and the public MOH price portal.
Vigilance, incident reporting, recalls, QMS (ISO 13485), and IMDA inspections for medical devices on the Vietnamese market.
Regulation of in-vitro diagnostic devices and software as a medical device in Vietnam — current rules and the gap in SaMD-specific guidance.
Four reference pages on cosmetic-product management under Circular 06/2011/TT-BYT and the ASEAN Cosmetic Directive.
Pre-market notification (Phiếu công bố sản phẩm mỹ phẩm) under Circular 06/2011/TT-BYT, transposing the ASEAN Cosmetic Directive.
End-to-end operational analysis of the Phiếu công bố sản phẩm mỹ phẩm workflow under Circular 06/2011/TT-BYT, transposing the ASEAN Cosmetic Directive — DAV/DOH split, National Single Window (VNSW) submission, dossier contents, Product Information File (PIF) maintenance, statutory and real-world timelines, renewal and post-notification changes.
Banned and restricted substances, permitted preservatives, UV filters and colourants under the ACD annexes adopted in Vietnam.
Cosmetic vs drug borderline products, permitted claims under the ASEAN Cosmetic Claim Guidelines, and rules for cosmetic advertising.
Mandatory label contents in Vietnamese, INCI ingredient declaration, batch number, period-after-opening (PAO) and manufacturer information under Decree 43/2017 and Circular 06/2011/TT-BYT.
Five reference pages on food safety under Law 55/2010 and Decree 15/2018, jointly managed by MOH, MARD, and MOIT.
How prepackaged processed foods reach the Vietnamese market via the self-declaration regime under Decree 15/2018/NĐ-CP.
End-to-end analysis of the đăng ký bản công bố hợp quy (conformity-declaration registration) and tự công bố sản phẩm (self-declaration) tracks for food in Vietnam — legal basis, the two-track perimeter under Decree 46/2026/NĐ-CP, dossier requirements, agency timelines, inter-ministerial allocation (MOH / MARD / MOIT), and the 2026 reform package.
National technical regulations (QCVN), Vietnamese standards (TCVN), and accredited laboratory testing requirements for food.
Mandatory Vietnamese-language labels, required content, expiry-date conventions, allergens, and GMO disclosures for food sold in Vietnam.
Three-ministry split of food-safety oversight between MOH, MARD, and MOIT under Decree 15/2018/NĐ-CP, Annex IV.
Certificate of Eligibility for Food Safety Conditions — when it is required, who issues it, exemptions, validity, and renewal.
Regulatory updates, official notices, and curated commentary
Signed 1 June 2026 by Deputy Minister Nguyễn Tri Thức and effective 16 July 2026, Circular 18/2026/TT-BYT replaces Thông tư 20/2017 and 27/2024 as the implementing instrument for the Pharmacy Law and Decree 163/2025/NĐ-CP. Five chapters, nineteen articles, and a same-day reclassification of Etomidate and Carisoprodol as psychotropic substances.
A 69-page operations manual aligned with Prime Minister's Directive 24/CT-TTg (29/7/2024), built on Luật Đấu thầu 22/2023/QH15 (as amended by Luật 57/2024 and Luật 90/2025), Nghị định 214/2025/NĐ-CP and Thông tư 40/2025/TT-BYT — covering procurement planning, open competitive tender, competitive offer, direct procurement and designation, for entities under the Ministry of Health.
Khám bệnh, chữa bệnh từ xa is no longer an exception scheme. From 1 January 2024, Luật 15/2023/QH15 codifies it as a regulated form of medical practice; Nghị định 96/2023/NĐ-CP and Thông tư 32/2023/TT-BYT pin the operational conditions; Quyết định 2628/QĐ-BYT remains the operational backbone of the inter-facility network; and a data / cybersecurity overlay — Nghị định 13/2023/NĐ-CP, Luật Giao dịch điện tử 2023, Nghị định 53/2022/NĐ-CP, Luật Bảo vệ dữ liệu cá nhân 2025 — applies on top. For a foreign company, the entry path is constrained at three layers: the WTO schedule and Luật Đầu tư 2020 (corporate vehicle), the practising licence and language rule for the doctor (Điều 21), and the data-localisation and consent regime (Nghị định 13/2023, Luật BVDLCN). A synthesis of the law text on Cổng thông tin Chính phủ and ThuVienPhapLuat, the implementing decree and circular, the 2020 telehealth project decision, and analytical coverage from kcb.vn, xaydungchinhsach.chinhphu.vn and LuatVietnam.
From the École de Médecine de l'Indochine founded in Hanoi in 1902 to the ~35+ accredited universities and academies operating today, Vietnam's medical and pharmaceutical training system now spans the historic flagships, regional public universities, the Vietnam Military Medical University and a growing cluster of private schools led by VinUniversity. A synthesis read against Luật Khám bệnh, chữa bệnh 2023 (Luật 15/2023/QH15), Nghị định 96/2023/NĐ-CP, and the National Medical Licensing Exam phasing in from 1 January 2027.
From 1 January 2024, Luật Khám bệnh, chữa bệnh số 15/2023/QH15 replaced the 2009 law and rewrote the architecture of medical practice. Nghị định 96/2023/NĐ-CP and Thông tư 32/2023/TT-BYT detailed the new conditions for both individual practitioners (Giấy phép hành nghề) and establishments (Giấy phép hoạt động). From 1 January 2025 the three-tier system (cấp ban đầu / cấp cơ bản / cấp chuyên sâu) replaced the old four-tier scheme, and from 1 July 2026 Nghị quyết 21/2026/NQ-CP delegates practising licence authority from Bộ Y tế to Chủ tịch UBND cấp tỉnh. A synthesis of the law text on Cổng thông tin Chính phủ and ThuVienPhapLuat, the implementing decree and circular, the delegation resolution, and analysis from kcb.vn, xaydungchinhsach.chinhphu.vn and LuatVietnam.
From 1 July 2025, the amended Pharmacy Law (Luật 44/2024/QH15) and the new drug-registration circular (Thông tư 12/2025/TT-BYT) took effect together, reshaping the operational duties of marketing-authorisation holders, manufacturers, importers and distributors. The 2021 National Pharmacovigilance Guideline (Quyết định 122/QĐ-BYT) survives as the technical backbone. A synthesis of the consolidated Pharmacy Law (VBHN 39/VBHN-VPQH / 76/VBHN-VPQH), DAV guidance, and industry analysis from LuatVietnam, ThuVienPhapLuat, the canhgiacduoc.org.vn DI&ADR portal, Lexology and Dione.
Medibase aggregates publicly available reference information from the Drug Administration of Vietnam (DAV), the Ministry of Health, Vietnam Social Security, and curated reference materials. Every regulatory citation links back to its official source.
The pages on Medibase are intended as a reference and do not replace professional medical advice or formal legal counsel. When using the information for registration, tendering, or commercial purposes, verify against the source text at the Official Gazette (Công báo) and the DAV portal.
