Medibase
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Information portal · Vietnam

Vietnam's Healthcare Compliance Reference Gateway

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.

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Reference only · not a substitute for medical or legal advice.

What's on Medibase

Four areas the portal covers.

Regulatory information

Cited reference pages on Vietnamese drug registration, public tendering, pricing, and pharmacovigilance.

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Drug price lookup

Search declared wholesale and winning tender prices, cross-referenced against the public DAV portals.

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Public-source search

Structured search across DAV registrations, VSS tender results, VFA health-supplement certificates, and hospital tender notices.

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EN VI JA

Multilingual EN / VI / JA

Every reference entry and regulatory page is available in English, Vietnamese, and Japanese.

EN VI JA

Browse by category

Five product categories — each with its own regulatory guides and reference data.

Medicines

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Supplements

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Medical devices

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Cosmetics

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Foods

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Vietnamese pharmaceutical regulation

Four curated reference pages, with citations linking to official documents from DAV, the Ministry of Health, and the National Assembly.

Registration · GMP · Labelling

Regulatory Affairs

Authorization, registration, and post-market obligations under the Drug Administration of Vietnam (DAV).

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Drug Registration Process in Vietnam

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.

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Tendering · BHYT · Market access

Tendering & Market Access

Public procurement of medicines under the 2023 Bidding Law and Circular 40/2025/TT-BYT, and reimbursement through Vietnam Social Security (BHYT).

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Declared · Tender · Negotiated prices

Pricing

Drug-price declaration, winning tender prices, and the price-management framework under the 2023 Price Law and the 2024 Pharmacy Law amendment.

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ADR · AEFI · Safety alerts

Pharmacovigilance

Adverse drug reaction reporting, vaccine-safety surveillance, and risk management under the Drug Administration of Vietnam and the National DI & ADR Centre.

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Vietnamese supplements regulation

Five reference pages on health-protection foods (TPBVSK), regulated by the Vietnam Food Administration (VFA).

TPBVSK · Declaration · VFA

Market entry & registration

How health-protection foods (TPBVSK) and other functional foods enter the Vietnamese market under the Food Safety Law and Decree 15/2018/NĐ-CP.

Health Supplement Registration Process in Vietnam

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.

Ingredients · Vitamins · Banned subs.

Ingredient & formulation

Permitted ingredients, prohibited substances, vitamin/mineral limits, and scientific evidence required for health-protection foods.

Vietnamese label · Disclaimer

Labelling & claims

Vietnamese-language labelling, mandatory disclosures, and restrictions on health claims for functional foods and TPBVSK.

Pre-approval · 10 days

Advertising compliance

Pre-approval of advertising content for health-protection foods by the Vietnam Food Administration (VFA), with mandatory disclosures and prohibited claims.

Inspection · Recall · Penalty

Post-market surveillance

Inspections, sampling, recalls, and administrative penalties for non-compliant health-protection foods and unregistered supplements.

Vietnamese medical-device regulation

Five reference pages on medical-device management under Decree 98/2021/NĐ-CP and its amendments.

Class A · B · C · D

Risk classification

The four-tier risk classification system (A, B, C, D) for medical devices in Vietnam under Decree 98/2021/NĐ-CP.

MAC · ASEAN CSDT

Market access & licensing

Marketing authorisation (số lưu hành) and import licensing for medical devices in Vietnam, with the ASEAN CSDT pathway and reference-country fast track.

Medical Device Registration Process in Vietnam

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 · MOH portal

Price management

Price posting and transparency obligations for medical devices under Decree 98/2021/NĐ-CP and the public MOH price portal.

Surveillance · Recall · Incidents

Post-market & quality control

Vigilance, incident reporting, recalls, QMS (ISO 13485), and IMDA inspections for medical devices on the Vietnamese market.

IVD · SaMD

IVD & Software as a Medical Device

Regulation of in-vitro diagnostic devices and software as a medical device in Vietnam — current rules and the gap in SaMD-specific guidance.

Vietnamese cosmetics regulation

Four reference pages on cosmetic-product management under Circular 06/2011/TT-BYT and the ASEAN Cosmetic Directive.

Notification · DAV · ASEAN

Cosmetic Product Notification

Pre-market notification (Phiếu công bố sản phẩm mỹ phẩm) under Circular 06/2011/TT-BYT, transposing the ASEAN Cosmetic Directive.

Cosmetic Notification Registration Process in Vietnam

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 subs. · Annexes · ACD

Ingredient Safety & Annexes

Banned and restricted substances, permitted preservatives, UV filters and colourants under the ACD annexes adopted in Vietnam.

Claims · Borderline · Ads

Product Claims & Classification

Cosmetic vs drug borderline products, permitted claims under the ASEAN Cosmetic Claim Guidelines, and rules for cosmetic advertising.

Vietnamese label · INCI · PAO

Labelling Requirements

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.

Vietnamese food regulation

Five reference pages on food safety under Law 55/2010 and Decree 15/2018, jointly managed by MOH, MARD, and MOIT.

Self-declaration · Decree 15

Product self-declaration

How prepackaged processed foods reach the Vietnamese market via the self-declaration regime under Decree 15/2018/NĐ-CP.

Food Product Registration Process in Vietnam

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.

QCVN · TCVN · ISO 17025

Technical standards & testing

National technical regulations (QCVN), Vietnamese standards (TCVN), and accredited laboratory testing requirements for food.

Vietnamese label · Allergens · GMO

Food labeling

Mandatory Vietnamese-language labels, required content, expiry-date conventions, allergens, and GMO disclosures for food sold in Vietnam.

MOH · MARD · MOIT

Specialized management

Three-ministry split of food-safety oversight between MOH, MARD, and MOIT under Decree 15/2018/NĐ-CP, Annex IV.

ATTP cert · 3-year · Exemptions

Food safety certificates

Certificate of Eligibility for Food Safety Conditions — when it is required, who issues it, exemptions, validity, and renewal.

Latest news & articles

Regulatory updates, official notices, and curated commentary

General

Ministry of Health publishes internal procurement handbook for drugs and medical supplies — Decision 1589/QĐ-BYT (3 June 2026)

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.

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General

Telemedicine in Vietnam — regulations and conditions, with a focus on foreign companies

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.

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General

Universities training medicine and pharmacy in Vietnam — a 2026 map of history, faculties and students

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.

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General

Conditions for medical practice in Vietnam — what businesses, hospitals/clinics and individual practitioners must meet under the 2024-2026 framework

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.

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Medicine

Pharmacovigilance obligations of drug manufacturers in Vietnam — what changes under Luật 44/2024 and Circular 12/2025

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.

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About Medibase

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.

Library size: 4 medicines 4 supplements 5 foods