Medibase
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Regulatory clarity · 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.

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

Medicines

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Medical devices

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Cosmetics

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Vietnamese pharmaceutical regulation

11 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).

Procedure · Dossier · SRA

Drug Registration Process in Vietnam

End-to-end analysis of marketing-authorisation (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.

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).

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.

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.

GDP · GPP · Distribution

Pharmaceutical Distribution & Retail in Vietnam

Licensing for wholesalers, community pharmacies, drug shops, commune health-station drug cabinets, and traditional-medicine retailers under the post-1 July 2025 framework — the Pharmacy Business Eligibility Certificate (GCN đủ điều kiện kinh doanh dược), Good Distribution Practice (GDP), Good Pharmacy Practice (GPP), and Good Storage Practice (GSP), as reshaped by amended Pharmacy Law 44/2024/QH15 and Decree 163/2025/NĐ-CP.

Narcotics · Psychotropics · Precursors

Special-Control Medicines in Vietnam — Narcotic, Psychotropic, Precursor, Radioactive

Lifecycle regulation of narcotic, psychotropic, precursor and radioactive medicines under the parallel Pharmacy Law and Anti-Drug Law chains — Decree 163/2025/NĐ-CP and Circular 18/2026/TT-BYT (effective 16 July 2026) for the pharmacy side, Law 73/2021/QH14 and Decree 28/2026/NĐ-CP for the substance lists, and Law 94/2025/QH15 (Atomic Energy) with Decree 332/2025/NĐ-CP overlaying radioactive medicines.

Traditional medicine · Materia medica

Traditional Medicine & Medicinal Materials in Vietnam

Registration, quality, cultivation (GACP), and retail of thuốc cổ truyền, vị thuốc cổ truyền and dược liệu — under Pharmacy Law Chapter VI as amended by Law 44/2024/QH15, the post-1 July 2025 stack (Decree 163/2025/NĐ-CP, Circulars 29/2025 + 32/2025 + 31/2025/TT-BYT), the GACP Circular 19/2019/TT-BYT, and the national 2030 programme under Decision 1893/QĐ-TTg.

Import · Export · Customs

Drug Import & Export in Vietnam

Two regimes — ordinary commercial trade in drugs with valid marketing authorisation, and the special import-export of drugs without registration number — under Pharmacy Law Article 60 and new Article 53a (added by Law 44/2024/QH15), Decree 163/2025/NĐ-CP Chapter IV, the Customs Law 54/2014/QH13, and the 1961 Hague Apostille Convention from 11 September 2026.

Trials · Bioequivalence · IRB

Clinical Trials & Bioequivalence in Vietnam

Authorisation, GCP, ethics review and BE-study requirements under Pharmacy Law Chapter XI as implemented by Decree 163/2025/NĐ-CP Article 23, the new Circular 50/2025/TT-BYT (effective 27 February 2026; replaces Circular 29/2018/TT-BYT, Article 9 of Circular 10/2020/TT-BYT, and Circular 08/2014/TT-BYT), Circular 43/2024/TT-BYT on ethics committees, and Circular 07/2022/TT-BYT on the BE-required substance list.

Vaccines · Biologicals · NICVB

Vaccines & Biological Products in Vietnam

Dedicated registration, NICVB lot release, GMP for biologicals, cold chain, AEFI pharmacovigilance, and the National Immunisation Programme — under Pharmacy Law Article 2 definitions, Decree 163/2025/NĐ-CP, Circular 12/2025/TT-BYT (registration), Circular 28/2025/TT-BYT (GMP), Circular 11/2025/TT-BYT (GSP), Decree 104/2016 + Circular 34/2018/TT-BYT (TCMR and AEFI), Circular 26/2013/TT-BYT (blood products), and the Pharmacy Law amendments by Law 44/2024/QH15.

Vietnamese supplements regulation

6 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. The 2026 reform package — Decree 46/2026/NĐ-CP, which was to replace Decree 15/2018/NĐ-CP — is currently suspended indefinitely by NQ 15/2026/NQ-CP and is not in operational force; Decree 15/2018 continues to apply.

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

8 reference pages on medical-device management under Decree 98/2021/NĐ-CP and its amendments (Decree 07/2023/NĐ-CP and Decree 04/2025/NĐ-CP, in force 1 January 2025).

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, Decree 96/2023/NĐ-CP, and Decree 04/2025/NĐ-CP (in force 1 January 2025) — 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.

Medical Device Labelling in Vietnam

Mandatory label content in Vietnamese, supplementary labels for imports, registration-number identification, expiry and lot, symbols and warnings, e-IFU rules and 2026 changes under Decree 37/2026/NĐ-CP (in force 23 January 2026; replaces Decree 43/2017 + Decree 111/2021), plus device-specific rules under Decree 98/2021/NĐ-CP (as amended by 07/2023, 96/2023 and 04/2025) and Circular 05/2022/TT-BYT.

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

Vietnam IVD & SaMD Regulation: Classification, Approval, Labelling

In-vitro diagnostic devices and software as a medical device in Vietnam: risk classification (Class A/B/C/D), approval workflow, expedited SRA pathway, product grouping, analytical + clinical testing evidence, labelling, and the SaMD guidance gap — under Decree 98/2021/NĐ-CP (as amended by Decree 07/2023, 96/2023 and 04/2025) and Circular 05/2022/TT-BYT.

Medical Device Import & Export in Vietnam

Risk-classified import and export of medical devices and IVDs under Decree 98/2021/NĐ-CP as amended by Decree 07/2023/NĐ-CP and Decree 04/2025/NĐ-CP, the IMDA registration regime, the Hague Apostille Convention from 11 September 2026, and the open WTO regime for foreign-invested distributors — a fully separate legal chain from the drug regime.

Vietnamese cosmetics regulation

6 reference pages on cosmetic-product management under Circular 06/2011/TT-BYT (amended by Circular 34/2025/TT-BYT, in force 2025-08-18) and the ASEAN Cosmetic Directive.

Cosmetic Market Entry in Vietnam — a Foreign-Company Guide

End-to-end reference for foreign cosmetic companies planning market entry to Vietnam — the ASEAN Cosmetic Notification pathway, who may hold the notification, dossier structure, timelines, fees, common rejection reasons, and the boundary between what a foreign company can do itself and what requires a Vietnamese partner. Not a registration-service brokerage — a reference guide plus free tools.

Notification · DAV · ASEAN

Cosmetic Product Notification

Pre-market notification (Phiếu công bố sản phẩm mỹ phẩm) under Circular 06/2011/TT-BYT (as amended by Circular 34/2025/TT-BYT, in force 2025-08-18), 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 — as amended by Circular 34/2025/TT-BYT (in force 2025-08-18) — transposing the ASEAN Cosmetic Directive. Covers the DAV / provincial-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

6 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 labelling

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.

Vietnamese healthcare practice, facilities & data

4 reference pages on medical-practice licensing, facility licensing, telemedicine and personal-data protection under Law 15/2023/QH15, Decree 96/2023/NĐ-CP, and the 2026 Personal Data Protection Law 91/2025/QH15.

CCHN KCB · 9-year renewal

Medical Practice Licensing in Vietnam

The Chứng chỉ hành nghề khám bệnh, chữa bệnh (CCHN KCB) regime for individual healthcare professionals — under Law on Medical Examination and Treatment 15/2023/QH15 (effective 1 January 2024, replacing Law 40/2009), Decree 96/2023/NĐ-CP, Circular 32/2023/TT-BYT (master implementing circular with the 120-credit-hour CME requirement), and the nine professional titles recognised by the 2023 reform.

GPHĐ KCB · Facility licence

Healthcare Facility Licensing in Vietnam

The Giấy phép hoạt động khám bệnh, chữa bệnh for hospitals, clinics and other facilities — under Law on Medical Examination and Treatment 15/2023/QH15 Chapter IV, Decree 96/2023/NĐ-CP, Circular 32/2023/TT-BYT, and the new basic quality standards in Circular 35/2024/TT-BYT (from 1 January 2025). The 2024 reform abolished the old hạng I/II/III classification for licensing purposes and introduced three professional-technical levels (cấp ban đầu, cấp cơ bản, cấp chuyên sâu).

Telemedicine · BHYT-payable

Telemedicine in Vietnam

Telemedicine (khám bệnh, chữa bệnh từ xa) formally codified for the first time in Law on Medical Examination and Treatment 15/2023/QH15 Article 53, with operating conditions in Decree 96/2023/NĐ-CP Article 87, the eligible-conditions list in Circular 30/2023/TT-BYT, and BHYT reimbursement extended to telemedicine from 1 July 2025. Cross-border foreign telemedicine providers must operate via a licensed Vietnamese facility; controlled substances cannot be remotely prescribed.

Personal data · DPIA · DPO

Personal Data Protection in Vietnamese Digital Health

How Luật 91/2025/QH15 — the first dedicated Personal Data Protection Law of Vietnam — and its implementing Nghị định 356/2025/NĐ-CP (both effective 1 January 2026) apply to health data: telemedicine platforms, electronic medical records, e-prescription, the national drug-traceability system, health-insurance data, and clinical-trial data. Health, biometric and genetic data are sensitive personal data. Cross-border transfers and DPO appointment are mandatory in scope. Sanctions are codified in Article 8 of the Law itself (up to 10× illegal revenue for unlawful sale, up to 5 % of prior-year revenue for cross-border transfer violations, up to VND 3 billion for other violations).

Latest news & articles

Regulatory updates, official notices, and curated commentary

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Medicine

Circular 32/2026/TT-BYT — new drug-registration framework from 1 October 2026

Issued 29 July 2026 by the Ministry of Health, Circular 32/2026/TT-BYT replaces Circular 12/2025/TT-BYT as the operating rulebook for marketing-authorisation of chemical drugs, vaccines, biologicals, herbal medicines and pharmaceutical materials. Traditional medicine (thuốc cổ truyền) stays under Circular 29/2025. What actually changes, transitional provisions for in-flight dossiers, and what MA holders should do in the next six weeks.

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Medicine

Circular 18/2026/TT-BYT — special-control drugs

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.

General

MOH procurement handbook — Decision 1589 (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 Vietnam 2026 — foreign-firm rules

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

Vietnam medical & pharmacy universities: 2026 map

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

Vietnam medical practice conditions 2024–2026

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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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: 30 medicines 24 supplements 30 foods 0 medical devices