情報ポータル · Việt Nam
医薬品、栄養、Việt Nam の医薬品規制に関するリファレンス
Medibase は EN / VI / JA の多言語情報ポータルで、医薬品、サプリメント、食品に関する 参考データに加え、Việt Nam における医薬品規制（đăng ký、đấu thầu、giá thuốc、 cảnh giác dược）の専門ガイドページを集約しています。
参考情報 · 医療上または法律上の正式な助言の代わりとはなりません。
Medibase のコンテンツ
本ポータルがカバーする4分野。
Việt Nam の医薬品規制
DAV、Bộ Y tế、Quốc hội の公式文書へのリンクを引用元として付した、 厳選された4本の参考ページです。
Regulatory Affairs
Authorization, registration, and post-market obligations under the Drug Administration of Vietnam (DAV).
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).
Pricing
Drug-price declaration, winning tender prices, and the price-management framework under the 2023 Price Law and the 2024 Pharmacy Law amendment.
Pharmacovigilance
Adverse drug reaction reporting, vaccine-safety surveillance, and risk management under the Drug Administration of Vietnam and the National DI & ADR Centre.
Việt Nam のサプリメント規制
Cục An toàn thực phẩm (VFA) が規制する thực phẩm bảo vệ sức khỏe (TPBVSK) に関する 参考ページ5本です。
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.
Ingredient & formulation
Permitted ingredients, prohibited substances, vitamin/mineral limits, and scientific evidence required for health-protection foods.
Labelling & claims
Vietnamese-language labelling, mandatory disclosures, and restrictions on health claims for functional foods and TPBVSK.
Advertising compliance
Pre-approval of advertising content for health-protection foods by the Vietnam Food Administration (VFA), with mandatory disclosures and prohibited claims.
Post-market surveillance
Inspections, sampling, recalls, and administrative penalties for non-compliant health-protection foods and unregistered supplements.
Việt Nam の医療機器規制
Nghị định 98/2021/NĐ-CP およびその改正に基づく医療機器管理に関する 参考ページ5本です。
Risk classification
The four-tier risk classification system (A, B, C, D) for medical devices in Vietnam under Decree 98/2021/NĐ-CP.
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.
Price management
Price posting and transparency obligations for medical devices under Decree 98/2021/NĐ-CP and the public MOH price portal.
Post-market & quality control
Vigilance, incident reporting, recalls, QMS (ISO 13485), and IMDA inspections for medical devices on the Vietnamese market.
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.
Việt Nam の化粧品規制
Thông tư 06/2011/TT-BYT および Hiệp định Hòa hợp Mỹ phẩm ASEAN に基づく 化粧品管理に関する参考ページ4本です。
Cosmetic Product Notification
Pre-market notification (Phiếu công bố sản phẩm mỹ phẩm) under Circular 06/2011/TT-BYT, transposing the ASEAN Cosmetic Directive.
Ingredient Safety & Annexes
Banned and restricted substances, permitted preservatives, UV filters and colourants under the ACD annexes adopted in Vietnam.
Product Claims & Classification
Cosmetic vs drug borderline products, permitted claims under the ASEAN Cosmetic Claim Guidelines, and rules for cosmetic advertising.
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.
Việt Nam の食品規制
Luật 55/2010 および Nghị định 15/2018 に基づく食品安全に関する 参考ページ5本です。Bộ Y tế (MOH)、Bộ Nông nghiệp (MARD)、Bộ Công Thương (MOIT) が 共同で管理しています。
Product self-declaration
How prepackaged processed foods reach the Vietnamese market via the self-declaration regime under Decree 15/2018/NĐ-CP.
Technical standards & testing
National technical regulations (QCVN), Vietnamese standards (TCVN), and accredited laboratory testing requirements for food.
Food labeling
Mandatory Vietnamese-language labels, required content, expiry-date conventions, allergens, and GMO disclosures for food sold in Vietnam.
Specialized management
Three-ministry split of food-safety oversight between MOH, MARD, and MOIT under Decree 15/2018/NĐ-CP, Annex IV.
Food safety certificates
Certificate of Eligibility for Food Safety Conditions — when it is required, who issues it, exemptions, validity, and renewal.