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Regulatory news & curated articles

Regulatory updates, official notices, and curated commentary — organised by section: medicines, supplements, foods, medical devices, and cosmetics.

Total articles: 10

All 10 Medicine 3 Supplement 1 Food 2 Medical device 0 Cosmetic 0 General 4

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General 2026-06-07

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.

#regulatory #procurement #dau-thau #mua-sam-cong #quyet-dinh-1589-2026 #bo-y-te #chi-thi-24-ct-ttg-2024 #luat-dau-thau-22-2023 #luat-57-2024 #luat-90-2025 #nghi-dinh-214-2025 #thong-tu-79-2025-btc #thong-tu-80-2025-btc #thong-tu-40-2025-byt #mua-sam-thuoc #mua-sam-hoa-chat #mua-sam-vat-tu-xet-nghiem #mua-sam-thiet-bi-y-te #e-hsmt

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.

#regulatory #kham-chua-benh-tu-xa #telemedicine #luat-15-2023 #nghi-dinh-96-2023 #thong-tu-32-2023 #quyet-dinh-2628 #nghi-quyet-21-2026 #foreign-investment #luat-dau-tu-2020 #wto-commitments #du-lieu-ca-nhan #nghi-dinh-13-2023 #an-ninh-mang #giao-dich-dien-tu #ho-so-benh-an-dien-tu

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.

#regulatory #kham-chua-benh #hanh-nghe-y-te #luat-15-2023 #nghi-dinh-96-2023 #thong-tu-32-2023 #nghi-quyet-21-2026 #giay-phep-hanh-nghe #giay-phep-hoat-dong #hoi-dong-y-khoa-quoc-gia #cap-chuyen-mon-ky-thuat