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Ministry of Health Decree

Decree 98/2021/ND-CP (Vietnamese)

Nghị định 98/2021/NĐ-CP về quản lý thiết bị y tế (VBHN 08/VBHN-BYT)
VietnamGovernment of VietnamGeneralEffective 1 January 2022
What this code is

Decree 98/2021/ND-CP (Vietnamese) is the official GOV identifier for “Nghị định 98/2021/NĐ-CP về quản lý thiết bị y tế (VBHN 08/VBHN-BYT)”. Decree 98/2021/ND-CP (Vietnamese) is the official identifier GOV uses for this instrument.

Instrument
Decree
Full name
Decree 98/2021/ND-CP (Vietnamese)
Category
General
Source links
Authority source
Vietnamese
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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77 articles · 1 language version
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
6 March 2026
Effective
1 January 2022
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

About this regulation

Nghị định 98/2021/NĐ-CP về quản lý thiết bị y tế (VBHN 08/VBHN-BYT)

Official consolidated text (văn bản hợp nhất số 08/VBHN-BYT, issued 6 March 2026 by the Minister of Health) of Decree 98/2021/NĐ-CP on medical device management, as amended by Decrees 07/2023/NĐ-CP, 96/2023/NĐ-CP, 85/2024/NĐ-CP, 04/2025/NĐ-CP, and 342/2025/NĐ-CP (the chain the VBHN itself lists). Covers classification, manufacture, clinical trials, circulation numbers and registration, import licences, pricing, advertising, and surveillance for devices, IVDs, and medical equipment. Ingested Điều 1-77 plus the Mẫu forms annex from the official Government Portal PDF; the consolidation footnotes marking each amended provision remain in the block text.

Decree 98/2021/ND-CP (Vietnamese) is the official identifier GOV uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.