Vietnam medical device regulations

Amendment decree signed 1 January 2025, effective on signature (Công báo số 181 + 182 of 28 January 2025). Amends khoản 2-4 of Điều 76 of Decree 98/2021/NĐ-CP: the medical-device import licences issued under those clauses remain usable through 30 June 2025, with the amended transition clauses quoted in full. Ingested Điều 1-3 from the official gazette PDF. The former row credited the June 2025 extension to IVD registration validity via a commercial English mirror; the gazette text extends import-licence validity, not registration validity.

Detailed implementation circular for Decree 98/2021. Provides classification rules for risk levels A, B, C, D and list of devices requiring import licenses. Stays blocked: the only located official-host copy (IMDA Singapore) carries a mangled legacy-font text layer, and the Vietnamese gazette-hosted PDF has no text layer. The implementing-circular family was consolidated as VBHN số 12/2026/TT-BYT (10 July 2026), but its PDF is not directly resolvable on a chinhphu.gov.vn host — the strongest follow-up candidate once its datafiles URL is indexed.

Primary decree governing medical device management in Vietnam. Replaces Decree 36/2016. Establishes ASEAN-harmonized classification, registration procedures, and import requirements. Stays blocked: no official English translation exists on any Vietnamese government host, and this URL is a commercial luatvietnam.vn mirror; the official Vietnamese consolidation is ingested under vn-decree-98-vietnamese.

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.

Ministry of Health Vietnam regulates medical devices through the Medical Equipment and Construction Department. Oversees device registration, import permits, and market surveillance.

Historical amendment decree (signed 31 December 2018, effective on signature; Công báo số 37 + 38 of 11 January 2019) restating the amended articles of Decree 36/2016/NĐ-CP on medical device management — device types and classification principles, licensed classification facilities, manufacture declaration, and metrology/calibration — plus the Phụ lục I-XII forms. Repealed by Decree 98/2021/NĐ-CP from 1 January 2022. Ingested Điều 1-3 (Điều 1 quotes the restated Articles 4-10 and 49-52 of Decree 36/2016 as body text) plus the forms annex from the official gazette PDF. The former row pointed at an English luatvietnam.vn mirror.

Historical classification circular (superseded January 2022). Established 4-class risk system A, B, C, D based on ASEAN guidelines. Now replaced by Circular 05/2022. Stays blocked as a superseded document with no text-layer copy on any official host: the online gazette archive starts in 2017, the Ministry of Justice databases (phapluat.gov.vn, vbpl.vn) sit behind a 403 bot-wall, and the MOH portal is F5-blocked; only commercial mirrors and image-only copies remain.