Vietnam Device Regulation 2021-2026: Timeline of Key Changes
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
This is a living page: the rules keep changing, so follow the MOH/IMDA announcements in force at the time.
Q: What has changed in Vietnam’s device rules over the past few years?
A: Within five years Vietnam completed the move from the old system (Decree 36/2016 and 169/2018) to the Decree 98 system, and adjusted it continuously between 2021 and 2026 through three amending decrees and several ministerial circulars. The key dates are:
| Date | Instrument | Key change |
|---|---|---|
| 8 November 2021 (in force 1 January 2022) | Decree 98/2021/NĐ-CP | Replaced Decree 36/2016 and 169/2018; established the A/B/C/D classes, the two-tier route of declaration and circulation registration, price declaration, advertising publication and post-market management |
| 1 July 2022 | Requirements related to Article 62 of Decree 98 | The requirement for device advertising content to be published on the MOH portal took effect |
| 1 August 2022 | Circular 05/2022/TT-BYT | The classification rule set (16 general rules plus IVD-specific rules) |
| 3 March 2023 | Decree 07/2023/NĐ-CP | Amended Articles 21.2, 22, 32.3.c, 37.6 and 38; introduced the reference-country expedited pathway; deficiency rules (90 days / three rounds) |
| 30 December 2023 | Decree 96/2023/NĐ-CP | Article 147 package amendment: rewrote Chapter IV on clinical studies and added a priority processing mechanism (10 working days) |
| 1 January 2024 | CSDT mandatory | Class C/D dossiers must use the ASEAN CSDT template |
| 1 January 2025 | Decree 04/2025/NĐ-CP | Amended Article 76 and extended the transitional arrangements to 30 June 2025 |
| January 2025 | Institutional renaming | DMEC → IMDA (Department of Medical Infrastructure and Medical Equipment) |
| 30 June 2025 | Circular 64/2025/TT-BTC | Device fees halved, valid 1 July 2025 to 31 December 2026 |
| 1 July 2025 | End of the transition period | Decree 98 fully applied; arrangements such as import on a classification document ceased |
| 2 July 2025 | MOH Notice 645/TB-HTTB | Published the full reduced-period fee schedule |
| 4 August 2025 | Decision 2495/QĐ-BYT | Administrative procedure list and handling levels (for example, Class B/C/D Trading Eligibility Declarations handled by the provincial Department of Health) |
| 2025 | Circular 44/2025/TT-BYT | Mandatory LoA template |
| 1 January 2026 | Article 147.19 of Decree 96/2023 in force | Class C/D dossiers must include the competent authority’s clinical investigation completion certificate |
| 23 January 2026 | Decree 37/2026/NĐ-CP | New labelling rules, replacing 43/2017 and 111/2021; font size of at least 0.9 mm and other requirements |
| 11 September 2026 | Hague Apostille Convention in force for Vietnam | Public documents from Contracting Parties are legalised by Apostille; consular legalisation is no longer required |
| 31 December 2026 | Circular 64/2025 expires | The 50% fee reduction ends and standard rates resume |
Q: Which changes matter most to companies?
A: Ranked by reach, four watersheds:
- 1 July 2025 — the transition period ends and the route of importing on a classification document disappears; companies already holding certificates must complete formal registration;
- 1 January 2026 — the clinical investigation completion certificate is added for Class C/D, markedly raising timelines and costs for high-risk devices;
- 23 January 2026 — the new labelling rules take effect, putting small-pack products under redesign pressure;
- 11 September 2026 — Apostille takes effect and the legalisation chain changes form (shorter, but Vietnamese notarised translations are still required).
Q: What else is still changing?
A: Three areas to watch: (1) IMDA taking over delegated functions, with issuance for Class C/D, post-licensing inspection, suspension, recall and revocation progressively confirmed as its responsibility; (2) updates to the administrative procedure list, issued from time to time in the form of QĐ-BYT; (3) the end of the reduced-fee period (31 December 2026). In addition, the consolidated document of the Decree 98 framework is updated as an MOH document and is the main reference for day-to-day queries.
Practical note: turn this timeline into an internal regulatory register and review it quarterly. Watch four variables: (1) whether a new amending decree appears; (2) whether the reduced-fee period is extended; (3) how Decree 37/2026 is applied in practice and its transitional arrangements; (4) changes to the list of Apostille Contracting Parties. One register, kept in one place and shared across the company, stops sales, regulatory and logistics from working from different assumptions.
Verification checklist (26 October 2026): (1) Decree 98/2021/NĐ-CP (8 November 2021); (2) Decree 07/2023/NĐ-CP (3 March 2023); (3) Decree 96/2023/NĐ-CP (30 December 2023), Article 147; (4) Decree 04/2025/NĐ-CP (1 January 2025); (5) Circular 05/2022/TT-BYT (1 August 2022); (6) Circular 44/2025/TT-BYT (LoA template); (7) Circular 59/2023/TT-BTC and Circular 64/2025/TT-BTC (30 June 2025); (8) MOH Notice 645/TB-HTTB (2 July 2025); (9) Decision 2495/QĐ-BYT (4 August 2025); (10) Decree 37/2026/NĐ-CP (23 January 2026); (11) the Hague Apostille Convention in force for Vietnam (11 September 2026).
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
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