Vietnam Device Fee Schedule: Registration, Import and Export Fees
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: What other administrative fees apply besides registration fees?
A: Under the reduced-period rates published in MOH Notice No. 645/TB-HTTB (2 July 2025) for 1 July 2025 to 31 December 2026, the main device fees are:
| Fee item | Reduced-period rate (VND) |
|---|---|
| Registration review, Class A device | 500,000 |
| Registration review, Class B device | 1,500,000 |
| Registration review, Class C or Class D device | 3,000,000 |
| Review of an import licence application for a device | 1,000,000 |
| Export licence application for a Class C/D device, reviewed by the MOH | 500,000 |
| Export licence application for a Class A/B device, reviewed at provincial level | 500,000 |
| Issuance of a registration certificate for device testing activities | 1,500,000 |
| Supplementary or amended issuance of a registration certificate for device testing activities | 1,500,000 |
| Declaration of manufacturing eligibility for devices | 1,500,000 |
| Declaration of trading eligibility (purchase and sale) for Class B/C/D devices | 1,500,000 |
Q: How do the standard rates work?
A: All the figures above are after the 50% reduction. Standard rates are set by Circular 59/2023/TT-BTC, and Circular 64/2025/TT-BTC applies 50% during the reduced period. For the Trading Eligibility Declaration, Decision 2495/QĐ-BYT (4 August 2025) states VND 1,500,000 in the reduced period and VND 3,000,000 from 1 January 2027, which shows that the standard rate is about twice the reduced rate.
Q: Which items cost twice as much?
A: Note the supplementary and change line: a supplementary or amended registration certificate for device testing activities is also charged at VND 1,500,000, the same as first issuance. That means changes are not free, and the cost must be built into any change budget.
Q: Which source governs the fee?
A: The current MOH announcement and procedure lists such as Decision 2495/QĐ-BYT. Ministry of Finance circulars (TT-BTC) set the rates, and the MOH applies them to specific administrative items through procedure lists (QĐ-BYT) and notices (TB-HTTB). The reduced period has a defined end date, and standard rates resume when it expires.
Practical note: in the annual budget for a Vietnam project, put administrative fees in a separate table and estimate them under three headings: first application, changes, and annual maintenance. Vietnam’s absolute fees are low, but the fact that change fees equal first-application fees means that frequent small changes are not cheap. Batching changes is more economical, provided the change deadlines are not breached.
Verification checklist (26 October 2026): (1) MOH Notice No. 645/TB-HTTB (2 July 2025), full table of reduced-period device fees; (2) Circular No. 59/2023/TT-BTC (standard rates); (3) Circular No. 64/2025/TT-BTC (30 June 2025, 50% reduction, 1 July 2025 to 31 December 2026); (4) Decision No. 2495/QĐ-BYT (4 August 2025), administrative procedure list and handling levels.
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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GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.
GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.
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What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.
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