Vietnam Registration Fees: Circular 59/2023 and the 50% Window
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: How much are Vietnam’s official registration fees?
A: Very low. Under the standard rates of Circular 59/2023/TT-BTC (Ministry of Finance):
| Class | Standard rate (VND) |
|---|---|
| Class A | 1,000,000 |
| Class B | 3,000,000 |
| Class C | 6,000,000 |
| Class D | 6,000,000 |
Q: How much is actually paid now?
A: Half. Under Circular 64/2025/TT-BTC (issued 30 June 2025) and as announced in MOH Notice No. 645/TB-HTTB (2 July 2025), medical device fees are reduced by 50% from 1 July 2025 to 31 December 2026:
| Class | Reduced-period rate (VND) |
|---|---|
| Class A | 500,000 |
| Class B | 1,500,000 |
| Class C | 3,000,000 |
| Class D | 3,000,000 |
Q: Which items does the 50% reduction cover?
A: It applies to applications newly submitted on or after 1 July 2025, including registration of medical device circulation registration numbers, import and export licence applications, registration certificates for testing and inspection activities, and declarations of manufacturing or distribution eligibility. The key limitation: dossiers submitted before 1 July 2025 are not adjusted retroactively and no refund is made.
Q: Are official fees the main cost?
A: No, and nowhere near. A Class C official fee is only VND 3 million after the reduction, whereas the actual total cost of a Class C/D project in Vietnam typically runs from several thousand to tens of thousands of US dollars. The main components are MAH service fees, translation, notarisation and legalisation, CSDT preparation, testing and clinical evidence, and local warehousing and staff. Treating official fees as the bulk of the budget is the most common budgeting error in Vietnam projects.
Q: What happens when the reduced-fee period ends?
A: Under Circular 64/2025 the reduced period runs to 31 December 2026, after which standard rates return (A: VND 1 million; B: VND 3 million; C and D: VND 6 million). Taking the Trading Eligibility Declaration procedure published in Decision 2495/QĐ-BYT (4 August 2025) as an example, the fee is stated explicitly as VND 1,500,000 from 1 July 2025 to 31 December 2026 and VND 3,000,000 from 1 January 2027.
Practical note: the right way to use the 50% window is to bring forward any SKU that can be filed early into 2026, not to compress dossier preparation in order to save the fee. The amount saved is small against total project cost, and filing an incomplete dossier to catch the window invites a deficiency notice, which costs more. The correct order is: get the dossier right first, then use the window.
Verification checklist (26 October 2026): (1) Circular No. 59/2023/TT-BTC (standard rates: A VND 1,000,000; B VND 3,000,000; C and D VND 6,000,000); (2) Circular No. 64/2025/TT-BTC (30 June 2025, 50% reduction, valid 1 July 2025 to 31 December 2026); (3) MOH Notice No. 645/TB-HTTB (2 July 2025); (4) Decision No. 2495/QĐ-BYT (4 August 2025), procedure list and fees, including the return to standard rates from 2027.
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.
About GRZAN
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.
Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.
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.
Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.
Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.
Take your devices global with GRZAN
We work with manufacturers worldwide to open new markets with a clear regulatory pathway.
Contact us