Fees & processing-time comparison
A direct comparison of state filing fees and statutory processing times across the main Vietnamese health-product regimes. Each row gives the statutory rate from the governing instrument; where TT 64/2025/TT-BTC applies a 50 % temporary reduction (valid 2025-07-01 to 2026-12-31), the discounted rate is shown alongside.
TT 64/2025/TT-BTC applies a 50 % temporary reduction to the fee schedules of Circulars 41/2023/TT-BTC and 59/2023/TT-BTC for the window 2025-07-01 to 2026-12-31. Circular 67/2021/TT-BTC (food sector) is not discounted.
| Category | Fee (statutory) | Statutory time | Validity | Governing instrument |
|---|---|---|---|---|
| Drug registration — new (chemical) |
11 000 000 VND
After discount: 5 500 000 VND
|
up to 12 months (full Drug Advisory Council review) | 5 years |
TT 41/2023/TT-BTC mục 1.1 · Luật Dược 105/2016 sửa bởi Luật 44/2024/QH15
Source →
|
| Drug registration — renewal |
4 500 000 VND
After discount: 2 250 000 VND
|
3 months; existing registration stays valid uninterrupted if filed ≥ 12 months before expiry | 5 years (renewed term mirrors initial) |
TT 41/2023/TT-BTC mục 1.2 · Luật 44/2024/QH15 Đ.1 §30 (hiệu lực 01/01/2025)
Source →
|
| Health supplement (TPBVSK) — registered declaration |
1 500 000 VND
|
21 working days (TPBVSK) · 7 working days (medical nutrition, special-purpose foods, < 36 months infant nutrition) | No statutory expiry; re-declare on material change to product, claims or safety standard |
TT 67/2021/TT-BTC · NĐ 15/2018/NĐ-CP Điều 8
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|
| Self-declared food (tự công bố) |
miễn phí
|
Effective immediately on publication; one copy filed with provincial authority | Open-ended; re-declare on any material change |
NĐ 15/2018/NĐ-CP Điều 4–5
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|
| Medical device — Class A notification |
1 000 000 VND
After discount: 500 000 VND
|
3 working days for Sở Y tế e-portal publication of receipt | No expiry (indefinite) |
TT 59/2023/TT-BTC mục III · NĐ 98/2021/NĐ-CP sửa bởi NĐ 07/2023
Source →
|
| Medical device — Class B notification |
3 000 000 VND
After discount: 1 500 000 VND
|
3 working days for Sở Y tế e-portal publication of receipt | No expiry (indefinite) |
TT 59/2023/TT-BTC mục III · NĐ 98/2021/NĐ-CP sửa bởi NĐ 07/2023
Source →
|
| Medical device — Class C / D registration (số lưu hành) |
6 000 000 VND
After discount: 3 000 000 VND
|
60 working days standard MOH review (sub-tracks vary) | No expiry (indefinite) — replaced the prior 5-year regime |
TT 59/2023/TT-BTC mục III · NĐ 98/2021/NĐ-CP Điều 30–32 sửa bởi NĐ 07/2023
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|
| Cosmetic — phiếu công bố sản phẩm |
500 000 VND
After discount: 250 000 VND
|
3 working days (DAV for imports · Sở Y tế for domestic manufacture) | 5 years |
TT 41/2023/TT-BTC mục 1.3 · TT 06/2011/TT-BYT Điều 7
Source →
|
Notes
- New chemical drug registration has multiple sub-tracks under Drug Advisory Council review, with statutory windows from 60 to 365 days. The "12 months" in the table is the outside bound for a new chemical drug requiring full review; generic or change-of-packaging tracks are shorter.
- "miễn phí" for self-declared food refers to the state fee only. Companies still bear the cost of an ISO 17025-accredited test report (typically 3–8 million VND per product) and any optional notarisation.
- Medical-device số lưu hành is now indefinite (Decree 07/2023 amending Decree 98/2021 removed the prior 5-year expiry; post-market surveillance and recall powers are unaffected).
- The TPBVSK Giấy tiếp nhận đăng ký bản công bố sản phẩm has no statutory expiry under Decree 15/2018; re-declaration is required on any material change to the formulation, claims, or applicable QCVN.
Reference information only; not legal or medical advice. Before filing, verify against the source documents and the current guidance from the competent authority.