Vietnam Fast Track: Reference-Country Approval in 10 Working Days
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: What is Vietnam’s fast track?
A: A reference-country expedited review mechanism introduced into Decree 98 by Decree 07/2023/NĐ-CP. Where a Class C or D device already holds a Certificate of Free Sale (CFS) or marketing authorisation issued by the competent authority of a reference country, the MOH may apply a shortened review procedure, reducing the timeline from the standard maximum of about 90 days to as little as about 10 working days.
Q: Which approvals are recognised?
A: The reference-country authorities recognised by Vietnam include, subject to the decrees and to what the MOH publishes at the time:
- the United States FDA;
- Australia TGA;
- Health Canada;
- Japan’s Ministry of Health, Labour and Welfare and PMDA;
- EU member states, the United Kingdom and Switzerland;
- China NMPA;
- Korea MFDS;
- other authorities recognised by the Vietnamese government.
Devices that already hold an import licence, circulation registration number or CFS issued by the Vietnamese government may also use the fast route.
Q: Does holding a CE mark guarantee the fast track?
A: Not necessarily. Three conditions must be met at once. First, the document must be issued by a reference-country competent authority; a CE certificate issued by a notified body is different in nature from a CFS issued by a competent authority, and the two are often confused in practice. Second, the document must be within its validity period and cover the device being declared. Third, the document itself must have completed the notarisation and legalisation chain required by Vietnam, assessed under Apostille rules after 11 September 2026. If any one of the three is missing, the fast-track request is refused and the file reverts to standard review.
Q: Is the fast track worth pursuing?
A: Yes, but count the whole cost. Standard review runs to 90 days against about 10 working days on the fast track, a difference that can reach two or three months. For projects facing a tender window or a supply interruption, that gap often decides the outcome. Pursuing the fast track nonetheless takes investment: document preparation, the legalisation chain and template adaptation. For products with no reference-country approval at all, the sensible course is to schedule on the standard route rather than force an unsuitable move in the name of speed.
Practical note: the most realistic fast route for Chinese manufacturers is an NMPA registration certificate or CFS. Two operational points matter. The document must map to the specific models being declared. And it must be confirmed in advance whether the document meets Vietnam’s requirements on the issuing body for a CFS, since the Chinese issuing body has to align with what Vietnam recognises. Confirming these two points lifts the success rate of a fast-track request markedly.
Verification checklist (26 October 2026): (1) Decree No. 07/2023/NĐ-CP (3 March 2023), provisions on the fast track relating to Article 32a of Decree 98; (2) the current text of Articles 32 and 32a of Decree 98/2021/NĐ-CP; (3) current MOH/IMDA publication of the reference-country list and the scope of the fast track; (4) Circular No. 59/2023/TT-BTC and Circular No. 64/2025/TT-BTC (official fees); (5) the date the Hague Apostille Convention entered into 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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