Vietnam MAH Distributor Authorisations: How Many, and What Changes
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: How many distributors can one MAH authorise?
A: There is no limit. Article 47(2) of Decree 98/2021 allows the holder of a circulation registration number (the MAH) to issue import authorisations to importers and distributors. In practice the MAH may authorise any number of importers and distributors, and no individual authorisation affects the validity of the circulation number.
Q: What does this mean for the manufacturer?
A: It means channel control can stay with the manufacturer. The optimal structure is: manufacturer → independent MAH holding the certificate → MAH issuing import authorisations to multiple distributors at the manufacturer’s direction. The result:
- Changing distributor: the MAH simply revokes or adds an authorisation, with no change to the registration certificate;
- Parallel channels: hospital, distribution and e-commerce channels can be authorised at the same time;
- Negotiating leverage: the manufacturer is no longer held to ransom by a single distributor.
Q: How does this differ from Indonesia?
A: Vietnam is markedly more flexible on this point. Indonesia’s LoA and holding arrangements are more restrictive, in practice close to one holder per brand, and changing distributor often involves action at registration-certificate level and a waiting period. Vietnam splits holding from importing and distribution under Article 47(2), and changing distributor without touching the certificate is a route the rules explicitly support.
Q: What should the authorisation letter contain?
A: At minimum: the full names and addresses of the authorising party (MAH) and the authorised party (importer), a list of authorised products by model, the authorisation period, the scope (import, distribution, after-sales service), the authorisation number, and a revocation clause (the manufacturer’s right to require revocation). Like the LoA, this is a commercial control document and should not be drafted unilaterally by the counterparty.
Q: Does the authorisation need to be filed with the authority?
A: The import authorisation itself is a commercial and compliance document between the MAH and the importer, not an administrative approval item. The importer must still meet the trading conditions (for Class B/C/D, a completed Trading Eligibility Declaration), and where the import involves an import licence (Article 48 of Decree 98), that licence must be obtained separately.
Practical note: fix three points in the MAH service agreement. (1) The MAH must issue or revoke an import authorisation within X working days of a written instruction from the manufacturer. (2) Scope and term are set by the manufacturer. (3) The MAH may not authorise third parties without the manufacturer’s consent. These three sentences decide who ultimately controls the channel, and the difference is considerable.
Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, Article 47(2) (the holder issues import authorisations); (2) Decree 98/2021/NĐ-CP, Articles 40 and 41 (Trading Eligibility Declaration); (3) Decree 98/2021/NĐ-CP, Article 48 (cases requiring an import licence); (4) Decree 96/2023/NĐ-CP, Article 147 (priority processing for holder and importer changes); (5) Decree 98/2021/NĐ-CP, Article 2.5 (Product Owner).
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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