Vietnam MAH: Why Overseas Manufacturers Cannot Hold the Certificate

Q: Can a manufacturer outside Vietnam hold the registration in its own name?

A: No. Vietnam’s circulation registration number or Declaration of Applicable Standards must be held by a Vietnamese legal entity acting as the MAH (Marketing Authorization Holder). An overseas manufacturer cannot file or hold the certificate in its own name; it can only appoint a Vietnamese entity through a LoA.

Q: How should this arrangement be understood in legal terms?

A: The key lies in the definition of the Product Owner in Article 2.5 of Decree 98/2021. A Product Owner is an organisation or individual that (a) supplies the device under its own name or under a trademark or trade name it controls, and (b) is responsible for designing, manufacturing, assembling, processing, labelling, packaging, repairing or determining the intended use of the device. The same provision states that a Product Owner need not be the holder of the circulation certificate or the party filing the Declaration of Applicable Standards, because a Product Owner may authorise another party to apply for and hold the certificate. This is the legal basis of the Vietnamese MAH system.

Q: What qualifications does the MAH need?

A: Two hard conditions: (1) it is a Vietnamese legal entity (an enterprise, cooperative, household business or other entity established under law); (2) if it trades Class B/C/D devices, it has completed the Trading Eligibility Declaration (Bản công bố đủ điều kiện mua bán) and meets the personnel, warehousing and transport conditions of Article 40 of Decree 98 (see Part 32).

Q: What responsibilities does the MAH carry?

A: The MAH is the rights holder named on the certificate, and its responsibilities run across the whole lifecycle: the accuracy of the application dossier, post-market vigilance and adverse event reporting, suspension of circulation and recall of defective devices, change notification, price declaration, cooperation with MOH/IMDA and provincial Department of Health inspections, and document retention. These obligations cannot be transferred to the manufacturer by contract. An agreement can only set out recourse between the parties; external liability stays with the MAH.

Q: What should be checked when choosing an MAH?

A: Four verification criteria: (1) a business licence scope that covers medical devices; (2) a completed Trading Eligibility Declaration searchable on the MOH portal; (3) technical staff and warehousing and transport arrangements meeting Article 40; (4) circulation numbers actually held in its name that can be verified. Look also at governance capability: whether a named person handles vigilance and portal monitoring (deficiency notices), and whether the partner will commit in the agreement to “forward any notice within 24 hours of receipt”.

Practical note: treat the MAH as a compliance liability partner in the Vietnamese market, not as a “certificate-processing agent”. The test is simple: ask three questions. How are deficiency notices received and forwarded? What is the SOP for adverse event reporting? How quickly can an import authorisation be issued when the distributor changes? A partner that cannot answer them is a pass-through holder, not a capable one.

Verification checklist (26 October 2026): (1) Decree 98/2021/NĐ-CP, Article 2.5 (definition of Product Owner); (2) Decree 98/2021/NĐ-CP, Article 21(2) (as amended by Decree 07/2023, owner of the circulation number); (3) Decree 98/2021/NĐ-CP, Articles 25, 26 and 27 (LoA and declaration/registration); (4) Decree 98/2021/NĐ-CP, Articles 40 and 41 (trading eligibility conditions and procedure); (5) the Trading Eligibility Declaration publication section of the MOH portal.