Vietnam Market Entry: Foreign Ownership, Retail Licence and Tax
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: What should be considered when setting up a company in Vietnam to trade devices?
A: Four things: (1) establishment form (representative office, branch or foreign-invested company); (2) business scope, which must include medical devices; (3) the additional licence required for retail; (4) physical conditions (Article 40 of Decree 98 on personnel and warehousing).
Q: Are there foreign ownership limits?
A: For medical device trading itself, Vietnam sets no specific foreign ownership cap, but retail distribution carries an additional licensing requirement. Under Article 5.1(a) of Decree 09/2018/NĐ-CP, a foreign-invested enterprise (FDI) engaged in retail distribution must obtain a trading licence for retail distribution. FDI status covers: (1) a foreign investor among the shareholders or owners; (2) more than 50% of charter capital held by another entity that is itself more than 50% foreign-owned; (3) more than 50% of charter capital held by a foreign investor and that entity together.
This means that the entry requirements for wholesale (B2B) and retail (B2C) device trading in Vietnam differ, and any retail activity needs a separate assessment.
Q: How are the physical conditions met?
A: Under Article 40 of Decree 98: at least one technical staff member with the required qualification; warehousing meeting requirements on area, ventilation, dryness, cleanliness, distance from sources of contamination and storage conditions in the instructions for use; suitable vehicles; and, where there is no owned warehouse or vehicle, a contract with a service provider is sufficient. The Trading Eligibility Declaration (for Class B/C/D) is then filed with the provincial Department of Health under Article 41, at VND 1,500,000 in the reduced period and VND 3,000,000 from 2027.
Q: What should be noted on tax?
A: Vietnam applies different VAT rates to medical devices and ordinary goods: devices attract a lower rate, non-device goods the ordinary rate, and the applicable rate is the one in force under Vietnamese tax law at the time. This is one practical reason to register key accessories and consumables separately as devices, since it secures the supply of parts and affects tax treatment (see Part 30). The applicable treatment must follow Vietnamese tax law and the position of the competent tax authority.
Q: Own company or independent MAH: which to choose?
A: Look at SKU count and market commitment. An own company carries establishment, staff, warehousing, tax and annual compliance costs and gives full autonomy; an independent MAH is cheaper, faster to start and flexible on channel changes (Part 34). Testing stage or few SKUs: independent MAH. Many SKUs and a long-term presence: own company. Annual maintenance costs can differ several-fold, so run the numbers before deciding.
Practical note: do not set up a company before obtaining the certificate. The best sequence is to use an independent MAH to obtain the certificate and run one to two years of market validation, establish real sales volumes, SKU mix and channel patterns, and only then decide whether to incorporate. Scale assumptions for incorporation are then backed by data rather than optimism.
Verification checklist (26 October 2026): (1) Decree No. 09/2018/NĐ-CP, Article 5.1(a) (foreign-invested retail distribution licence) and the FDI criteria; (2) Decree 98/2021/NĐ-CP, Article 40 (conditions) and Article 41 (procedure and fees); (3) Decision No. 2495/QĐ-BYT (4 August 2025), procedure list; (4) MOH Notice No. 645/TB-HTTB (2 July 2025), fees; (5) the current Vietnamese tax rules on VAT rates for medical devices, as applied by the competent authority.
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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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.
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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.
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