Scenario: A German medical-device company wants both to sell into Vietnamese hospitals and to manufacture here. After initial research, it finds product registration in Vietnam far more complex than expected, while rivals have sold through distributors for years. This article separates the two games — selling domestically and manufacturing in Vietnam — because their logic is entirely different.
Product registration: the longest road
Selling medical devices in Vietnam requires product circulation registration with the health regulator, classified by risk level (low to high). Higher-risk devices mean heavier dossiers: clinical trials, international quality certifications, detailed technical documentation. Actual processing time often runs far longer than the paper regulations suggest, especially for devices never previously circulated.
The strategic consequence: if the goal is fast domestic revenue, do not start by building a factory. Start with a distributor experienced in registration, while preparing product dossiers in parallel. The factory is step two, once products have market footing.
Manufacturing for export: the legitimate shortcut
Conversely, manufacturing in Vietnam for export is a much shorter road: no domestic circulation registration is needed for export-only products, and investment procedures follow the standard manufacturing-project track. Vietnam offers labor-cost advantages, good logistics positioning, and free-trade agreements giving exports preferential tariffs in many markets.
The clearest open segments: components, medical consumables (syringes, infusion sets, high-quality medical gloves), in-vitro diagnostics (IVD), and contract assembly for global brands (OEM/ODM). These segments face few registration barriers and enjoy stable export demand.
Public-hospital tenders: a separate game
Public hospitals — the largest buyer — operate under tender law with strict dossier, origin and pricing requirements. Foreign investors cannot “sell directly” but typically go through winning bidders and distributors. Manufacturing in Vietnam gives advantages on origin and delivery time in tender dossiers, but does not replace a local partner’s tendering capability.
Note: preference for domestically manufactured devices in medical tenders is an increasingly clear trend. A Vietnamese factory today is a tender advantage two to three years out — a strategic investment, not immediate revenue.
Investment procedures and quality requirements
Medical-device manufacturing projects follow procedures under the Investment Law 143/2025/QH15 (effective 1 March 2026): IRC, then ERC under the Enterprise Law 59/2020/QH14. Plants must meet good manufacturing practice for medical devices and internationally recognized quality-management systems — prerequisites for both exporting and future domestic registration.
High-tech projects in the medical field may be considered for CIT incentives under the Corporate Income Tax Law 67/2025/QH15 (effective 1 October 2025). The specific level is determined during approval.
A recommended two-phase roadmap
Phase one (first year): enter via a distributor — complete circulation registration for two or three flagship products, join tenders through the partner, measure real demand. Phase two: with sales traction and game knowledge, build the manufacturing plant (starting from components, consumables or OEM assembly), serving exports while gradually localizing the registered portfolio. This order avoids the common mistake: finishing the factory only to discover products cannot sell pending registration.
Frequently asked questions
Does manufacturing medical devices purely for export need Vietnamese registration?
No. Products made in Vietnam solely for export do not need domestic circulation registration. The plant must still meet the production and quality standards of the importing markets.
How long does medical-device registration take?
It depends on risk classification: low-risk devices move faster, while high-risk devices (implants, interventional) can take years due to clinical-trial and technical-appraisal requirements. Hire a specialized registration consultant from the start rather than figuring it out alone.
Can a wholly foreign-owned company distribute medical devices in Vietnam?
Yes, provided it meets requirements on warehousing, professional personnel, and declarations under medical-device management rules. Pharmaceutical distribution is far more restricted — do not confuse the two fields.
What tender advantages does Vietnamese manufacturing bring?
Advantages on goods origin, delivery time, and on-site warranty and maintenance capability — all scored criteria in tender dossiers. The trend favoring domestically produced goods is also a long-term strategic plus.
This article has been quality-reviewed by the FLAW AI Legal Council