Vietnam is one of the most promising medical device markets in Southeast Asia, but one of the more demanding to enter. Demand is increasing steadily, it imports the overwhelming majority of what it uses, and the regulatory framework has been rebuilt over the past few years.
This guide covers the three things a foreign manufacturer needs to understand before committing: the opportunity in the Vietnamese market, the regulatory pathway, and how to reach buyers through distribution and the hospital tender system.
Vietnam's medical device market
The fundamentals are strong for foreign companies planning to enter the market. Vietnam's medical equipment market was worth around US$1.67 billion in 2023, the eighth largest in the Asia-Pacific region. It's projected to reach roughly US$2.1 billion by 2026, growing at about 8% a year. Crucially for foreign manufacturers to know is that around 90% of medical equipment is imported, with the biggest exporters being China, South Korea, Japan, Germany, and the US. There is no large domestic industry to compete against in most device categories.
Vietnam has around 1,645 hospitals, including 384 private facilities, serving a population of more than 100 million people. Add an aging population, rising middle-class healthcare spending, and sustained government investment in upgrading public hospitals, and we can see the future of demand. Health insurance now covers around 94% of the population, among the highest coverage rates in the region, which underpins steady demand across the public hospital system.
One point worth setting expectations on early: this is not a fast market. Even experienced exporters should assume it takes 1 to 2 years to being commercially present. The companies that succeed treat an entry as a multi-year build, not a quick launch.
This medical device opportunity sits within a broader healthcare market that is expanding fast. For context on hospitals, pharmaceuticals, and the overall sector, see our article on Vietnam's healthcare and pharmaceutical market opportunities.
How medical devices are regulated
This is where most new entrants get caught out, because Vietnam rebuilt its medical device rules in the past few years and much of the guidance still circulating online is now out of date.
The Ministry of Health oversees the sector through the Infrastructure and Medical Device Administration (IMDA), a body renamed from DMEC in early 2025, which is a small sign of how much has moved recently. The bigger change is that the transitional shortcuts many companies relied on to get products into the market have now closed. Since mid-2025, foreign manufacturers have had to go through the full standard registration process, with none of the exceptions carried over from the old system.
If your Vietnam strategy was shaped before 2025, or if you are working from guidance that predates it, assume it is out of date and check it against the current rules before committing resources. This is an area where the cost of getting it wrong such as a rejected application, a delayed launch, a product stuck at the border is high.
Device classification: A, B, C, and D
Vietnam follows the ASEAN framework and classifies devices into four risk classes, from Class A (lowest risk) to Class D (highest). Classification determines what follows: which authority handles your device, what documentation you need, and how long approval takes.
Class A and B devices are handled at provincial level through the local Department of Health, via a declaration process. Class C and D devices require full Marketing Authorization registration with the Ministry of Health through the IMDA. A meaningful change under the current rules is that the registration holder now self-classifies the device as part of the application, rather than relying on a separately certified classification body as the old system required. Getting classification right is important as an incorrect classification can make the application invalid.
The registration process and what it requires
A few requirements are worth naming precisely, because they are non-negotiable and companies underestimate them.
A valid ISO 13485 certificate for the manufacturing facility is mandatory, with no exemption for any device class. Class C and D devices require the ASEAN Common Submission Dossier Template (CSDT), the standardized regional dossier format, while lower-risk Class A and B devices follow a simpler declaration procedure. You will also need a Certificate of Free Sale from your home market, and Vietnamese-language labeling and instructions for use.
There is one genuine advantage in the system: Marketing Authorization Codes do not expire. Once granted, a registration stays valid indefinitely unless withdrawn for a breach, which removes the renewal burden that exists in many other markets.
On timelines, be realistic. The statutory processing times and the real-world times have historically diverged, and the system worked through a significant registration backlog between 2022 and 2024 that drove much of the recent reform. Treat the statutory minimum as a best case, not an expectation, and build a conservative timeline into your launch plan.
The authorized representative requirement
This is the requirement that shapes the entire entry strategy, and it is often misunderstood. A foreign manufacturer without a legal entity in Vietnam must appoint a local authorized representative to hold the registration and manage the regulatory obligations. These include incident reporting, recalls, record-keeping, and communication with the authorities.
This is a legal requirement and it has some strategic consequences to you as a seller. Your authorized representative holds your market authorization, which means the relationship is of utter importance. If it is your distributor who holds your registration, changing distributors later becomes complicated, because the registration is tied to them. This is why the regulatory and commercial decisions cannot be made in isolation, who holds your registration is as important as who sells your product.
Finding a distributor for medical devices
Most foreign manufacturers reach the Vietnamese market through a local distributor, and choosing the right one is a decision with long consequences. The general principles of selecting and evaluating a Vietnamese distribution partner apply here but medical devices add specific requirements on top. Our guide to identifying and evaluating distributors in Vietnam covers the groundwork.
A capable medical device distributor needs strong regulatory capability, not just a sales team. It needs established relationships with hospitals and the procurement departments that buy devices. Depending on your product, it may need technical service capability, cold chain handling, or clinical support. And you need to decide whether your distributor will also act as your authorized representative or whether you keep those roles separate. Combining them is simpler, separating them gives you more control if the commercial relationship changes.
There is no single right answer, but it should be a conscious choice made early, not a default you back into.
Choosing the right distributor is one of the most consequential decisions when entering Vietnam. For a structured approach to identifying and evaluating partners, see our guide to distributors in Vietnam.
Selling into public hospitals and the tender system
The majority of medical device sales in Vietnam run through public hospital procurement, which operates on a tender system. Understanding how tenders work, how specifications are set, how price competition operates, and how relationships influence outcomes is crucial to not only have registered products, but products that sell.
From January 1st, 2027, medical devices in public tenders are classified into six groups based on technical standard compliance and other criteria. This will reshape how devices compete in public procurement, and companies entering the market now should factor the coming change into their positioning rather than being caught out by it.
Challenges for foreign companies
The regulatory framework is complex and still changing, which makes current, accurate guidance essential. The authorized representative requirement creates a dependency that has to be managed carefully. Vietnamese-language labeling, price declaration in the Ministry of Health system, and post-market obligations all add operational load. The public tender system exerts real price pressure. And competition from established players like GE, Philips, Medtronic, Siemens, and the major Japanese and Korean brands is significant in the higher-value categories.
None of this is a reason to stay out. It is a reason to enter in the right order, with the right partners, and with realistic expectations about timelines.
Getting the sequence right
The companies that struggle in Vietnam are usually the ones that find a distributor first and treat regulation as an afterthought. It should be the other way around. Confirm your device classification and your ISO 13485 and documentation position. Decide who will hold your registration, and appoint the right authorized representative. Complete registration. Then build the distribution and tender strategy on top of a compliant foundation.
Vietnam rewards companies that are patient, well-prepared, and willing to build properly. It is harder on those who treat it as a quick opportunity. The market is growing and so durably, and the import dependency means the opportunity for foreign manufacturers is there. But the entry has to be sequenced correctly, and the regulatory pathway has to come first.
