Case Study: A Hospital and Home-Care Catalog Through Vietnam Medical Device Registration

The catalog was already selling on three continents. Blood-pressure monitors and infrared thermometers for the home, nebulizers, hemodialysis needles, an endoscopy consumables family with a higher-risk generation coming behind it — CE marked, FDA cleared, and wanted by hospital buyers in Ho Chi Minh City. What the manufacturer did not have was a way to be the legal owner of any of it in Vietnam.

Its distributor had already offered to solve that. It would hold the licences itself, at no charge.

The offer that would have cost the most

The offer was sincere, and it is the one nearly every manufacturer receives. A foreign company cannot register a device in Vietnam in its own name: an eligible Vietnam-based entity has to hold or submit the market authorization and act as the local regulatory contact — the Marketing Authorization Holder — and that entity's name goes on the Vietnamese label as the organization responsible in-country. A distributor volunteering for the role makes a hard problem disappear in a single email.

The assumption underneath the offer was that the holder is an administrative box, and that a partner willing to tick it for nothing is simply being helpful. The authorization belongs to whoever holds it. Had the distributor held these, every later negotiation — margin, a second distributor in the north, an exit — would have been conducted with the manufacturer's own market access sitting on the far side of the table. Transfer between holders is not a promise any partner can honestly make in the abstract; Vietnam's procedures decide what is possible, not the supply agreement. Free at signature, and priced at whatever the relationship is worth on the day it goes wrong.

The manufacturer declined and split the roles. Our Vietnamese entity took the holder position as an independent registrant whose only function is the regulatory one, and the distributor stayed a distributor — free to be replaced, doubled or out-competed without a single registration moving. That is the arrangement our in-country representation model exists to create, and the reason the document base built over the following three years kept compounding instead of resetting: the same holder filed all of it.

The afternoon the catalog split in two

The next decision looked administrative and set the entire calendar. Vietnam classifies devices and IVDs into four risk classes under Decree 98/2021/ND-CP, following ASEAN Medical Device Directive and GHTF logic, and classification turns on intended use, duration of body contact, invasiveness, whether the device is active, and whether it sustains life. Mapped against the rules on our classification and grouping page, the catalog fell cleanly into two populations that go to two different authorities.

Most of it — the monitors, the thermometers, the nebulizers, the consumables, the existing endoscopy items — landed in Class A and Class B. Those go to the provincial health department where the holder is established, on a declaration of applied standards (công bố tiêu chuẩn áp dụng), and the filings in this program went through the Ho Chi Minh City health department. The review is a completeness and consistency check. Nobody re-examines the device from first principles.

The generation coming behind it — the higher-risk endoscopy products — was Class C, and Class C is a different activity entirely: a marketing authorization registration reviewed substantively by the Ministry of Health, where the reviewer assesses the device rather than the paperwork.

Grouping was settled at the same desk, before a page of dossier existed. Devices sharing intended use, legal manufacturer and risk class can go on one application and one certificate — families, systems, sets — which on a catalog this wide is the difference between registering a product line and registering every model in it. Accessories went the other way: regulated in their own right, and separately registered unless bundled with a parent device.

Filing the easy half first, on purpose

The manufacturer's instinct was to lead with the flagship. The higher-risk endoscopy generation was the product the business case rested on, so it should go in first and the rest could follow behind it. That is the order most catalogs are filed in, and it is backwards.

The declarations went first instead, because the declaration route is quick by construction: a filing checked for completeness and consistency, not a review to be waited out — our Vietnam regulations guidance notes many clear in under a week. And the CE certificates and FDA clearances sitting in the manufacturer's files, filed away as proof the products were serious, turned out to be worth more than that here: an approval from a reference market — the US, EU, Japan, Canada or Australia, plus the United Kingdom, China, South Korea and Switzerland — is what later qualified the Class C work for Vietnam's fast-track registration form. The approvals were not a credential in Vietnam. They were a lane, saved for where the route actually uses them.

So the home-care and consumable products went in first and began selling while the expensive work was still being written. The first year of the program contained no Class C filing at all — declarations only, Class A and Class B.

What those first filings really bought had little to do with the devices in them.

They stood up the holder. The entity had to be established, connected to the authority's systems and printed on the Vietnamese label before anything could be sold, and doing that against a Class A declaration rather than a Class C dossier put the operational learning where a mistake was cheap.

They built the document base — and this is where the pre-filing review earned its place. Two findings recur constantly in this work, and both surfaced here.

Quality certification was considered settled: the company held a current ISO 13485 certificate and had held one for years. What had never been read closely was its scope, which did not cleanly cover every manufacturing site behind the catalog. A certificate can be entirely valid and still not cover what is being filed. Submitted as it stood, that is a deficiency discovered late, at the worst possible moment; caught beforehand, it was a certificate reissue.

The letter of authorization was the second. It had been drafted narrowly enough to cover the initial submission and nothing after it — the kind of document that works once and then needs reissuing at every amendment for years afterwards. Both were fixed while the stakes were still a low-risk declaration. The certificate of free sale evidence went through the same review.

They also built the Vietnamese translation pipeline. Labels and instructions for use must be in Vietnamese, and the labeling decree itself changed under the program — Decree 37/2026/ND-CP replaced the old general-labeling rules in January 2026. Goods can still be imported on the original label where it carries the product name, the origin, and the foreign manufacturer's name and address, but the compliant Vietnamese label has to be on the product before it is put into circulation. Built once against simple products, that pipeline was reusable. Built later, under deadline, for a Class C device, it sits on the critical path. Our labeling requirements page carries the mandatory content.

The step up

In the program's second year, Class C arrived.

By then the only genuinely new work was the part that cannot be shortcut anyway. The holder existed. The certificate scopes and authorization documents had been through a review cycle. The translation pipeline was running. What remained was the substance: a dossier built on the ASEAN Common Submission Dossier Template, and a clinical evaluation that was no longer a formality — clinical evaluation is often required at Class C and D, presented as a clinical evaluation report drawn from literature, from clinical experience with similar devices, or from investigation where little experience exists, with technical and performance evidence proportionate to the risk rather than merely present.

This is what the flagship-first instinct costs. Lead with the Class C product and the holder relationship, the ISO 13485 scope and the Vietnamese labeling all get debugged simultaneously, against the one dossier where every week of delay is most expensive.

The endoscopy family is the clearest way to see the whole method, because it made the same journey in miniature. It entered on Class A and B declarations in 2024, continued as Class B work through 2025, and produced its first Class C registration in 2026 — a single product family walking the same path the catalog walked, arriving at substantive review only once everything around the dossier had stopped being a variable.

It was not the only thing on that route in those years. Drug-eluting coronary stents, interventional cardiology catheters, a percutaneous mitral-valve intervention device set, cranio-maxillofacial plates, mesh and screws, resorbable hemostatic materials, dental and biological bone substitutes, dermatology laser systems in both CO2 and Nd:YAG variants and Cone Beam CT imaging went through Ministry of Health review from the same desk across 2025 and 2026 — implantables, interventional cardiology and energy-emitting equipment, the categories where a regulator wants evidence rather than a form.

Both routes, running at once

The program never left the declaration route behind. Class B declarations kept going in alongside the Class C work, because they kept converting reference-market approvals the manufacturer already held into revenue while substantive reviews were in progress. By the third year the balance had tipped: half of everything filed was Class C, and the Class A tail had run out.

Underneath the new filings, a second workload had quietly started — the duties owed on everything already registered. Authorizations under Decree 98 carry no fixed expiry, and that fact is read the same wrong way almost every time: granted, therefore finished. There is no renewal cycle to diarise, so nothing announces itself. In force, those authorizations require an ISO 13485-compliant quality system, batch-level traceability (Vietnam does not yet run a full UDI system), retained dossier and distribution records, and structured post-market surveillance. Vigilance has its own clock, and it starts earlier than most manufacturers expect: on a warning of potential serious risk, the holder must notify affected healthcare facilities and complete the investigation within 30 days of becoming aware — a duty triggered by knowledge of a risk, not by a confirmed incident, with serious incidents themselves reported to the authority under the vigilance procedures.

Change control was the duty that bit hardest as the catalog grew. Decree 98 splits changes in two: those on the notifiable list — a holder's name or address, labeling details — are handled by self-notification to the authority, a ten-working-day mechanism with no approval step, while substantive changes to the device go back through registration itself. Knowing which side of that line a planned revision falls on is what keeps it off the critical path, and our post-market guidance carries the detail. This is also where a narrowly drawn letter of authorization would have been paid for repeatedly, had it not been rewritten in year one.

The ground moved twice

The framework did not hold still while any of this was happening.

Decree 98/2021/ND-CP is the base, but the version in force kept shifting underneath the program: Decree 07/2023/ND-CP amended it, Decree 96/2023/ND-CP followed, and Decree 04/2025/ND-CP amended it again, landing mid-program in the same year the Class C work began.

The manufacturer had arrived with a Vietnam entry plan already drafted from English-language guidance found online. Parts of it described a route that no longer existed. Transition measures around Decree 98 have moved several times, expired import-license extensions are still quoted in secondary sources today, and none of that material announces its own expiry — it reads exactly as authoritative as the current rules. The plan was rewritten before anything was filed. What governs a submission is the route, dossier and fee in force on its filing date, not the ones current when the project was scoped.

Then the arithmetic changed. Finance Ministry Circular 64/2025/TT-BTC halved the government fees for applications filed from 1 July 2025 — announced to the device sector through Ministry of Health Notice 645/TB-HTTB — and set the reduction to expire on 31 December 2026. Nothing announced since extends it. For a catalog still being brought over in waves, that converted a fee schedule into a calendar: filings made before the window closes cost half of what the same filings cost after it. The remaining declarations were sequenced accordingly. Our note on the 50% fee reduction has the detail.

The outcome, and the bill

The registrations are in force — the low-risk catalog on declarations through the Ho Chi Minh City health department, the endoscopy line's higher-risk generation on Ministry of Health registration — with our Vietnamese entity as holder, the distributor still a distributor, nothing lapsed, and the products in the hospitals that asked for them.

What a program shaped like this one costs, at published rates:

Official MOH fees, per product

Fees are per product, currently reduced under Circular 64/2025/TT-BTC through 31 December 2026, and subject to change.

Our flat annual fee

The ladder is $2,000 for the first device and $500 for each additional device to ten. It covers dossier preparation and submission, in-country representation as Marketing Authorization Holder, translation, modifications, distributor authorization and post-market support; government fees, certified translations and translation from languages other than English are separate. A three-year contract locks the rates.

Priced at those rates, a mix shaped like this one — four Class B products on declarations and one Class C registration — comes to $4,000 per year in service fees plus roughly US$360 in one-time government fees, a first-year total near US$4,360, of which the government's share is under a tenth. That ratio is the argument for printing the service number: for a Class B device the state wants about US$60, and everything else quoted is service. A different mix prices out differently — the fee calculator does that arithmetic.

Doing this for your product line

The order this engagement followed is the order that works. Settle who holds the authorization before anything is filed, and keep that role outside your sales channel. Classify and group the whole catalog against Vietnam's rules rather than assuming a home-market class carries over. File the low-risk products first, let them convert the CE or FDA approvals you already hold into early revenue, and let them stand up the holder, the document base and the Vietnamese labeling while the stakes are low. Fix the ISO 13485 scope and the letter of authorization before submission, not after. Then step up to Class C onto groundwork that already exists — and keep both routes running afterwards, with change control planned around the amendment clock.

Start with the Vietnam market page, see how the same decisions played out under ANVISA in our Brazil endoscope case study, or, if the catalog is crossing several markets at once, our global medical device registration service coordinates them together. Or talk to our team about your line.