EU Authorized Representative for Vietnam: Product Owner and Manufacturer of Record
Most Vietnamese device exports leave the country under somebody else's brand. That makes the first MDR question a commercial one rather than a technical one: who is the manufacturer of record? Vietnam's own framework, Decree No. 98/2021/ND-CP, already answers a version of it through the product owner concept, and the EU answer usually follows — until a plant decides to export under its own name, at which point the entire weight of Article 10 lands in Vietnam. This page works through both cases, and through what a Vietnamese circulation registration does and does not buy.
Decree 98 already asks the question Europe asks
Vietnam’s medical device framework contains a concept most Asian regimes leave implicit. Article 2(5) of Decree No. 98/2021/ND-CP defines the chủ sở hữu thiết bị y tế — rendered in the decree itself as product owner — as the organisation or individual that supplies the device under its own name, trade mark, design or trade name, or that takes responsibility for the design, manufacture, assembly, processing, labelling, packaging or repair of the device, or for defining its intended purpose.
Read that next to MDR Article 2(30) and the family resemblance is obvious. Both instruments separate the entity that owns the product from the entity that owns the building. For a Vietnamese plant that builds to a European customer’s drawings, this is the single most useful thing in the decree, because it means the answer to the European question has usually already been settled in the Vietnamese file: whoever is product owner in Vietnam is almost always the manufacturer in the Union. The problems start when the two answers diverge.
Số lưu hành: two instruments, four classes, one holder
Article 4 of the decree divides devices into four classes by potential risk: A low, B low-to-moderate, C moderate-to-high, D high. Article 21 then sets out that the circulation number is a declaration-of-applicable-standards number for Class A and B devices, and a circulation registration certificate number for Class C and D. Since the 2023 amendment the circulation number is of indefinite validity, save for numbers issued under the emergency provisions. Article 25 restricts who may stand in the name of that filing to a Vietnamese enterprise, cooperative or business household that is itself the product owner, one authorised by the product owner, or the resident representative office in Vietnam of a foreign trader in the same position.
None of this reaches the Union. A Class C circulation registration certificate is a national marketing authorisation issued on a national dossier; it is not a conformity assessment within the meaning of MDR Article 52, and no notified body may treat it as one. What survives the journey is the evidence beneath it.
The plant Europe requires you to name
Vietnamese contract manufacturing is where this page earns its keep, because MDR contains a provision that a lot of European brand owners discover late: "Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 29(4)." (MDR Art. 10(15))
In other words, the Vietnamese site is disclosed. Its identity goes into the Union device registration database as part of the manufacturer’s own submission. That has three consequences worth planning for. The site becomes visible to competent authorities as the actual production location. It becomes an obvious candidate for an unannounced audit by the brand owner’s notified body, which under Annex IX may audit the manufacturer’s suppliers and subcontractors. And the supply agreement, the quality agreement and the technical file all have to describe the same arrangement, because divergence between the contract and the EUDAMED entry is exactly the sort of thing that surfaces in a review.
When the Hai Phong line becomes the manufacturer
The other route is own-brand export, and it changes everything. A Vietnamese company that puts its own trade mark on a device and sells it into the Union is the manufacturer for MDR purposes, with the full weight of Article 10: the quality management system under Article 10(9), risk management across the device lifetime, a clinical evaluation under Article 61, technical documentation to Annex II and III, UDI assignment, post-market surveillance under Article 83, vigilance reporting under Article 87, and financial coverage proportionate to risk class and enterprise size under Article 10(16). MDR Article 11(4) puts those obligations beyond the reach of the mandate: they cannot be delegated to a representative at all.
Once a plant carries its own brand, its name and address appear on the label under Annex I Section 23.2(c), and directly beneath it: "if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;" (MDR Annex I, Chapter III, Section 23.2(d)) That single line is the visible half of a much larger obligation.
Electronics discipline is not device discipline
A large share of Vietnam’s device-adjacent output comes from plants with strong electronics heritage — surface-mount lines, IPC workmanship standards, ISO 9001, statistical process control that would embarrass many dedicated device factories. That capability transfers. What does not transfer is the documentary architecture MDR expects: design history that ties every requirement to verification evidence, a risk management file maintained under ISO 14971 across the whole lifecycle rather than closed at launch, software lifecycle records under IEC 62304 where firmware is involved, biological evaluation for anything patient-contacting, and change control that treats a component substitution as a regulated event. Manufacturing excellence is necessary and, on its own, insufficient.
Reading the Vietnamese file against the European one
| Decree 98 concept | Vietnamese instrument | MDR counterpart | Does it carry across? |
|---|---|---|---|
| Chủ sở hữu thiết bị y tế (product owner) | Article 2(5) | Manufacturer, MDR Art. 2(30) | The concept, not the status |
| Class A or B | Số công bố tiêu chuẩn áp dụng | Class I self-declaration under Art. 52(7) | No; the EU class must be derived from Annex VIII |
| Class C or D | Giấy chứng nhận đăng ký lưu hành | Notified body certificate under Annexes IX–XI | No |
| Tổ chức đứng tên (Article 25) | Vietnamese entity standing in the filing | Authorised representative, MDR Art. 11 | Mirror image, opposite direction |
| ISO 13485 certificate in the dossier | Supporting evidence | Art. 10(9) QMS, audited under Annex IX Chapter I | Content only, never the certificate |
The mandate, the SRN, and what your European customer cannot sign for you
Where the European brand owner is the manufacturer, it holds the Article 11 mandate and the Vietnamese plant appears as a named subcontractor. Where the Vietnamese company exports under its own brand, it needs its own representative, its own SRN and its own registrations, and a customer’s existing arrangements do nothing for it. Medex acts under EUDAMED authorised representative SRN TR-AR-000057550, and is separately registered as a manufacturer, TR-MF-000057496, and as an importer. The person responsible for regulatory compliance is in-house, a partner of the firm, with a deputy. Offices are in Ankara, İstanbul and Gdańsk. Fees are published and class-based, from EUR 1000 a year; scope is described on the EU Authorized Representative service page.
Questions from Vietnamese plants and their European customers
We manufacture to a German company’s specification. Who is the manufacturer under MDR?
Almost certainly the German company, if the device is sold under its name or trade mark and it defines the intended purpose. It then carries Article 10 in full, and your site is named in its submission under Article 10(15). Your obligations flow from the quality agreement rather than directly from the Regulation — but they will be extensive, because your customer has to be able to evidence control over your processes.
Does our Class C circulation registration certificate help with the notified body?
Not as a certificate. The dossier behind it — design verification, biocompatibility, sterilisation and electrical safety testing, clinical data — is genuinely reusable and often covers a substantial share of Annex II. The Vietnamese approval decision itself has no legal effect in the Union.
We already appoint a Vietnamese entity to stand in our filing. Is that the same as an EU representative?
Structurally similar, legally not comparable. The Article 11 representative must be established in a Member State, must accept the mandate in writing, must be the only one for the devices it covers, and under Article 11(5) can be held liable for defective devices jointly and severally with the manufacturer where Article 10 has not been met.
Can we start with one product family?
Yes, and it is usually the right approach. The mandate under Article 11(2) is effective for at least all devices of the same generic device group, so scope it deliberately. Starting narrow lets you build the first Annex II file properly and reuse its structure across the portfolio.
Who registers the device in EUDAMED?
The manufacturer assigns the Basic UDI-DI and submits the device data; the representative has its own registration duty under Article 31 and must verify that the manufacturer has met its obligations under Articles 27 and 29. We run both sides together — see EUDAMED registration — because a mandate without the corresponding actor and device records does not get a product to market.