One Oncology Assay System, Several Regulatory Objects in Vietnam

A manufacturer of quantitative oncology diagnostics asked us to bring its tumor-marker immunoassay system into Vietnam. The system was ordinary in the way successful laboratory products usually are: assay reagents supplied with matching calibrators, a set of quality-control materials ordered alongside them, a few ancillary consumables, and an analyzer platform the target laboratories already ran. The commercial plan was detailed. The regulatory plan was one line in the launch deck — register the assay.

Two central authorizations now stand in force under our Vietnamese entity's name for that system: one covering the assay reagents and calibrators, the other covering the matching quality-control materials. The distance between the one-line plan and those two records is what this case is about.

The plan counted products; Vietnam counts regulatory objects

The manufacturer's catalog described one product. Its regulatory budget, its distributor conversations and its launch date were all built on that count. Vietnam does not register catalogs. It registers devices under defined grouping categories — family, system, set, IVD test kit or IVD cluster — and each category has its own conditions. A family requires a common intended purpose and risk class; a system or IVD test kit can combine compatible components used together for a common purpose; an IVD cluster follows its own class, methodology and category criteria. The distinctions matter more than the commercial word "system," as our Vietnam classification and grouping guide explains.

So the first deliverable was not a dossier. It was an inventory: what, precisely, was going to be placed on the Vietnamese market. Written out, "the assay" resolved into the reagents and their calibrators, the control materials as a separately ordered product with its own catalog numbers and lots, ancillary items used to run the workflow, and an instrument the manufacturer did not own or supply. That list, and not the product brochure, determined how many dossiers existed, which authorities would receive them, and what the launch sequence had to look like.

Settling class before the submission architecture froze

Vietnam does not use an appointed third-party classifier. Under Decree 98/2021/ND-CP as amended, the registration number holder performs the classification, publishes it and answers for it. That matters more than it sounds: where a classification understates a device's risk level, the decree does not simply ask for a corrected filing. It contemplates stopping placement on the market, recalling product cleared under the wrong result, reporting cleared quantities to customs, and applying again with the correct class.

The manufacturer's team knew the classification rules well enough to be caught by them. Calibrators intended for use with an IVD reagent take the class of that reagent, and control materials with assigned values do the same — so, the reasoning went, calibrators and controls were already covered by whatever the assay was. The first half of that is correct and is what Vietnam's AMDD-aligned rules in Circular 05/2022 provide. The second half confuses a classification outcome with a filing outcome. Sharing a class does not put two products inside one application; it only means the same door applies to both.

We worked the rules object by object and wrote the rationale down for each one, including the ancillary items that landed in the lower classes. Only then was the submission architecture — how many files, in what shape, to whom — allowed to freeze.

Two doors, two authorities, one program

The classification map split the engagement across two authority levels. Lower-class items travel as declarations of applied standards filed with the provincial Department of Health. The assay reagents and calibrators, and the control materials, each required the Ministry of Health's central registration procedure for imported Class C/D in vitro diagnostics, built on an ASEAN CSDT technical file. Two dossier formats, two authorities, two administrative rhythms, inside one program. Our Vietnam regulations overview sets out both routes in full.

The client's instinct was to start with the provincial declarations because they were the quickest to assemble, and to let the central files follow once the local team had settled in. We argued the opposite order. Nothing in the provincial set generates revenue on its own — a laboratory cannot run a tumor-marker assay on wash buffer — and the central route is the one that has historically absorbed the time, to the point that the government repeatedly extended transitional import permissions while the central queue caught up, first through Decree 07/2023 and again through Decree 04/2025. The central dossiers led the schedule; the provincial declarations were timed to land with them.

Why the controls became a separate authorization

The manufacturer assumed that anything used with the assay could sit inside the assay file. Vietnam's grouping guidance does allow controls and calibrators inside an IVD test kit when the components are intended to be used together for a specific purpose and the product is presented as a qualifying kit or system. A control is therefore not automatically a separate registration merely because its immediate job is quality control.

The boundary in this program came from the actual product architecture. The reagents and calibrators were supplied and labelled as one assay object. The quality-control materials were a separately ordered product with their own name, catalog numbers, lots, shelf life and assigned-value documentation; the labeling did not present them as constituent items of one registered kit. We tested both grouping paths. Keeping the controls inside the assay object would have required the commercial and labeling structure to become something it was not. A separate central authorization matched how the product was supplied and maintained — which is how the two records read today.

Recognizing that early changed the work rather than merely adding to it: two product names to reconcile, two sets of labeling, two dossiers to keep internally consistent, and two lifecycles to own. Discovering it during submission would have meant rebuilding the architecture with the launch date already public.

Rebuilding the evidence chain the dossier actually asks for

The manufacturer's technical documentation was strong where its home market had pressed hardest: precision, linearity and measuring interval, limits of detection and quantitation, interference, specimen handling. Two gaps mattered here.

First, calibration traceability. Vietnam's essential-principles set carries the requirement that where a device's performance depends on calibrators or control materials, the traceability of the values assigned to them is assured through the quality management system. The file described the assay's calibrators as traceable to an internal master lot and stopped there. We asked for the chain itself: what the assigned values are anchored to, how each new lot is value-assigned and verified against the previous one, and who inside the quality system owns that procedure.

Second, the controls had been treated as production material rather than as a product with a dossier. Their lot-specific value sheets lived in manufacturing records, and their stability evidence had never been assembled in the form a CSDT expects — real-time and in-use claims stated, supported and matched to the labeled storage conditions. Both gaps were the manufacturer's to close, and closing them was the bulk of the technical work. Vietnam reads the central file against a fixed template, with the CSDT evaluation forming part of the application itself, so internal consistency between the two dossiers was a requirement rather than a matter of style.

The certificate question, asked object by object

Vietnam's central dossier list names in vitro diagnostic reagents, reference substances and control materials specifically: they call for a quality-assessment certificate issued by a competent Vietnamese agency unless the product falls within an exemption, and Circular 05/2022 supplements those exemptions — for example where the product holds a certificate of free sale from one of the foreign authorities named there.

The manufacturer had a certificate of free sale and assumed it covered everything it shipped. It named the assay product line. Exemptions of this kind are read product by product, so each object's certificate coverage had to be checked against the exemption text, and the certificates and their translations organized to match what was actually being filed.

The same discipline applied to the faster option. Vietnam's expedited procedure exists inside the Class C/D registration route — it is not a way to accelerate a provincial declaration — and eligibility depends on the specific product's approval in a recognized reference market. It is assessed for each object, never granted to a family because one member qualifies.

Vietnamese labeling for vials whose values change with every lot

Vietnamese labels must be in place before circulation and the instructions for use must be in Vietnamese, carrying the authorization details as our Vietnam labeling guide describes. For a quantitative system, the practical difficulty is small containers and moving numbers: calibrator and control vials carry lot-specific assigned values that change with every production lot.

We built the labeling package so that the per-lot value documentation is handled as production documentation rather than as a change to the authorized record, and separated the change catalog in advance — which revisions are self-notified within the decree's ten-working-day window, and which ones are substantive enough to require a fresh declaration or registration. A manufacturer that has not drawn that line before launch tends to draw it in the middle of a lot release.

What the laboratory needed on day one

An authorization for reagents alone would have been a lawful result and an unusable one. A laboratory cannot bring a quantitative oncology assay into routine service without the controls its quality policy requires, and generic controls are not interchangeable with materials whose values are matched to the assay. The two central files were therefore run as one workstream: one evidence map, one naming convention, one submission architecture, one change-control plan, with the provincial declarations sequenced so that no part of the workflow arrived without the parts it depends on.

Both central authorizations are in force, held by our Vietnamese entity, and the system can be sold as a system.

Running two records as one

Authorizations under Decree 98 generally have no fixed term. That removes a renewal calendar and replaces it with standing duties, which our Vietnam post-market guide covers in detail: vigilance obligations that distinguish a potential serious risk from an actual incident, change notification, Vietnamese labeling and instructions kept aligned with the authorized product, and traceability records retained by the holder — which in a market with no full national UDI system means batch discipline carries the traceability.

Two records for one laboratory system add one rule to all of that. Every proposed change is assessed against both files before it is made, because a revision that quietly moves the reagent record away from the control record leaves the manufacturer holding two authorizations that no longer describe the same system.

If your system looks like this one

Start from the laboratory bench rather than the price list: name every object you intend to place on the market, classify each one against the current Vietnamese rules, and only then decide how many applications exist and which authority receives them. Treat calibrators and control materials as evidence-bearing products, not packaging. And sequence the filings around what a laboratory actually needs to run the test on day one.

We do this work as the local registration holder, not as a filing agent — see our IVD practice and the Vietnam market page for how the engagement is structured, or talk to our team about your own assay system.