Vietnam lets two device classes skip agency review entirely

Two gates, sorted by class rather than by degree of scrutiny

Decree 98/2021/ND-CP, effective 1 January 2022, overhauled the classification and registration structure Vietnam had run under the older Decree 36/2016, and it sorts devices into the same four-tier ladder most GHTF-derived regimes use — Class A through D, low risk to high. What Decree 98 doesn't do is route all four classes through one authority at varying levels of depth. Class A and Class B devices go through a Declaration of Applied Standards, filed with the Department of Health of the province where the manufacturer or importer is established. Class C and Class D devices go through a Marketing Authorization Registration, reviewed and granted by the Ministry of Health itself, with separate normal, expedited, and emergency procedures depending on the device and the circumstances. A submission plan that treats Vietnam as one registration process with a sliding level of paperwork has missed that the decree splits the country's two lower classes onto a track the two higher classes never touch at all.

A declaration is a different act, not a lighter one

The word “declaration” understates what's actually happening on the Class A and B track. Decree 98 places responsibility for the device's own classification with the organization doing the registering or declaring, not with the provincial Department of Health that receives the filing. The department's role on this track is closer to a public record-keeper than an examiner: it takes in the declaration and the supporting file, and there is no Ministry-level technical review standing between that filing and the device reaching the market. That's a sharper line than most low-risk pathways draw elsewhere — even Thailand's Class 1 Listing still results in a certificate that Thai FDA itself issues against a defined, if lighter, dossier. In Vietnam, a Class A or B device never generates a national regulator's own approval decision at all; the file that matters is the one the applicant built and stands behind.

An indefinite number, applied backward as well as forward

Whichever of the two tracks a device went through, the credential that comes out of it doesn't expire. Decree 98 sets registration numbers and declared codes for all four classes as valid indefinitely, with the narrow exception of registrations granted under the emergency procedure reserved for urgent public-health needs. The decree went further than simply changing the rule going forward: registration numbers already granted under the old Decree 36/2016 regime were carried over as indefinitely valid as well, so a device registered years before the 2022 reform didn't need a fresh filing just to inherit the new rule's benefit. A tracker built to alert on a Vietnam renewal date has nothing to watch for on either track — the one recurring date that matters is whichever change-notification trigger the device's own file conditions require, not a expiry the registration itself no longer carries.

Someone inside Vietnam still has to hold the file

None of this removes the requirement, familiar from Taiwan's domestic-agent structure, that a foreign manufacturer route its filing through a locally established party. Decree 98 calls that party the Authorized Entity: a Vietnamese enterprise, cooperative, or household business that owns the device outright, one authorized by the device's actual owner, or a foreign trader's own representative office in Vietnam. Whichever of the three forms it takes, the Authorized Entity is the party whose name sits on the declaration or registration, and post-market duties run through it rather than through the overseas manufacturer directly. A distribution arrangement that treats a Vietnamese partner as a sales channel, without confirming which of the three Authorized Entity forms it actually holds, has left open exactly the question a provincial Department of Health or the Ministry will ask first if anything goes wrong.

Where this meets the file

A Vietnam registration record needs the track recorded as its own field — Declaration of Applied Standards for Class A and B, Marketing Authorization Registration for Class C and D — alongside the Authorized Entity's name and form, rather than a single “Vietnam: registered” status that can't distinguish a self-declared filing from a Ministry-reviewed one. A cross-border registration tracker built to carry that structure, alongside the launch catalog's other device-registration templates, is previewed there now. If your program has run a device through either of Vietnam's two tracks and found a gap this one misses, the shelf takes that correction directly.