A medical device dossier for Vietnam starts with one decision that shapes everything after it: which of four risk classes the product falls into. Get the class wrong and the wrong procedure follows it — a device filed as a low-risk declaration when it actually needs full registration cannot legally circulate, however complete the paperwork otherwise looks.
The four classes
Decree 98/2021/ND-CP sorts medical devices into four classes, A to D, by the level of risk associated with their intended use — not by price, complexity or how the manufacturer markets the product at home.
| Class | Risk level | Typical procedure |
|---|---|---|
| A | Low risk | Declaration of applicable standards (classification result published; no registration number needed) |
| B | Medium-low risk | Registration for circulation |
| C | Medium-high risk | Registration for circulation |
| D | High risk | Registration for circulation |
Checked against the published text on 15 September 2026.
Classification runs on rules set out in the decree and its guiding circular, applied to the device’s intended purpose, its duration of contact with the body, its invasiveness, and whether it depends on a power source — the same physical device can sit in a different class depending on what it is labelled and marketed to do. A device with more than one plausible classification is classified by its principal intended use, and the classification result has to be publicly registered before the device can be declared or registered for circulation.
💬 Not sure which class your device falls into before you commit to a registration timeline? Send us the product’s intended use and technical file and we will work through the classification with you — contact Sunsho Trade.
Declaration versus registration
Class A devices go through a declaration of applicable standards — a notification the manufacturer or importer publishes, with no pre-circulation certificate to wait for — while classes B, C and D require a registration for circulation issued by the competent authority before the device may be sold.
The declaration route for Class A mirrors, in structure if not in the underlying law, how an ordinary imported food is self-declared: publish the classification result and the declaration, and the device may circulate without a separate approval step, provided the classification itself was correctly filed and the dossier’s Vietnamese-language content is in order. As with a food self-declaration, publishing the classification result is the step that makes the product legal to sell — a completed form sitting unpublished in a compliance file does not satisfy the requirement.
Once a device is on the market, its Vietnamese label carries its own obligations, running on the general Decree 37/2026/ND-CP checklist covered in the Vietnam supplementary label checklist, with group-specific content for medical devices added on top of the general fields. A correctly classified and registered device with an incomplete Vietnamese label is still not legally on the shelf — the two approvals are independent of each other, and both have to be current at the same time.
The registration route for Classes B, C and D is materially heavier. It requires a technical dossier, evidence supporting the device’s safety and performance for its intended use, and — for imported devices — a Free Sale Certificate or equivalent from the authority of the country of manufacture. Nothing in Classes B, C or D may be sold before the registration number is issued, so the timeline for these classes has to be built into the commercial plan rather than assumed to run in parallel with the first shipment.
💬 Registering a Class B, C or D device and building the import timeline around it? Sunsho Trade coordinates the classification, the registration dossier and the import together — see our Selling into Vietnam service.
Who holds the registration
The classification result and the registration for circulation are both filed by a party established in Vietnam, and — as with cosmetic and food declarations — the registration is issued in that party’s name rather than the foreign manufacturer’s.
This is the same structural rule that runs through Vietnamese product law generally: a Vietnam-based importer, distributor, or authorised representative office files and holds the registration, and a change of that party generally means the incoming party files its own registration rather than inheriting the old one. Settle in the distribution or representation agreement who is named as the registration holder, and what happens to it if the relationship ends — the same point covered for trading structures generally in who can legally import your product into Vietnam.
Import licensing and the transitional rules
Decree 98/2021/ND-CP, as amended, has moved medical device import away from a standalone import licence and toward the registration number itself serving as the basis for customs clearance — but the amendments have repeatedly extended transitional deadlines for older registrations and licences, so the current cut-off dates need checking against the text in force on the day you import, not against an earlier amendment.
Decree 98/2021/ND-CP has been amended more than once — by Decree 07/2023/ND-CP and again by Decree 04/2025/ND-CP — with several of those amendments specifically extending the validity of transitional import licences and older registration numbers rather than changing the classification or registration procedure itself. Circular 44/2025/TT-BYT, issued in November 2025, decentralised some administrative procedures in this area to provincial-level authorities. Because the transitional deadlines have moved more than once, confirm the cut-off date that applies to your specific registration or licence type against the current consolidated text before relying on an earlier announcement — a deadline correct six months ago may since have been extended or allowed to lapse.
💬 Holding an older import licence or registration number and unsure if it is still valid? Ask Sunsho Trade to check it against the current transitional rules before your next shipment.
What a classification file actually needs
A classification submission is built on the device’s technical documentation and its intended purpose as stated by the manufacturer, cross-checked against the classification rules in the decree’s guiding circular — not on a self-assessment against a home-market category.
| Element | What it establishes |
|---|---|
| Intended use statement | The basis for which classification rule applies — the single most consequential line in the file |
| Technical description and specifications | Invasiveness, duration of contact, power dependency, and other factors the classification rules turn on |
| Manufacturer’s own classification (if any) | A reference point, not binding on the Vietnamese classification outcome |
| Supporting technical or clinical documentation | Evidence for the registration dossier once the class is confirmed, heavier for Classes C and D |
A device that is Class I or II under a different jurisdiction’s rules (the EU MDR classes, for instance) does not automatically map to the equivalent Vietnamese class, because the underlying classification rules are not identical in every respect. Treat a foreign classification as a starting reference for the technical file, not as the answer to file under in Vietnam.
The classification result itself has to be made public before it can be relied on — it is entered on the Ministry of Health’s electronic information portal, and it is that published entry customs and market inspectors check against the declared class, not the manufacturer’s internal paperwork. A device imported and sold against a classification that was decided internally but never actually published on the portal is in the same position as a food self-declaration that was drafted but never posted: the substance of the compliance work was done, but the step that makes it effective was not, and that gap only surfaces at an inspection rather than at the point of filing.
Frequently asked questions
1. Does a Class A medical device need a registration number before it can be sold in Vietnam?
No. Class A devices go through a declaration of applicable standards rather than a registration for circulation, and may be sold once the declaration and classification result are published — there is no certificate to wait for on this route.
2. Who decides which class a device falls into — the manufacturer or a Vietnamese authority?
The classification is carried out under the rules in Decree 98/2021/ND-CP and its guiding circular, applied to the device’s intended use as stated in its own technical file. A manufacturer’s classification under another jurisdiction’s rules is a reference point, not the Vietnamese classification.
3. Can a Class B, C or D device be imported before the registration number is issued?
No. Classes B, C and D require the registration for circulation to be issued before the device may be sold, and the registration is also generally the basis customs clearance relies on for these classes.
4. Is an older Vietnamese medical device import licence still valid?
It depends on the transitional deadline that applies to that specific licence or registration type, since Decree 98/2021/ND-CP has been amended more than once to adjust these deadlines. Confirm the current cut-off against the consolidated text in force rather than an earlier announcement.
5. If we change distributor, does the device’s registration for circulation move with it?
No. The registration is issued to the party that filed it — usually the Vietnam-based importer, distributor or authorised representative. A new party generally files its own registration, so settle in the agreement who holds it and what happens on termination.
Sources: Decree 98/2021/ND-CP, Decree 07/2023/ND-CP and Decree 04/2025/ND-CP (thuvienphapluat.vn, vanban.chinhphu.vn); Circular 44/2025/TT-BYT (Ministry of Health). Checked on 25 September 2026.