Vietnam Software, Accessories and Consumables: Article 3.8

Q: Does medical device software need to be registered in Vietnam?

A: It depends on the form, and must be confirmed case by case. Article 3.8 of Decree 98/2021/NĐ-CP provides that the decree’s rules on classification, issue of circulation registration numbers and trading eligibility declarations do not apply to:

• a) software used for medical equipment;
• b) medical devices imported as gifts or complimentary items for individuals or organisations that are not medical institutions, and traded as ordinary goods.

In other words, software used for medical equipment is expressly excluded from those three procedures. How standalone SaMD (Software as a Medical Device) applies is not given a complete pathway in the text and is a grey area in practice.

Q: What should be done about standalone SaMD?

A: Do not decide “file” or “do not file” by inference. GRZAN’s approach is to first apply the Circular 05/2022 classification rules to decide whether the software falls within the device definition and the classification rules. If the conclusion is still unclear, the MAH confirms in writing with IMDA/MOH, and the written reply becomes the basis for action. The reason is simple: choosing the wrong direction risks a later finding of circulation without registration, while written confirmation costs very little.

Q: Do accessories and consumables need separate registration?

A: Decree 98 does not require accessories to be registered with the host device — a dossier submitted with the host that includes accessories or components will be rejected. The manufacturer may, however, choose to register accessories or consumables separately under their own classification.

The practical recommendation is to register critical accessories and consumables separately, for three reasons: (1) a host dossier containing accessories is rejected, which is a hard compliance constraint; (2) separate registration lets customers keep receiving spare parts throughout the host device’s lifecycle; (3) Vietnam applies differential tax treatment to medical devices (medical devices attract a lower VAT rate, non-devices the standard rate; the exact rates follow current Vietnamese tax rules), so separate registration may also be preferable for tax purposes.

Q: How are gift or complimentary devices treated?

A: Point b of Article 3.8 excludes gifts or complimentary items imported for individuals or organisations that are not medical institutions, where they are traded as ordinary goods. Imports for medical institutions — for display, aid or humanitarian assistance — fall under the import licence rules in Article 48 of Decree 98, which is a different matter. For exhibition units and donated equipment, apply Article 48 to decide whether an import licence is needed.

Practical note: settle two questions once, at project start: the form of the software, and whether accessories travel with the host. Lock the software position with written confirmation; split accessories out when the dossier is compiled — the host dossier covers only the host, and accessories are listed as separate SKUs for a registration assessment. If either decision turns out to be wrong after submission, rework is measured in months.

Verification checklist (26 October 2026): (1) Article 3 of Decree 98/2021/NĐ-CP (scope) and Article 3.8 (exclusion of software and gift devices); (2) the Circular 05/2022/TT-BYT classification rules (including the assessment for software); (3) Article 48 of Decree 98/2021/NĐ-CP (when an import licence applies); (4) Article 2.5 of Decree 98/2021/NĐ-CP (product owner); (5) current MOH/IMDA guidance on how software devices are treated.