What Counts as a Medical Device in Vietnam: Definition and Software
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: How does Vietnam define “medical device”?
A: Decree 98/2021 keeps the familiar definition framework: an instrument intended for human use for the prevention, diagnosis, treatment or alleviation of disease, for the examination, replacement or correction of an injury, for the support of a physiological process, for life support, for the control of conception or for disinfection, and whose principal mode of action is not pharmacological, immunological or metabolic. It covers instruments, apparatus, materials, reagents and software. The two tests are the intended-use claim and principal mode of action.
Q: What is the “Product Owner”, and why does it matter?
A: Article 2.5 of Decree 98/2021 defines the product owner as an organisation or individual that (a) supplies the device under its own name, or under a trademark, design, trade name or other name that it owns or controls; and (b) is responsible for the design, manufacture, assembly, processing, labelling, packaging or repair of the device, or determines the device’s intended use.
The key point: the product owner is not the holder of the circulation number. The product owner may authorise another party to apply for and hold the circulation number, or to act as the declarant of the Declaration of Applicable Standards. This is the legal basis of Vietnam’s MAH system: the overseas manufacturer, as product owner, authorises a Vietnamese MAH to hold the registration.
Q: How is software treated?
A: This is the most frequently misread point in the Vietnamese system. Article 3.8 of Decree 98/2021 provides that the rules on classification, issue of circulation registration numbers and trading eligibility declarations do not apply to: (a) software used in or for medical devices; and (b) medical devices imported as gifts or donations for individuals or organisations that are not medical facilities and traded as ordinary goods.
In other words, software embedded in or used for a medical device is expressly excluded from those three procedures. The text gives no complete route for standalone SaMD. GRZAN’s practice is to confirm the specific form of the product in writing with IMDA or the partner MAH before filing, rather than inferring whether to file or not. The cost of choosing wrongly is a later finding of unlicensed circulation.
Q: Where are the three common boundaries drawn?
A: (1) versus medicinal products: where the principal mode of action is pharmacological, immunological or metabolic, the product is regulated as a medicine; (2) versus cosmetics: products intended for cleansing, beautifying or changing appearance are regulated as cosmetics; (3) versus plain disinfectants: chemicals, insecticides and biocides used only to disinfect medical devices have separate rules in the import licence list (Article 1(d) of Decree 04/2025 expressly excludes them from the “import-licence-free” category).
Practical note: do not settle a classification dispute by internal discussion. There are two routes: commission a body with classification credentials in Vietnam to issue a classification conclusion and publish it on the MOH portal, or ask the partner MAH for a comparison based on precedents for similar products. Once classification is wrong, everything downstream is wrong too — the class itself, the depth of documentation, the fee band and the review timeline — and rework costs far more than confirming the position early.
Verification checklist (26 October 2026): (1) Articles 2.5 (definition of product owner), 3 (scope and exclusions) and 3.8 (exclusion of software and gift devices) of Decree 98/2021/NĐ-CP; (2) the classification rules in Circular 05/2022/TT-BYT; (3) Article 1(d) of Decree 04/2025/NĐ-CP (disinfectant exclusion); (4) the classification publication function on the MOH device portal.
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
About GRZAN
GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.
GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.
Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.
What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.
Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.
Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.
Take your devices global with GRZAN
We work with manufacturers worldwide to open new markets with a clear regulatory pathway.
Contact us