Medical device IFU into Vietnamese: the regulatory checklist

💡 Vietnam's Decree 37/2026/ND-CP and Circular 05/2022/TT-BYT require all mandatory label info and IFU in Vietnamese for every medical device sold in Vietnam. Lay-use devices need a printed IFU; professional devices may use an e-IFU with QR code. Terminology must match official MoH and Vietnam Pharmacopoeia standards - a mismatch is the most common dossier review comment.

Why is a Vietnamese-language IFU non-negotiable for Vietnam market entry?

Vietnam's primary medical device regulation, Decree 98/2021/ND-CP (as amended by Decrees 07/2023 and 04/2025), requires that all devices circulated on the Vietnamese market comply with domestic labeling rules. Decree 37/2026/ND-CP, effective 23 January 2026, replaced Decrees 43/2017 and 111/2021 to set the current mandatory label content framework. The requirement is unambiguous: all mandatory information on medical device labels must be written in Vietnamese. A device whose label or IFU is entirely in English or another language cannot legally enter Vietnamese distribution channels.

The only permitted exceptions are: international or scientific names with no established Vietnamese equivalent, chemical and structural formulas, and the names and addresses of foreign manufacturing entities. All other content, especially the intended use, warnings, contraindications, and IFU, must appear in Vietnamese before the device reaches an end user.

Which device class determines how much translation work you need?

Vietnam classifies medical devices into four risk-based classes under Decree 98/2021: Class A (lowest risk) through Class D (highest risk, e.g. implantable devices). The class determines both the registration route and the scrutiny applied to documentation.

Class	Risk level	Registration route	Typical timeline
A	Low	Provincial Department of Health notification	3-5 business days
B	Low to moderate	Provincial notification (with more documentation)	3-5 business days
C	Moderate to high	MOH/IMDA Marketing Authorization Certificate (MAC)	10 days fast-track / 40-45 days standard
D	High (implantable, life-supporting)	MOH/IMDA MAC - full technical dossier	40-45 business days

For Class C and D devices, the translation quality of the IFU and label is directly reviewed as part of the technical dossier. Terminology mismatches with the Vietnam Pharmacopoeia or official MoH terminology lists are one of the most common reasons for review comments.

What must be in Vietnamese on the label and in the IFU?

Decree 37/2026 specifies the following mandatory Vietnamese-language elements. Use this checklist before submission to the IMDA portal:

• Device name: must appear in the most prominent position, largest font on the label
• Circulation or import license number (registration number format per device class)
• Manufacturer name and full address (domestic); manufacturer plus registration holder for imports
• Country of origin: full name in Vietnamese, no abbreviations
• Lot or serial number
• Manufacturing date (NSX) and expiry date (HSD) in day/month/year format, using separators (periods, slashes, hyphens, or spaces)
• Intended use: must match the registered indication verbatim
• Warnings and contraindications (may reference accompanying documentation if space is limited)
• Storage conditions and use environment
• Instructions for use or a clear reference to where the IFU can be accessed

Imported devices with a foreign-language original label may apply a supplementary label after customs clearance, covering every mandatory item not already in Vietnamese, without obscuring or altering the original label.

IFU format under Circular 05/2022/TT-BYT: Lay-use devices (patients, general consumers) require a printed Vietnamese IFU - electronic-only IFU is not permitted. Professional-use devices (clinical settings) may use an electronic IFU when it is freely accessible online without login, downloadable and printable, version-matched to the device on market, and the label carries a URL or QR code reference. A bilingual EN/VI IFU is permitted alongside Vietnamese for professional devices.

What Vietnamese medical terminology pitfalls can sink your dossier?

Vietnamese medical terminology is built on three layers: Sino-Vietnamese compounds borrowed from classical Chinese medicine, French loanwords from the colonial period, and modern scientific terms adapted from English. A translator unfamiliar with this hierarchy can produce text that is linguistically correct but does not match the terms the Vietnam Ministry of Health uses in official documents.

The most common review-comment triggers:

• Using generic instead of MoH standard terms. "Huong dan su dung" (IFU), "chong chi dinh" (contraindication), "tac dung khong mong muon" (adverse effect) are the MoH-standardized forms. A synonym or informal equivalent creates a technical mismatch.
• Tone-diacritic errors. Vietnamese has six tones written as diacritics. A missing or wrong mark produces a different word with no spell-checker warning.
• Calquing English compound terms directly. Vietnamese technical compounds are not direct calques of English. They must be verified against official terminology lists, not assembled word-by-word from a dictionary.

Back-translation review: the usability engineering standard ISO 62366 recommends a back-translation check on IFUs destined for non-source-language markets. Workflow: translate EN to VI, then have a second independent translator render VI to EN without seeing the source, then compare the two English versions. Divergences flag translation accuracy issues before they reach the regulator.

What can you handle in-house, and when does a native medical translator save money?

Label elements that are formulaic, such as lot numbers, NSX/HSD date fields, manufacturing address, and country of origin, can be templated and adapted in-house once the Vietnamese format is established. For Class A devices with short, standardized labels, a well-prepared internal checklist is often sufficient for the supplementary label.

A native Vietnamese medical translator becomes cost-effective at the following points:

• Class C/D dossier preparation: MoH reviewers read the Vietnamese IFU closely. A single terminology mismatch delays the 40-45-day clock and requires a re-submission round. The cost of one revision cycle almost always exceeds the cost of professional translation upfront.
• First-entry terminology setup: Building a master glossary aligned to the Vietnam Pharmacopoeia and MoH terminology for your device category. This asset then speeds every future product registration or label update.
• Lay-use IFU for any class: These reach patients without professional mediation. Readability, correct honorifics, and safety-critical diacritic accuracy all require native medical expertise.
• Label changes triggered by Decree 37/2026: Devices imported before 23 January 2026 are exempt, but any new batch or label update now falls under the new decree. This is a natural trigger for a professional review of the entire Vietnamese label package.

For Vietnamese medical translation, the decision rule is clear: if the document reaches a regulator or a patient, professional native review is not optional - it is the one step that prevents a costly re-submission or a patient safety risk.

FAQ

Does every medical device sold in Vietnam need a Vietnamese IFU?

Yes. Decree 98/2021/ND-CP and Circular 05/2022/TT-BYT require Vietnamese IFU for all medical devices sold in Vietnam. Lay-use devices must provide a printed Vietnamese IFU. Professional-use devices may use an electronic IFU if accessibility requirements are met. There is no class-based exemption from the Vietnamese language requirement.

Can I use a supplementary label rather than reprinting the entire label in Vietnamese?

Yes. Imports may attach a Vietnamese supplementary label after customs clearance. This label must cover every mandatory element that is not already in Vietnamese on the original. It must not obscure or physically alter the original label, and must be consistent with the registered product documentation.

Which registration body receives the Vietnamese IFU?

Since January 2025, the Infrastructure and Medical Device Administration (IMDA) under the Ministry of Health handles all Class B/C/D registrations via the online portal at imda.moh.gov.vn. Class A devices are declared at the provincial level. All submissions for Class C/D require the full Vietnamese label and IFU as part of the technical dossier.

Is machine translation acceptable for a medical device IFU in Vietnam?

No. Machine translation output cannot be submitted as a Vietnamese IFU without expert review. The Vietnam MoH expects terminology aligned to the Vietnam Pharmacopoeia and official MoH lists. MT engines frequently produce generic synonyms that do not match these official terms, which is the most common reason for review comments. MT can assist as a first draft for formulaic label elements (lot numbers, date fields, addresses), but the IFU and safety-critical content require native medical translation.

Does Decree 37/2026 replace Decree 98/2021 for medical devices?

No. Decree 37/2026/ND-CP updates the general product labeling framework (replacing Decrees 43/2017 and 111/2021 on labeling). Decree 98/2021/ND-CP (amended by Decrees 07/2023 and 04/2025) remains the primary law governing medical device registration and management in Vietnam. The two decrees work together: Decree 37/2026 covers label format and content; Decree 98/2021 governs the registration and market authorization process.

Official Sources

• IMDA: Infrastructure and Medical Device Administration - Vietnam Ministry of Health - Official portal for all Class B/C/D medical device registrations in Vietnam. Verified October 2026.
• Medibase: Medical Device Labelling in Vietnam - Detailed breakdown of Circular 05/2022 IFU requirements, e-IFU rules, supplementary label process. Verified October 2026.
• Med Device Guide: Vietnam Medical Device Registration Guide 2026 - Classification timeline, IMDA portal, 2025-2026 regulatory updates including 50% fee reduction. Verified October 2026.
• QualTechs: Vietnam Decree 37/2026 Labeling Requirements - Mandatory label content, date formats, minimum font size 0.9 mm, supplementary label rules. Verified October 2026.