Vietnam Borderline Products: Combinations, Cosmetics and Software
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: Who regulates drug-device combination products in Vietnam?
A: The answer turns on the principal mode of action. Where the principal action is pharmacological, immunological or metabolic, the product follows the medicinal product route; where it is not, it follows the device route (the definitional framework of Decree 98). The test is the claimed intended use plus the principal mode of action, not the product format or the sales channel.
Q: How are disinfectant products treated?
A: Two categories.
- General disinfectants for humans or the environment: whether they fall within the device definition depends on their intended use;
- Chemicals, insecticides and biocides used solely for disinfecting medical devices: Decree 98 and Article 1(d) of Decree 04/2025 treat these specially. Under the transitional arrangement allowing Class C/D products not on the import licence list to be imported on a classification document, these products are expressly excluded, so that facility cannot be used. Decree 96/2023 also lists “chemicals and products used solely for disinfecting medical devices” separately among its priority processing cases, confirming that this is a separately identified category.
Q: Where is the boundary with cosmetics?
A: Intended use decides. Products intended for cleansing, beautifying or altering appearance are regulated as cosmetics; products claiming diagnostic, therapeutic or disease-relieving uses fall within the device (or medicinal product) definition. The most common overreach in practice is efficacy claims: a product registered as a device but marketed with cosmetic-style wording, which makes the advertising content inconsistent with the declared scope (Article 62).
Q: How are gift and donated devices handled?
A: Article 3.8(b) of Decree 98 excludes devices imported as gifts or donations for individuals or organisations that are not healthcare institutions and traded as ordinary goods from the requirements on classification, circulation numbers and trading eligibility declarations. Note, however, that imports to healthcare institutions for display, aid or humanitarian assistance follow the Article 48 of Decree 98 import licence route, which is a different matter.
Q: What about software products?
A: Article 3.8(a) excludes “software used for medical devices” from the requirements on classification, circulation numbers and trading eligibility declarations; however, how the provision applies to stand-alone SaMD is not clear, and written confirmation from IMDA/MOH must be obtained case by case (see Part 30).
Practical note: do not settle borderline categories by internal discussion. Three steps: (1) make a written determination under the Decree 98 definitions and the Circular 05/2022 rules and keep it on file; (2) where the answer is unclear, obtain written confirmation from the competent authority through the MAH; (3) once the conclusion is in, check that the claims in market materials match it. The third step is the most often skipped, and it is the main source of advertising violations.
Verification checklist (26 October 2026): (1) Decree No. 98/2021/NĐ-CP, Article 2 (definitions), Article 3 (scope) and Article 3.8 (exclusion of software and gift devices); (2) Decree No. 98/2021/NĐ-CP, Article 48 (cases requiring an import licence); (3) Decree No. 04/2025/NĐ-CP, Article 1(d) (exclusion of disinfectants); (4) Decree No. 96/2023/NĐ-CP, Article 147 (priority cases, including chemicals used solely for disinfecting devices); (5) Circular No. 05/2022/TT-BYT, classification rules; (6) Decree 98/2021/NĐ-CP, Article 62 (advertising content must match the declaration).
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.
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