Vietnam IVD Registration: Classification and Biological Products
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: How are IVDs classified in Vietnam?
A: Circular 05/2022/TT-BYT adds 7 rules specific to in vitro diagnostic devices to the 16 general rules. IVD risk is not judged on the same logic as therapeutic devices; the rules consider the purpose of the test, the risk attaching to the analyte and the consequences of a wrong result. Neither “all IVDs are low risk” nor “all IVDs are Class C” is therefore a valid generalisation. Each product must be assessed against the IVD-specific rules.
Q: What special historical arrangement applied to IVD biological products?
A: There was one, and it has expired. Article 1(c) of Decree 04/2025 (amending Article 76(3)(c) of Decree 98) provided that circulation registration numbers for in vitro diagnostic biological products issued between 1 January 2014 and 31 December 2019 remained valid until 30 June 2025 (previously 31 December 2024). Import licences for in vitro diagnostic biological products issued between 1 January 2018 and 31 December 2021 were also extended to 30 June 2025, with no import quantity limit.
These arrangements likewise ended on 30 June 2025. A holder of such an old number that imported or sold on it after 1 July 2025 was engaged in unlicensed circulation.
Q: What else should be watched in an IVD filing?
A: Three points. (1) The classification rules differ (see above). (2) Some IVDs fall within the biological products category, and their transitional rules historically ran out of step with those for ordinary devices, so old certificates must be checked period by period. (3) The clinical investigation report certificate introduced by Decree 96/2023 (in force for Class C/D from 1 January 2026) directly affects IVDs that need local clinical data, so scheduling must start early.
Q: How is the boundary between IVDs and other product categories drawn?
A: By intended use. A product used to test human samples outside the body in order to provide diagnostic information is an IVD. Products for environmental, food or veterinary testing are not IVDs within the device definition (some fall under other authorities). Products that also have a therapeutic function are judged by their principal mode of action.
Practical note: the most common error for IVD manufacturers in Vietnam is to apply the EU IVDR class directly. IVDR Classes A/B/C/D share their names with the Vietnamese classes but not their content: an IVDR Class C product is not necessarily Vietnamese Class C. Reclassify under the IVD-specific rules of Circular 05/2022 and record the reasoning in the filing.
Verification checklist (26 October 2026): (1) the IVD-specific classification rules in Circular No. 05/2022/TT-BYT; (2) Article 76(2) and (3) of Decree 98/2021/NĐ-CP; (3) Article 1(2) and (3) of Decree 04/2025/NĐ-CP (import licences and IVD biological product circulation numbers extended to 30 June 2025); (4) Article 147(19) of Decree 96/2023/NĐ-CP (clinical investigation report certificate, in force 1 January 2026).
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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