IVD & Software as a Medical Device

In-vitro diagnostic devices (IVDs) and software as a medical device (SaMD) are both regulated under Decree 98/2021/NĐ-CP — but with different levels of operational maturity. IVDs: • Defined as reagents, calibration materials, control materials, test kits, instruments, and software intended to be used in vitro for the examination of specimens (including blood and tissue) for the purpose of diagnosis, monitoring, screening, or treatment selection. • Classified into A, B, C, D using IVD-specific risk rules in Circular 05/2022/TT-BYT, with criteria based on disease severity, individual vs public-health impact, and self-test vs lab-test use. • Registration follows the same MAC pathway as other devices. IVD registration numbers issued 2014–2019 were auto-extended to 31 December 2024 by Decree 07/2023. • Lab-performance evidence and analytical/clinical validation are core parts of the IVD dossier. Software as a Medical Device (SaMD): • Vietnam regulates SaMD as a medical device when the software meets the medical-device definition (intended for diagnosis, monitoring, prevention, or treatment of disease). • Risk classification follows the same A–D rules; the IMDRF SaMD classification framework is a useful reference but is not directly codified in Vietnamese rules. • **Gap to note:** as of 2026, neither Decree 98/2021 nor Circular 05/2022 provides SaMD-specific operational guidance on topics like software change control, cybersecurity, AI/ML model updates, or real-world performance monitoring. Sponsors of SaMD products often submit dossiers informed by IMDRF, FDA, and EU MDR guidance and respond iteratively to IMDA review questions. • Standalone consumer wellness apps without a medical purpose are not regulated as medical devices.

Core framework: • Decree 98/2021/NĐ-CP — applies equally to IVDs and SaMD that meet the medical-device definition. • Decree 07/2023/NĐ-CP — transitional extension of legacy IVD registration numbers (2014–2019 numbers extended to 31 December 2024). • Circular 05/2022/TT-BYT — IVD-specific risk-classification rules; general rules covering SaMD. IVD-specific (reference): • ASEAN harmonised classification principles for IVDs. • Codex / WHO guidelines on lab-test performance and validation (referenced in dossier evaluation). SaMD reference (non-binding in Vietnam, frequently used in dossiers): • IMDRF SaMD framework documents — definition, key definitions, application of QMS, application of clinical evaluation. • US FDA Digital Health guidance. • EU MDR (Regulation 2017/745) — for products also placed on the EU market. Note: SaMD-specific Vietnamese guidance has been on the IMDA workplan in industry consultations. Sponsors should monitor for new circulars.

2024 — IVD registration-number transition deadline: Legacy IVD registration numbers issued 2014–2019 expired on 31 December 2024 unless re-registered under Decree 98/2021. Holders that missed the deadline have had to file new dossiers. Ongoing — Industry consultation on SaMD: IMDA and MOH have engaged industry on the need for SaMD-specific guidance, covering software change-control, AI/ML model lifecycle, and cybersecurity. As of 2026 no formal circular has been issued. 2023 — IVD shortage relief in Decree 07/2023: During the post-pandemic supply pressure, Decree 07/2023 explicitly extended IVD numbers and import permits to allow continuity of laboratory diagnostic services.