Risk classification

Vietnam classifies medical devices into four risk classes, harmonised with the ASEAN Medical Device Directive and broadly aligned with the GHTF rules: • **Class A — low risk** (e.g., surgical gauze, examination gloves, mechanical wheelchairs, simple bandages). • **Class B — low-to-medium risk** (e.g., hypodermic needles, hearing aids, most diagnostic ultrasound scanners). • **Class C — medium-to-high risk** (e.g., infusion pumps, surgical lasers, most implantable devices, X-ray equipment). • **Class D — high risk** (e.g., heart valves, implantable pacemakers, haemodialysis machines, intra-aortic balloon pumps, most active implants). Classification is performed by the manufacturer or the authorised importer using the classification rules in Circular 05/2022/TT-BYT (which implements Decree 98/2021/NĐ-CP). The classification determines the licensing pathway, the dossier format, applicable post-market obligations, and inspection priority. For products that fall under more than one rule, the highest applicable class is used. In-vitro diagnostic (IVD) devices follow a parallel A–D scheme based on their specific risk rules — see IVD & SaMD. Disputes about classification are reviewed by the Infrastructure and Medical Device Administration (IMDA) under the Ministry of Health, which maintains classification opinions and the authoritative database of classified products.

Core framework: • Decree 98/2021/NĐ-CP — issued 8 November 2021, effective 1 January 2022. Establishes the four-tier classification system; Chapter II covers classification rules. Replaced Decree 36/2016/NĐ-CP and Decree 169/2018/NĐ-CP. • Decree 07/2023/NĐ-CP — issued 3 March 2023. Amends Decree 98/2021; transitional rules for legacy registration numbers and import permits. • Circular 05/2022/TT-BYT — issued 1 August 2022. Detailed classification rules implementing Decree 98/2021. Reference standards: • ASEAN Medical Device Directive (AMDD) — harmonised classification principles; Vietnam aligns its rules with AMDD for ASEAN mutual recognition. • Global Harmonization Task Force (GHTF) classification guidance — underlying reference for the AMDD scheme. • IMDRF (International Medical Device Regulators Forum) Software as a Medical Device guidance — referenced for SaMD classification (see IVD & SaMD).

2024 — Mandatory ASEAN CSDT for Class C and D: From 1 January 2024, dossiers for Class C and D devices must follow the ASEAN Common Submission Dossier Template (CSDT). This harmonisation simplifies multi-market submissions but requires upfront restructuring of legacy dossiers. 2023 — Decree 07/2023/NĐ-CP transitional fixes: Issued during the post-pandemic medical-device shortage. Auto-extended import permits issued 2018–2021 and IVD registration numbers issued 2014–2019 to 31 December 2024 to avoid a wave of relicensing during supply pressure. 2022 — Circular 05/2022/TT-BYT: Brought the operational classification rules in line with Decree 98/2021/NĐ-CP and updated the rule set against the latest ASEAN AMDD revisions.