Vietnam Clinical Evidence: Decree 96/2023 Rules From January 2026
Updated: 2026-11-05 · GRZAN Regulatory Team · Verification date 2026-10-20
Q: Does registration in Vietnam require clinical data?
A: Usually yes for invasive or implantable Class C/D devices. In addition, Article 147.19 of Decree 96/2023/NĐ-CP added a requirement to Article 30 of Decree 98: the registration dossier for Class C/D devices must include a Certificate of Clinical Test Results issued by a competent authority. The requirement takes effect on 1 January 2026.
Q: Is this a new requirement?
A: Yes. It was introduced by Decree 96/2023 (30 December 2023) through the package amendment in Article 147, with an effective date of 1 January 2026 — an arrangement that publishes early and applies later. Class C/D dossiers filed earlier follow the old requirements; those submitted on or after 1 January 2026 must meet the new one.
Q: What else did the same decree change?
A: Article 147.8 to 147.18 of Decree 96/2023 rewrote Chapter IV, “Clinical study on medical devices” of Decree 98, covering the phases of clinical study, requirements for the investigational device, requirements for the study site, the clinical study dossier, the approval procedure, the procedure for approving changes, the procedure for approving results, and the responsibilities of the parties. In other words, Vietnam’s clinical study regime was systematically restructured under 96/2023.
Q: Which products are most affected?
A: Invasive and implantable Class C/D devices (cardiovascular interventional devices, orthopaedic implants, active implantable devices, some high-risk IVDs). These products already needed clinical evidence; the certificate of clinical test results issued by a competent authority now adds a formal requirement, meaning that an in-house or foreign clinical report alone may not be enough: a confirmatory document from the Vietnamese competent authority is also required.
Q: How should manufacturers respond?
A: Three routes. (1) Plan early — build the Vietnamese clinical confirmation procedure into the project plan; it is not an action that can be added at the end. (2) Assess the expedited pathway — Class C/D devices with a reference country approval can use it, which relieves some of the time pressure. (3) Confirm case by case — whether the requirement applies, and what form of evidence is needed, should be confirmed in writing with IMDA through the MAH for each product.
Practical note: schedule around 1 January 2026 as the dividing line for Class C/D projects in Vietnam. For products with a complete dossier in 2025, assess whether it is worth filing before the threshold applies; for projects starting after 2026, build budgets and timelines on a schedule that includes the clinical confirmation procedure. Making this judgement six months earlier can save a year of waiting.
Verification checklist (26 October 2026): (1) Article 147.8 to 147.18 of Decree No. 96/2023/NĐ-CP (30 December 2023) (Chapter IV, clinical study) and Article 147.19 (the certificate of clinical test results added to Article 30, effective 1 January 2026); (2) the current text of Article 30 of Decree 98/2021/NĐ-CP; (3) Articles 32 and 32a of Decree 98/2021/NĐ-CP (review and expedited pathway); (4) current MOH/IMDA guidance on how the clinical requirements are applied.
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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