Tiếng Việt
On 30 June 2026, the Ministry of Health issued Circular No. 24/2026/TT-BYT, introducing regulations on risk classification and management measures for medical devices in Vietnam.
Key Highlights:
🔹 Risk Classification of Medical Devices
The classification of medical devices and corresponding regulatory controls will continue to be implemented in accordance with Decree No. 98/2021/ND-CP and its guiding regulations.
🔹 Clarification on Dossier Codes
Dossier Codes for medical devices shall be applied in accordance with Circular No. 19/2024/TT-BYT, which provides the list of medical devices with designated import and export tariff classifications.
🔹 Revised Timeline for Medical Device Inspection and Verification
The Circular amends Article 8 of Circular No. 05/2022/TT-BYT regarding safety and performance verification requirements:
Medical devices procured after 30 June 2027 must undergo verification in accordance with procedures issued by the Ministry of Health.
Medical devices procured before 1 July 2027 must complete verification before 1 January 2028.
🔹 Effective Date
The Circular takes effect on 1 July 2026. At the same time, Circular No. 59/2025/TT-BYT will cease to be effective.
📖 Read the full Circular: https://www.slideshare.net/slideshow/thong-t-2026-v-qu-n-ly-r-i-ro-va-ki-m-d-nh-thi-t-b-y-t-t-i-vi-t-nam/288438622
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