Vietnam Consolidates Medical Device Management Regulations

On March 16, 2020, Vietnam’s Ministry of Health issued Integrated Document No. 01/VBHN-BYT, consolidating the [...]

Decree 07/2023 Updates Medical Device Regulations

On March 3, 2023, the Government of Vietnam issued Decree No. 07/2023/ND-CP, amending and supplementing [...]

Vietnam Issues Internal Procurement Manual for Healthcare Supplies

On June 3, 2026, Vietnam’s Ministry of Health issued Decision No. 1589/QD-BYT, promulgating a manual [...]

Guidance on Medical Device Price Quotations

On September 22, 2026, the Department of Public Procurement under the Ministry of Finance issued [...]

Vietnam Adopts Non-IVD CSDT Assessment Criteria

On January 22, 2024, Vietnam’s Ministry of Health issued Decision No. 166/QD-BYT, promulgating the criteria [...]

Vietnam Sets IVD CSDT Assessment Criteria

The Ministry of Health of Vietnam has issued Decision No. 49/QD-BYT, promulgating the criteria and [...]

Vietnam Issues Guidance on the Review of Legal Documents for Medical Device Marketing Authorization Applications

On August 5, 2024, Vietnam’s Ministry of Health issued Decision No. 2302/QD-BYT, promulgating guidance on [...]

Vietnam’s Detailed Regulations on the Implementation of Decree No. 98/2021/ND-CP on Medical Device Management

The Ministry of Health of Vietnam issued Circular No. 05/2022/TT-BYT dated August 1, 2022, providing [...]

Vietnam Issues Circular No. 44/2025/TT-BYT on Decentralization of Medical Device Regulatory Procedures

The Ministry of Health of Vietnam has issued Circular No. 44/2025/TT-BYT dated November 22, 2025, [...]

Decree No. 98/2021/ND-CP on the Management of Medical Devices

On November 8, 2021, the Government of Vietnam issued Decree No. 98/2021/ND-CP on the Management [...]

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