🇻🇳Vietnam Medical Device Regulations

Decree 04/2025/ND-CP - Amendments to Decree 98/2021 (English)

Latest amendments to Decree 98/2021 on medical device management. Extends IVD registration validity to June 2025 and updates various procedures.

Circular 05/2022/TT-BYT - Classification Details (English)

Detailed implementation circular for Decree 98/2021. Provides classification rules for risk levels A, B, C, D and list of devices requiring import licenses.

Decree 98/2021/ND-CP - Management of Medical Devices (English)

Primary decree governing medical device management in Vietnam. Replaces Decree 36/2016. Establishes ASEAN-harmonized classification, registration procedures, and import requirements.

Nghị định 98/2021/NĐ-CP - Quản lý Trang thiết bị y tế

Official Vietnamese text of Decree 98/2021/ND-CP on medical device management. Includes detailed annexes on classification rules and documentation requirements.

Ministry of Health Vietnam - Medical Equipment Department

Ministry of Health Vietnam regulates medical devices through the Medical Equipment and Construction Department. Oversees device registration, import permits, and market surveillance.

Decree 169/2018/ND-CP - Amendments to Decree 36/2016 (Historical)

Historical amendments to Decree 36/2016 on medical device management. Established procedures for registration and local representative requirements before Decree 98/2021.

Circular 39/2016/TT-BYT - Classification Rules (Superseded)

Historical classification circular (superseded January 2022). Established 4-class risk system A, B, C, D based on ASEAN guidelines. Now replaced by Circular 05/2022.