The Drug Administration of Vietnam (DAV — Cục Quản lý Dược) is Vietnam's national regulator for human medicines, biologicals, vaccines and cosmetics. DAV operates under the Ministry of Health (Bộ Y tế) from Hanoi under the Law on Pharmacy No. 105/2016/QH13 (2016), Decree 54/2017/ND-CP and Circular 32/2018/TT-BYT as amended. Medical devices are regulated separately by the Department of Medical Equipment and Health Works (Vụ Trang thiết bị và Công trình y tế) under Decree 98/2021/ND-CP (as amended by Decree 07/2023/ND-CP), with a four-class (A/B/C/D) risk-classified pathway aligned to IMDRF and AMDD principles.

Vietnam participates in ASEAN medicines and medical-device harmonisation. Medicines are registered under the ASEAN Common Technical Dossier (ACTD) format for generics with ICH CTD accepted for innovator products; DAV operates reliance pathways for reference-authority approvals (FDA, EMA, MHRA, Health Canada, TGA, Swissmedic, PMDA) that shorten review timelines. Vietnam works towards PIC/S membership and reached WHO Maturity Level 3 for vaccines regulation in 2015.

GMP inspections of overseas manufacturers are risk-based; PIC/S / EU / FDA GMP certificates support desk review, while biologicals, sterile products, vaccines and high-risk devices attract on-site inspection. Vietnam enforces a pharmaceutical serialisation and traceability programme for controlled drugs. V5 Ultimate maps directly onto DAV expectations — bound e-signatures, ALCOA+ batch records, deviation/CAPA workflow, and a per-country dossier pack — with the paired guide at /glossary/vietnam-dav.

Industries that live with this

Pharmaceutical Medical Devices

How V5 handles it

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

QMS — quality engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.