What is a Medical Device?
The legal definition of a medical device under Vietnamese law — Decree 98/2021/ND-CP.
What is NOT a Medical Device?
Products excluded from the Vietnamese medical device definition under Decree 98/2021.
Regulatory Framework Overview
An overview of Vietnam's medical device regulatory system — MOH, DAV, provincial health departments, and the Decree 98/2021 structure.
Who Must Comply?
Obligations under Decree 98/2021 — Vietnamese manufacturers, foreign manufacturers, importers, distributors, and healthcare facilities.
Lifecycle of a Medical Device in Vietnam
The end-to-end regulatory journey for a medical device in Vietnam — from classification to post-market obligations.