Medical Device Registration & Compliance in Vietnam
Green NRJ provides structured regulatory support for medical devices in Vietnam — covering classification (A–D), registration/announcement pathways, import licensing, labeling and claims review, and post-market compliance to ensure dossier quality and inspection readiness under Decree 98/2021/ND-CP and its latest amendments.
Regulatory Framework (Updated 2026)
Medical devices in Vietnam operate under a structured classification, registration and compliance regime governed by Decree 98/2021/ND-CP and its latest amendments.
Scope of Services
End-to-end regulatory support for foreign manufacturers, distributors, and local importers in Vietnam.
Registration Process
Structured regulatory pathway to reduce rejection risk.
Confirm classification, HS code, intended use, and licensing route before filing.
Compile technical documentation, ISO certificates, CFS, and authorization letter with consistency checks.
Submit via MOH portal, track processing status, and coordinate clarification requests.
Import compliance, renewal planning, labeling updates, and ongoing regulatory monitoring.
Medical Devices – Video Library
Quick explainers and practical guides on medical device classification, dossier preparation, licensing pathways, and common filing pitfalls in Vietnam.
High-level view of Vietnam medical device regulatory pathway and compliance checkpoints.
How classification impacts timelines, dossier structure, and licensing requirements.
What to prepare (LoA, certificates, technical docs) and how authority review typically runs.
Post-approval obligations: labeling, import docs, incident reporting, and audit readiness.
Need Medical Device Registration Support in Vietnam?
From classification and dossier preparation to MOH portal filing and post-market compliance, Green NRJ provides structured, risk-managed regulatory support aligned with Vietnam authority requirements.
Request a Medical Device Regulatory Consultation View all Product Registration services →