Vietnam is a growing medical device market with a pragmatic regulatory approach: devices already approved by the US FDA, EU, Japan, Australia, or Canada qualify for a streamlined "reference country" pathway that can significantly reduce registration timelines. Our database indexes 12,000+ DAV records.
Search Vietnam registrations →The Drug Administration of Vietnam (DAV) operates under the Ministry of Health (MOH) and is the competent authority for medical device registration in Vietnam. The regulatory framework is established under the Law on Medical Examination and Treatment and associated circulars, with Circular 05/2022/TT-BYT being among the most recent to shape current requirements.
Vietnam's healthcare sector has been growing rapidly, driven by rising incomes, a growing middle class with higher healthcare expectations, and significant government investment in hospital infrastructure. The market is estimated at USD 2–3 billion annually for medical devices and growing at 10–15% per year. Vietnam currently imports the majority of its advanced medical devices.
Vietnam uses a four-class system aligned with ASEAN principles, labeled A through D:
| Class | Risk Level | Examples | Notes |
|---|---|---|---|
| Class A | Lowest | Cotton gauze, tongue depressors, examination gloves | Declaration of conformity; no registration required |
| Class B | Low-Moderate | Syringes, blood pressure monitors, diagnostic reagents | Registration required; reference pathway available |
| Class C | Moderate-High | Hemodialysis machines, ventilators, implantable orthopedics | Registration required; reference pathway available |
| Class D | Highest | Implantable cardiac devices, drug-eluting stents | Full review; reference pathway reduces documentation burden |
* Class A devices require a declaration of conformity but not formal DAV registration. Our database primarily covers registered Class B–D devices.
Vietnam's most distinctive feature for foreign manufacturers is the reference country pathway. Devices with valid approvals from any of Vietnam's recognized reference countries — the United States (FDA), European Union (CE marking), Japan (PMDA), Australia (TGA), or Canada (Health Canada) — can submit to DAV using a streamlined documentation package that relies heavily on the foreign approval rather than requiring a full independent technical review.
In practice, this pathway can reduce Vietnam registration timelines significantly compared to what would be required without a recognized foreign approval. For companies that already hold FDA 510(k) clearance or CE marking, Vietnam registration is often one of the lower-barrier entries in the region. The reference country approach is not automatic — you still need to submit the correct documentation and have a licensed local agent — but it removes the most time-consuming elements of the review process.
Like other markets in the region, Vietnam requires a local regulatory agent — a Vietnamese-registered company that holds the registration and takes responsibility for the device's market presence in Vietnam. The agent must have a valid business registration certificate covering medical device activities.
Registration validity is five years. Renewal should be initiated before expiry to avoid gaps in legal status.
Formal submissions to DAV must include Vietnamese-language labeling and documentation. Technical documents may be submitted in English with Vietnamese translations for key sections, but the label affixed to the device and the instructions for use available in Vietnam must be in Vietnamese. This is a practical cost to budget for, particularly for companies with diverse product lines.
Our Vietnam dataset covers registered Class B, C, and D devices with normalized manufacturer names, device classifications, and registration status. Vietnam registrations are particularly useful for cross-market comparison — companies present in Vietnam but not in larger markets like Indonesia or Malaysia may represent strategic distribution gaps or emerging market entries worth tracking.
12,000+ records, searchable alongside 7 other Asian markets. 50 free searches per month.
12,000+ records. See who's registered in Vietnam's growing medical device market. 50 free searches to start.