IMDA — Infrastructure and Medical Device Administration, Ministry of Health
Medical devices in Vietnam are regulated by the Infrastructure and Medical Device Administration (IMDA) under the Ministry of Health (MOH), pursuant to Decree 98/2021/ND-CP, as amended by Decree 07/2023/ND-CP and Decree 04/2025/ND-CP. The framework classifies devices into Type A (lowest risk), Type B, Type C, and Type D (highest risk) — with Type A subject to a simplified declaration process and Types B through D requiring full product registration.
A critical feature of Vietnam's framework is the requirement for a locally registered Vietnamese entity as the registration holder. Foreign manufacturers cannot register devices directly — they must appoint a Vietnamese company (either a wholly foreign-owned enterprise or a local Vietnamese company) to hold the registration on their behalf. This local entity is fully liable for the device's compliance in Vietnam.
The registration dossier must be submitted in Vietnamese to the IMDA's online portal. Technical documentation requirements vary by device type and include manufacturer QMS certification, clinical evidence (or reference to similar approved devices), risk management files, and labelling compliant with Vietnamese requirements. Type D devices require the most extensive documentation and typically take the longest to process.
- Decree 98/2021/ND-CP (as amended by Decree 07/2023 & Decree 04/2025) — primary regulatory framework
- Local Vietnamese entity required as registration holder
- Type A: Declaration (simplified) · Type B–D: Full registration
- Dossier submission in Vietnamese through IMDA online portal
- Post-market vigilance reporting to IMDA mandatory
IMDA Review Timelines by Device Type
Estimated IMDA processing times from submission acceptance — excluding deficiency response periods.
Integrated Services for Vietnam IMDA Registration
IMDA Device Registration
End-to-end management of Type A through Type D device registration with the Infrastructure and Medical Device Administration (IMDA) — including Vietnamese-language dossier preparation, IMDA portal submission, deficiency response, and approval tracking. Classification determination and registration pathway strategy included for all device types.
Local Entity Support
Vietnam requires a locally incorporated entity as the registration holder. JNPMEDI APAC provides local entity coordination and support — connecting you with qualified Vietnamese registration holders and managing the relationship to ensure accountability, compliance, and full transparency throughout the registration lifecycle.
Post-Market & Compliance
Ongoing compliance management under Decree 98/2021/ND-CP — vigilance reporting to IMDA, post-market surveillance and variation submissions for label or device changes, and regulatory intelligence monitoring. Full Vietnamese post-market compliance coverage under one coordinated platform.
Why JNPMEDI APAC for Vietnam IMDA Registration
IMDA requires all registration submissions in Vietnamese. JNPMEDI APAC has direct operational capability in Vietnam — including Vietnamese-language dossier preparation and IMDA portal management — not outsourced to a local agent with no accountability to you.
The local Vietnamese entity requirement can create commercial lock-in if the entity is also your distributor. JNPMEDI APAC helps you structure the local entity relationship to keep regulatory and commercial roles separate — protecting your freedom to change distribution partners without re-registration.
Vietnam registration is frequently pursued alongside Thailand, Malaysia, and Indonesia as part of a Southeast Asia rollout. JNPMEDI APAC coordinates all four markets from its Singapore hub — maximizing technical document reuse, aligning timelines, and managing all four regulatory relationships through a single point of contact.
Vietnam IMDA Registration — FAQ
Yes. Foreign manufacturers cannot register devices directly with IMDA. A Vietnamese-incorporated entity must hold the registration and is fully liable for compliance.
Medical devices in Vietnam are currently governed by Decree 98/2021/ND-CP, as amended by Decree 07/2023/ND-CP and Decree 04/2025/ND-CP. The competent authority is IMDA (Infrastructure and Medical Device Administration) under the Ministry of Health. Circular 30/2015/TT-BYT, which preceded Decree 98, is no longer the operative framework. JNPMEDI APAC monitors all regulatory updates affecting your registered devices.
180–270 days from submission acceptance; excludes deficiency response periods. Vietnamese-language dossier preparation adds 4–8 weeks of project time before submission.
Yes. JNPMEDI APAC coordinates Vietnam alongside Thailand, Malaysia, and Indonesia under a single contract, maximizing document reuse.