Vietnam Medical Device and IVD Regulations

Vietnam medical device and IVD regulatory framework

Medical devices and IVDs sold in Vietnam are regulated by the Infrastructure and Medical Device Administration (IMDA) under the Ministry of Health (MOH). Current regulations governing the medical device registration were issued in 2021, namely Decree No. 98/2021 (link in Vietnamese), Circular No. 05/2022, and subsequent amendments including Decrees 07/2023 and 04/2025. Vietnam’s medical device regulatory scheme is informed by the ASEAN Coordination Guidelines and the ASEAN Medical Devices Directive.

Regulatory pathways for medical devices and IVDs in Vietnam

IMDA has established two registration pathways to obtain a Marketing Authorization (MA) license based on classification. Medical devices and IVDs are categorized into four tiers based on increasing risk: Class A, B, C, and D.

Low-risk products that are Class A or B follow a notification process that requires a Declaration of Applied Standards application, through the currently competent authority and administrative service. Class C and D devices must undergo a full technical review of a Marketing Authorization Registration application under the MOH.

While reference market approval is not required, it can qualify a Class C or D application for Vietnam's fast-track registration form. Acceptable reference markets under Decree 98 include GHTF member countries (USA, Canada, Europe, Japan, or Australia) as well as the United Kingdom, China, South Korea, and Switzerland. Class A and B declarations follow an administrative route, but dossier completeness, local-holder readiness and current portal procedures still determine practical timing. Do not treat a historical sub-week estimate as a guaranteed authorization date.

Additional medical device and IVD regulatory requirements in Vietnam

All devices imported by foreign manufacturers must appoint a local representative, known as a Marketing Authorization Holder or MAH. Your MAH is responsible for submitting the MA application to IMDA online system, acting as your liaison with IMDA during the application review, issuing Letters of Authorization for distributors and importers.

Build the route and evidence record

Check the latest Ministry portal instructions and amendments before relying on an old import transition or fast-track checklist. Decree 98 remains the core framework, while Circular 24/2026 adds a current classification and technical-inspection reference. A historical extension of an import document is not a permanent substitute for the applicable declaration or registration.

Record the A–D class and grouping, the local holder's eligibility, authorization letter, manufacturer/QMS evidence, free-sale or qualifying reference approvals where applicable, CSDT/evidence index and Vietnamese labels. Assess fast-track eligibility against the exact approval type, device and current conditions rather than a country list alone.

Before supply, define dossier access, importer/distributor authorizations, complaint escalation, distribution traceability and postmarket changes. Confirm government fees and review targets at filing and separate them from translations, testing and applicant response time.

For regulatory terminology and the authority framework, see the Vietnam Ministry device authority.