Vietnam Medical Device and IVD Regulations
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Medical devices and IVDs sold in Vietnam are regulated by the Infrastructure and Medical Device Administration (IMDA) under the Ministry of Health (MOH).
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 the revised Decree No. 07/2023/ND-CP, which revised Decree No. 98/2021/ND-CP. 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, which is reviewed by your MAH’s provincial MOH office. 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 are quick by design — an administrative completeness check — with many processed in less than one week.
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.
Regulatory authority and source of truth
This service sits within the current requirements administered by the relevant regulator. Use that glossary entry for the authority's remit, official portal, and contact points; use this page for the task-specific workflow and deliverables.
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One flat annual fee covers registration, representation, and ongoing compliance in Vietnam — no hourly billing, no unexpected invoices.
Frequently asked questions
ISO 13485 evidence is central to Vietnam's quality-system expectations for medical device manufacturers. Confirm that the certificate is valid, issued by an acceptable certification body, and covers the legal manufacturer, manufacturing sites, and activities relevant to the products in the application.
Clinical evaluation is often required for Class C and D devices, which can include literature review, clinical experience with similar devices, or clinical investigation. Clinical investigation is most likely to be needed for higher risk class devices or for devices where there is little or no clinical experience. Information required in this section should be presented as a clinical evaluation report. The clinical evaluation report documents the assessment and analysis of clinical data to verify the clinical safety and performance of the medical device when used as intended by the manufacturer.
Authorization validity and maintenance depend on the certificate type and the current amended framework. Do not rely on expired import-license transition dates. Verify the live record, applicable Decree 98 amendments, and current VIMDA instructions for renewal, amendment, or continued importation before shipment.
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