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Does my medical device need VARANS radiation import/use licence in Vietnam?

Describe your device to check whether VARANS radiation import/use licence may apply, why, what facts are missing, and which official source to review.

1 maintained routes2 official source links

Preliminary applicability · country-specific scope

What you receive

Not just a yes or no

A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.

Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.

Official starting points. Open the regulator or government sources behind the maintained country matrix.

Maintained country rule

What this VARANS radiation import/use licence check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies when the product, feature, component, or use is in scope.

Source association reviewed. The source association has been reviewed. This does not verify every rule, date or product-specific conclusion; read the cited provisions and their limits.

Requirement family: Ionizing radiation and radioactive sources
Regulatory object: radiation product or use site
Maintained rule status: mandatory if feature
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

Decree 332/2025/NĐ-CP implements Atomic Energy Law 94/2025/QH15 and replaced Decree 142/2020/NĐ-CP from 1 January 2026 (Điều 107). Điều 22 requires radiation-work licences subject to its specific exemptions; Điều 24 sets conditions for use of medical diagnostic X-ray equipment. The transition in Điều 106(3) preserves existing QCVNs on radiation safety, source grouping and notification/licensing exemptions, together with QCVNs for radiotherapy accelerators and medical X-ray equipment, until replacement. This is not a blanket exemption for those devices. Circular 36/2026/TT-BKHCN separately lists medical diagnostic X-ray equipment (HS 9022.14.00, QCVN 5:2010/BKHCN and 11:2015/BKHCN) and radiotherapy accelerators (including QCVN 13:2017/BKHCN), routing them to atomic-energy-law management rather than the product-quality conformity procedures.

How to read the answer

Classification is only the first layer

A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

Dossier or import evidence

Testing can belong inside the medical dossier, while some documents apply to each shipment.

Site or operator licence

Radiation, installation, use, or measurement controls may apply to a facility or operator.

Country-specific scope

Other Vietnam routes to check

Check every Vietnam route →

Electrical safety

Medical electrical evidence

Evidence is normally handled inside the medical-device registration route.

No supporting source association

Import CoC / PVoC

MOH medical device import licence

Applies when the product, feature, component, or use is in scope.

Source association reviewed

Wireless / radio

MOST/MIC ICT conformity certification and declaration

Applies when the product, feature, component, or use is in scope.

Source association reviewed

Wireless / radio

CR marking

Applies when the product, feature, component, or use is in scope.

Source association awaiting review

Environmental / battery

Environmental EPR

Applies when the product, feature, component, or use is in scope.

Source association awaiting review

Metrology

IMDA verification of in-use devices

Applies to the facility, operator, or installation rather than only the product.

Source association reviewed

Reviewed source associations

Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.

Government of Vietnam / VARANS (MOST)

Decree 332/2025/NĐ-CP radiation-safety licensing under Atomic Energy Law 94/2025/QH15 (replaces Decree 142/2020/NĐ-CP, effective 2026-01-01)

MOST (Bộ Khoa học và Công nghệ)

Circular 36/2026/TT-BKHCN medium/high-risk product catalogue — ICT radio equipment conformity + radiation/nuclear devices routed to atomic-energy law (replaces TT 29/2025/TT-BKHCN and TT 30/2011/TT-BTTTT, effective 2026-07-01)

About this checker

A preliminary tool, not a regulatory determination

Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Vietnam scheme matrix and links each route to its maintained source associations, with reviewed, candidate and unresolved states shown separately.

Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.

Is this the same as medical device classification in Vietnam?: No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
Does “no separate certificate” mean no testing is required?: No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
Is the result an official regulatory determination?: No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.