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Does my medical device need MOST/MIC ICT conformity certification and declaration in Vietnam?

Describe your device to check whether MOST/MIC ICT conformity certification and declaration may apply, why, what facts are missing, and which official source to review.

1 maintained routes1 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 MOST/MIC ICT conformity certification and declaration check is screening

Checks Wi-Fi, Bluetooth, cellular, NFC, RFID, UWB, telemetry, and proprietary radio approval. 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: Radio and spectrum approval
Regulatory object: product in current mandatory catalogue
Maintained rule status: mandatory if feature
Useful product facts: Radio technologies, bands, power, antenna, module model, approval IDs, and host integration changes.

MOST Circular 36/2026/TT-BKHCN, signed 30 June 2026 and effective 1 July 2026, replaces Circular 29/2025/TT-BKHCN and the former MIC certification/declaration procedure Circular 30/2011/TT-BTTTT and its amendments. Its high/medium-risk catalogues prescribe product-specific conformity procedures and technical regulations. Apply the exact product description, HS scope, frequency/power thresholds and exceptions to each device or module. For example, the short-range-radio exclusion in Annex II note (3) includes Bluetooth and Zigbee below 60 mW EIRP; Wi-Fi/BLE/cellular functionality alone does not establish coverage. Articles 3–4 require appropriately accredited, designated or legally recognized testing organizations for the applicable conformity route. Relevant evidence locators: Articles 3–6, Annex II ICT rows and note (3) (Gazette p. 113).

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

CR marking

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

Source association awaiting review

Radiation

VARANS radiation import/use licence

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

Source association reviewed

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.

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.