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Mongolia medical device certification and licence checker

Check Mongolia requirements beyond medical-device classification, including radio, electrical, metrology, radiation, import, environmental, and product-specific routes.

5 maintained routes6 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.

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

Medical device certification routes in Mongolia

Wireless / radio

CRC type approval and conformity mark for information and communication equipment

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

Source association reviewed

Metrology

Legal metrology: type approval, state-database registration and verification of measuring instruments

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

Source association reviewed

Radiation

Licence for radiation generators: possession, use, sale, transport, import and export

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

Source association reviewed

Import CoC / PVoC

Per-consignment import declaration for registered medical devices

Handled as an import or shipment-level obligation.

Source association reviewed

Electrical safety

Electrical safety and EMC evidence inside the device registration dossier

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

Source association reviewed

Official starting points

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.

Communications Regulatory Commission of Mongolia (ХХЗХ)

register of directions, terms and requirements of procedures approved by the CRC — ICT type-approval guideline (Resolution No. 29 of 2019) and conformity-mark guidance (Resolution No. 43 of 2019, CHTJ010-2019)

Communications Regulatory Commission of Mongolia (ХХЗХ)

Баталгаажуулалт (certification) page — mandatory certification for equipment on the Annex 1 list to Government Resolution No. 291 of 2018, application documents including six-year health/safety, EMC and RF test results, the 5-working-day decision notice, the conformity mark and the scheme-dependent fee annex to Board Resolution No. 13 of 2020 (Mongolian)

Medicines and Medical Devices Control and Regulatory Agency (ЭЭХХЗГ)

Annex Two to Order A/206 of the Minister of Health of 26 May 2025 — medical device registration procedure: dossier items including the verification report and ISO 13485 certificate, list-entry stages and the import-adjacent controls

Medicines and Medical Devices Control and Regulatory Agency (ЭЭХХЗГ)

Law on Metrology — type approval, state-database registration and verification of measuring instruments, including instruments used in the diagnosis and treatment of humans

Medicines and Medical Devices Control and Regulatory Agency (ЭЭХХЗГ)

Law on Medicines and Medical Devices — device registration and listing, exempt categories and the per-consignment import declaration (Arts. 33, 44)

State central administrative body in charge of education (nuclear energy)

Nuclear Energy Law — licences to possess, exploit, sell, transport, import and export radiation generators (Art. 15.3)

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 Mongolia 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 Mongolia?: 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.