Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksDoes my medical device need MME/DONST licence and import permit for radioactive sources and ionizing-radiation equipment in Cambodia?
Describe your device to check whether MME/DONST licence and import permit for radioactive sources and ionizing-radiation equipment 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 MME/DONST licence and import permit for radioactive sources and ionizing-radiation equipment check is screening
Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies to the facility, operator, or installation rather than only the product.
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
- radioactive substances sources and irradiating apparatus
- Maintained rule status
- mandatory for use site
- Useful product facts
- X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.
Cambodia's nuclear and ionizing-radiation safety, security and safeguards function sits with the Ministry of Mines and Energy, exercised through its Department of Nuclear Science and Technology, which acts as the national regulatory authority for ionizing-radiation sources and radioisotopes. In April 2021 the MME adopted a Prakas on the control of importing and use of radioactive materials and radioactive sources, and Cambodia's own national report records that operators hold an operation licence and an import permit issued by MME/DONST, that the licence conditions oblige the holder to appoint a radiation safety officer, to report radiation dose records to the General Department of Energy every two months, and to give 60 days' written notice before decommissioning. The report also states plainly that the comprehensive nuclear law is still in draft, so the regime rests on the MME Prakas and the ministry's establishment instruments (Royal Decree #1213/017 of 6 December 2013 and Sub-decree #137 of 31 October 2018) rather than on a nuclear law. The Prakas text itself was not retrieved, so this row's binding is candidate.
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.
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 Cambodia routes to check
Wireless / radio
TRC type approval of radiocommunication, telecommunication and ICT equipment
Maintained as a mandatory pre-market route.
Source association reviewed
Telecom terminal
TRC qualified-agent certificate for importation, supply and distribution
Handled as an import or shipment-level obligation.
Source association reviewed
Import CoC / PVoC
TRC import permit for restricted radiocommunication and ICT goods
Handled as an import or shipment-level obligation.
Source association reviewed
EMC
EMC test evidence inside the TRC type-approval file
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Electrical safety
Electrical-safety and performance evidence inside the AMDD dossier
Evidence is normally handled inside the medical-device registration route.
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.
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 Cambodia 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 Cambodia?
- 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.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
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