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 OAP radiation-generator licence in Thailand?
Describe your device to check whether OAP radiation-generator 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 OAP radiation-generator 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
- product and 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.
The OAP-authored regulatory-framework presentation hosted by IAEA (pages 19–21) distinguishes licensing from notification under the Nuclear Energy for Peace Act: Category 1 (at least 1 MeV) and Category 2 (below 1 MeV, not fully enclosed during operation) generators require OAP licensing; fully enclosed Category 3 generators below 1 MeV follow OAP notification and regular safety inspection. Generators specifically designed for medical diagnostics follow the Ministry of Public Health notification route; generators with maximum energy at or below 5 keV are listed as exempt. For the licensed categories, the presentation gives five-year production/possession/use licences and import/export/transit licences of no more than six months. Confirm the current category and implementing instrument for the specific device; this framework presentation does not establish a blanket licence requirement for all non-diagnostic generators.
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 Thailand routes to check
Electrical safety
Thai FDA electrical/EMC evidence
Evidence is normally handled inside the medical-device registration route.
Source association reviewed
Wireless / radio
NBTC SDoC
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Wireless / radio
NBTC Class A
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Wireless / radio
NBTC Class B
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Adapters / components
TISI compulsory standards mark
Applies when the product, feature, component, or use is in scope.
No supporting source association
Halal / materials
Halal certification
Normally voluntary or driven by a buyer, tender, workplace, or local authority.
No supporting source association
Import CoC / PVoC
Thai FDA import establishment licensing
Handled as an import or shipment-level obligation.
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 Thailand 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 Thailand?
- 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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