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 Radiation Protection Inspectorate licence to possess, sell, use or import ionizing radiation sources in Botswana?
Describe your device to check whether Radiation Protection Inspectorate licence to possess, sell, use or import ionizing radiation sources 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 Radiation Protection Inspectorate licence to possess, sell, use or import ionizing radiation sources 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
- radiation product importer or use site
- Maintained rule status
- mandatory for use site
- Useful product facts
- X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.
The Radiation Protection Inspectorate states that 'pursuant to the Radiation Protection Act, 2006 and Radiation Protection Regulations 2008, any person who wishes to engage in activities which involve ionizing radiation sources must obtain a licence to do so', and lists the licensable activities as acquiring, owning, possessing, transferring, distributing, selling, using, manufacturing, transporting, importing or exporting any radioactive material, substance or source, administering a radioactive substance for diagnosis, treatment or research, and managing or disposing of radioactive waste. Applications are made on Form 2 (Application for License/Permit to Import/Export/Transport/Possess and Use of Radioactive Sources/Generators/Equipment) and Form 01 (Ionizing Safety User Registration), and the Inspectorate publishes its own service clocks: assessment feedback within 10 days, gazette publication not less than 7 days before the Board meeting, and the applicant informed of the Board's decision within 3 days of the meeting. The licence runs to the facility that imports, possesses or uses the equipment rather than to the device's BoMRA registration.
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 Botswana routes to check
Electrical safety
BoMRA electrical safety and EMC evidence in the device dossier
Evidence is normally handled inside the medical-device registration route.
Source association reviewed
Wireless / radio
BOCRA communications equipment type approval
Maintained as a mandatory pre-market route.
Source association reviewed
Import CoC / PVoC
BOBS compulsory standards (Standards (Compulsory Standards) Regulations — Botswana Product Conformity Programme)
Handled as an import or shipment-level obligation.
Source association awaiting review
Metrology
BOBS Trade Metrology Unit — verification of weighing and measuring instruments for trade
Applies when the product, feature, component, or use is in scope.
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 Botswana 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 Botswana?
- 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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