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 RPAZ authorisation for radiation sources and irradiating devices in Zimbabwe?
Describe your device to check whether RPAZ authorisation for radiation sources and irradiating devices may apply, why, what facts are missing, and which official source to review.
1 maintained routes3 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 RPAZ authorisation for radiation sources and irradiating devices 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 Authority of Zimbabwe licenses ionising-radiation practices under the Radiation Protection Act [Chapter 15:15] (Act 5 of 2004). Section 14(1) provides that no person shall mine, manufacture, import, export, distribute, sell, possess, use, operate, maintain, transport or dispose of a radiation source or irradiating device except in accordance with prescribed requirements, s.15(1) prohibits administering ionizing radiation without a valid licence, s.15(2) requires the application to be in the prescribed form with the prescribed fee, and s.15(4)(b) gives the licence holder the right to own, purchase, acquire, import, export, possess, sell or deal in, install, use or dispose of irradiating devices and other sources of ionizing radiation. RPAZ's own list of activities requiring authorisation names medical diagnostic and interventional radiology (fixed and mobile x-ray machines, C-arms, fluoroscopy, mammography, bone densitometry, CT scanners, Gamma Knife, Cyber Knife), radiotherapy, nuclear medicine, dental and veterinary radiography, and service providers who supply, install or maintain radiation equipment. The obligation falls on the importing or using facility rather than on a product registration, so a Zimbabwean hospital or clinic must hold the licence before it operates the equipment.
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 Zimbabwe routes to check
Product-specific
MCAZ condom and glove type approval and batch release
Evidence is normally handled inside the medical-device registration route.
Source association reviewed
Wireless / radio
POTRAZ equipment type approval
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Import CoC / PVoC
SAZ consignment based conformity assessment (destination inspection)
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 Zimbabwe 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 Zimbabwe?
- 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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