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Does my medical device need CNRP control of installations and sources emitting ionizing radiation in Tunisia?

Describe your device to check whether CNRP control of installations and sources emitting ionizing radiation may apply, why, what facts are missing, and which official source to review.

1 maintained routes1 candidate 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 CNRP control of installations and sources emitting ionizing radiation 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 awaiting review. These are unreviewed candidate links retained from legacy data. They must not be cited as proof that this route or requirement applies.

Requirement family: Ionizing radiation and radioactive sources
Regulatory object: radiation source or installation
Maintained rule status: mandatory for use site
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

Loi n° 81-51 du 18 juin 1981 relative à la protection contre les dangers des sources de rayonnements ionisants (JORT n° 42 du 19 juin 1981), completed by décret n° 86-433 du 28 mars 1986 relatif à la protection contre les rayonnements ionisants, places sources of ionizing radiation under a control regime administered by the Centre National de Radioprotection (CNRP), which studies the application, carries out the control and issues a report and opinion; the applicant files the CNRP's own request form for the study or control. The government service directory publishes the authorisation as taking two months from the date the application is filed. The scheme is bound to the law's official publication card rather than to the instrument text because the CNRP's own texts could not be retrieved and the service directory is served only over http; the requirement's scope for a device that emits ionizing radiation should be confirmed with the CNRP.

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

Other Tunisia routes to check

Check every Tunisia route →

Wireless / radio

CERT homologation of radio and telecommunications terminal equipment

Maintained as a mandatory pre-market route.

Source association reviewed

Product-specific

ANMPS conformity-certificate requirement (CE certificate or ISO 13485)

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

Source association reviewed

Import CoC / PVoC

Import technical control at the ANMPS — Autorisation de Mise à la Consommation

Handled as an import or shipment-level obligation.

Source association reviewed

Candidate sources awaiting review

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.

Ministère des Affaires Sociales

loi n° 81-51 du 18 juin 1981 relative à la protection contre les dangers des sources de rayonnements ionisants (JORT n° 42 du 19 juin 1981)

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 Tunisia 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 Tunisia?: 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.