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Does my medical device need Radiation Safety Act 2016 source and use licences in New Zealand?

Describe your device to check whether Radiation Safety Act 2016 source and use licences may apply, why, what facts are missing, and which official source to review.

5 maintained routes5 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 Safety Act 2016 source and use licences 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.

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

The Radiation Protection Act 1965 is spent. Radiation Safety Act 2016 s 5 defines irradiating apparatus as electrical equipment that emits ionising radiation and a radiation source as radioactive material or an irradiating apparatus. Section 13 forbids, unless the Act or regulations provide otherwise, manufacturing, possessing, managing or controlling a radiation source without a source licence, using a radiation source without a use licence, and importing or exporting radioactive material without a consent. Section 17 is the source licence; s 15 lists the limited cases where a source licence is not required (including transport). Import of an X-ray generator is therefore a possession/control question under s 13(a), not the s 13(c) radioactive-material consent.

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 New Zealand routes to check

Check every New Zealand route →

Adapters / components

Electricity Act 1992 compliance

Applies when the product, feature, component, or use is in scope.

Wireless / radio

Radiocommunications Act 1989 supplier declaration against the Radio Standards Notice

Applies when the product, feature, component, or use is in scope.

Adapters / components

PECPR pressure-vessel certification

Applies when the product, feature, component, or use is in scope.

Laser / UV / ultrasound

Regulation 62 physical-force performance claims

Evidence may be required, but the matrix does not identify a generic separate certificate.

Official starting points

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.

New Zealand Legislation

Radiation Safety Act 2016 ss 5, 13, 15 and 17 — source licence, use licence and irradiating apparatus

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 New Zealand scheme matrix and links each route to its official source.

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 New Zealand?: 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.