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Does my medical device need Regulation 62 physical-force performance claims in New Zealand?

Describe your device to check whether Regulation 62 physical-force performance claims may apply, why, what facts are missing, and which official source to review.

5 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 Regulation 62 physical-force performance claims check is screening

Checks laser, UV, ultrasound, RF, microwave, magnetic, acoustic, and other emitting-product controls. Evidence may be required, but the matrix does not identify a generic separate certificate.

Requirement family: Non-ionizing radiation
Regulatory object: device with physical force claims
Maintained rule status: evidence only no separate certificate
Useful product facts: Energy type, wavelength or frequency, class, power, intended effect, and existing product reports.

Medicines Regulations 1984 reg 62: a medical device claimed to operate by inducing, concentrating, directing or producing magnetic, galvanic, electrical, electromagnetic, radiation or vibratory forces must not be sold unless the claimed properties are quantitatively described to the purchaser in writing in terms measurable by scientific physical means and the device demonstrably has those properties.

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.

Radiation

Radiation Protection Act 1965 licensing

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

Wireless / radio

Radiocommunications Act 1989 compliance

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.

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.

Medsafe

regulation 62 performance-claim requirements for physical-force devices

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.