Is it a medical device in every market?

Whether the software analyses patient-specific data and provides information used for diagnosis, therapy, monitoring or prediction.

If the product is a device, its class, conformity-assessment route and evidence for CE marking must be established before market entry.

Intended purpose, the output’s significance for a clinical decision and the specificity of medical claims.

Status must be established under Great Britain rules. A qualification reached in another jurisdiction should not be transferred automatically.

Intended use, indications and whether the output is used for diagnosis, treatment or to affect a body function.

If the product meets the device definition, the applicable FDA device type, product code and premarket route must be identified.

Whether the standalone function processes an image, signal or data and provides a recommendation on prevention, diagnosis or treatment.

Qualification affects device class, device or establishment licensing and the Canadian importer. An alternative route may lead to a drug or natural health product.

Therapeutic purpose, clinical use, serious-disease claims and satisfaction of every condition of a specific exclusion.

If the product is a device and no exclusion or exemption applies, it generally requires ARTG inclusion through an Australian sponsor before supply.

Whether the parameter supports fitness only or detects, diagnoses or monitors a disease in an individual.

If the product is a device, its class, conformity-assessment route and evidence for CE marking must be established before market entry.

Claims on the website, app and instructions, and how an alert affects user action.

Status must be established under Great Britain rules. A qualification reached in another jurisdiction should not be transferred automatically.

Disease indications, measurement validation and whether the result drives a diagnostic or treatment decision.

If the product meets the device definition, the applicable FDA device type, product code and premarket route must be identified.

Intended use as reflected in labelling, advertising and sales materials.

Qualification affects device class, device or establishment licensing and the Canadian importer. An alternative route may lead to a drug or natural health product.

Clinical use, warnings about a serious condition and whether the product only measures a non-invasive parameter for general wellness.

If the product is a device and no exclusion or exemption applies, it generally requires ARTG inclusion through an Australian sponsor before supply.

Energy type, target tissue and purpose, medical claims and whether the product removes hair, tattoos or skin lesions.

If the product is a device, its class, conformity-assessment route and evidence for CE marking must be established before market entry.

A stated purpose to treat or alleviate a medical condition and how the effect is communicated.

Status must be established under Great Britain rules. A qualification reached in another jurisdiction should not be transferred automatically.

Intended use, indications, energy and similarity to already classified laser or light-based devices.

If the product meets the device definition, the applicable FDA device type, product code and premarket route must be identified.

Purpose, product representation, how the effect is achieved and advertising claims.

Qualification affects device class, device or establishment licensing and the Canadian importer. An alternative route may lead to a drug or natural health product.

Therapeutic purpose, indications, energy type and setting of use.

If the product is a device and no exclusion or exemption applies, it generally requires ARTG inclusion through an Australian sponsor before supply.

What is disinfected, process level, claimed microorganisms and connection to a specific device.

If the product is a device, its class, conformity-assessment route and evidence for CE marking must be established before market entry.

Intended purpose, use setting and whether the product enables the device to be used as intended.

Status must be established under Great Britain rules. A qualification reached in another jurisdiction should not be transferred automatically.

Surface or device type, disinfection level and exact antimicrobial claims.

If the product meets the device definition, the applicable FDA device type, product code and premarket route must be identified.

Object of use, mode of action, claims and whether the product enables a device to perform as intended.

Qualification affects device class, device or establishment licensing and the Canadian importer. An alternative route may lead to a drug or natural health product.

Label and advertising claims, use on devices and the claimed level of disinfection or sterilisation.

If the product is a device and no exclusion or exemption applies, it generally requires ARTG inclusion through an Australian sponsor before supply.

Principal action, application site, medical purpose and claims to treat, protect, moisturise or control microorganisms.

If the product is a device, its class, conformity-assessment route and evidence for CE marking must be established before market entry.

Whether the principal intended action is physical or pharmacological, immunological or metabolic.

Status must be established under Great Britain rules. A qualification reached in another jurisdiction should not be transferred automatically.

Intended use, effect on body structure or function, chemical action and disease claims.

If the product meets the device definition, the applicable FDA device type, product code and premarket route must be identified.

How the effect is achieved, composition, intended use and market perception of the claims.

Qualification affects device class, device or establishment licensing and the Canadian importer. An alternative route may lead to a drug or natural health product.

Therapeutic purpose, principal action, application site and the complete claim set.

If the product is a device and no exclusion or exemption applies, it generally requires ARTG inclusion through an Australian sponsor before supply.

Wound type, contact duration, barrier or absorption function and the principal/ancillary action of substances.

If the product is a device, its class, conformity-assessment route and evidence for CE marking must be established before market entry.

The principal mode of action of the product as a whole and the claimed effect of an active substance.

Status must be established under Great Britain rules. A qualification reached in another jurisdiction should not be transferred automatically.

Intended use, wound type, composition and whether chemical action provides the primary effect.

If the product meets the device definition, the applicable FDA device type, product code and premarket route must be identified.

Principal action, indications, composition and presentation of the antimicrobial benefit.

Qualification affects device class, device or establishment licensing and the Canadian importer. An alternative route may lead to a drug or natural health product.

Therapeutic purpose, principal mode of action, wound type and function of each substance.

If the product is a device and no exclusion or exemption applies, it generally requires ARTG inclusion through an Australian sponsor before supply.

Whether a human specimen is examined to provide information on physiology, disease, predisposition or treatment response.

If the product is a device, its class, conformity-assessment route and evidence for CE marking must be established before market entry.

Specimen, purpose of the information, lay user and exact indications.

Status must be established under Great Britain rules. A qualification reached in another jurisdiction should not be transferred automatically.

Intended use, specimen type, population, testing setting and use of the result.

If the product meets the device definition, the applicable FDA device type, product code and premarket route must be identified.

Information derived from the specimen, labelling claims and lay self-testing.

Qualification affects device class, device or establishment licensing and the Canadian importer. An alternative route may lead to a drug or natural health product.

Human specimen, medical purpose of the result, user and home/professional setting.

If the product is a device and no exclusion or exemption applies, it generally requires ARTG inclusion through an Australian sponsor before supply.

Disease claims, dose, composition, product presentation and how the principal effect is achieved.

If the product is a device, its class, conformity-assessment route and evidence for CE marking must be established before market entry.

Treatment and prevention language, pharmacological action and the presentation as a whole.

Status must be established under Great Britain rules. A qualification reached in another jurisdiction should not be transferred automatically.

Claim type, ingredient, route of administration and evidence of intended use.

If the product meets the device definition, the applicable FDA device type, product code and premarket route must be identified.

Ingredients, dosage form, therapeutic claims and how the effect is achieved.

Qualification affects device class, device or establishment licensing and the Canadian importer. An alternative route may lead to a drug or natural health product.

Therapeutic purpose, composition, dosage form, claims and product presentation.

If the product is a device and no exclusion or exemption applies, it generally requires ARTG inclusion through an Australian sponsor before supply.