The MoleScope device adheres to regulations set out by the following health authorities:

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New Zealand Medicines and Medical Safety Authority

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European Conformity

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Australia's Regulatory Authority for Therapeutic Goods

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Brazilian Health Regulatory Agency

In addition to the health authorities listed above, MoleScope is approved by:

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Health Canada

Santé Canada

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U.S. Food & Drug Administration

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MoleScope devices Design, Manufacture, and Distribution, hold ISO 13485:2016 Quality System Standard certification.