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

New Zealand flag

New Zealand Medicines and Medical Safety Authority

EU flag

European Conformity

Australian flag

Australia's Regulatory Authority for Therapeutic Goods

Brazilian flag

Brazilian Health Regulatory Agency

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

Canada Flag

Health Canada

Santé Canada

USA Flag

FDA

U.S. Food & Drug Administration

ISO image

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