The MoleScope device adheres to regulations set out by the following health authorities:
New Zealand Medicines and Medical Safety Authority
European Conformity
Australia's Regulatory Authority for Therapeutic Goods
![ISO image](https://www.dermengine.com/hubfs/Device%20Registration/ISO2_500x500.png)
MoleScope devices Design, Manufacture, and Distribution, hold ISO 13485:2016 Quality System Standard certification.
*MoleScope is FDA Registered *Not available for sale in Canada