Regulatory

Visionflex is committed to designing industry-leading medical devices that are effective, elegant, easy to use, and conform to the most stringent customer and regulatory requirements. We proudly maintain a certified ISO 13485 Quality Management System through a systemic approach to risk. Our devices have been approved by the Australian Therapeutic Goods Administration as well as multiple international agencies.

 

Quality Management System
ISO 13485:2016 & EN ISO 13485:2016

   

Certificate MD 646035

Certificate ISO 13485

 

Therapeutic Goods Administration

Australian Flag Telehealth

ProEX and ProEX Mobile ARTG number 305324

GEIS ARTG number 283581

For all Visionflex ARTG entries click here

 

INTERNATIONAL REGULATORY REGISTRATIONS AND APPROVALS

U.S. Food & Drug Administration

United States flag telehealth

ProEX and ProEX Mobile listing number D298044

GEIS listing number D299774

For all Visionflex listings please click here

 

Canada

Canada flag telehealth

Click here for ProEX registration
Click here for GEIS registration

 

European Union

European Union flag telehealth

Click here for ProEX, ProEX Mobile and GEIS registration

 

Vietnam

Vietnam flag telehealth

Click here for the devices approved list

 

Saudi Arabia

Saudi Arabia flag telehealth

Click here for ProEX, ProEX Mobile and GEIS registration