Health Canada regulates the sale of drugs and medical devices in Canada. Medical devices and in vitro diagnostic devices are classified through different systems but the systems are dividing them into class I, II, III and IV. Quality management systems must be applied for all medical devices except class I products. To sell or advertise a class II, III or IV product in Canada manufacturers need a device licensing but not an establishment license although distributors and importers do. Our country specific (*) regulatory services in Canada include;

Medical Device specific regulation strategy reports in Canada, Medical Device Registration with Health Canada, Health Canada Technical documents Preparation, CMDCAS audit compliance and Arazy Group unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

Please fill the following form, submit your inquiry or discuss it with one of our online specialist available to take your call. Let's get your products registered in Canada!

(*) Canadian Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.