• Do you plan to market your device in Canada?

  • Wish to obtain rapid approval for your Canadian product registration?

  • Need to prepare for a quality system inspection from Health Canada?


In the last decade, the Canadian government via Health Canada, has significantly tightened regulatory requirements for registering products and manufacturing quality systems in Canada. The Canadian requirements are an interesting mix of US and European rules and require close study and continuous review to remain up-to-date.
GEMAR offers product registration and quality system assessment services specific for the Canadian regulatory environment and MARKET. We are consistently in contact with pertinent Health Canada personnel regarding Canada’s developing regulatory requirements.