International Medical Device Registrations

Hair loss is a worldwide problem and Hairmax® is providing worldwide solutions. We diligently work with international governments to provide the safety and clinical evidence to register Hairmax® products as certified solutions to hair loss. Achieving medical device license registrations is a considerable accomplishment, demonstrating to the world the efficacy of Hairmax® and our commitment to providing world class solutions for hair loss.

  • United States – 8 FDA 510(k) OTC Clearances
  • UK – ASA approved efficacy claims
  • European Union – Declaration of Conformity
  • Canada – Health Canada Approval
  • Brazil – ANVISA Registration
  • Mexico – COFEPRIS Approval
  • South Korea – KFDA Approval
  • Egypt – Ministry of Health
  • Australia – TGA Approval
  • United States – 8 FDA 510(k) OTC Clearances
  • UK – ASA approved efficacy claims
  • European Union – Declaration of Conformity
  • Canada – Health Canada Approval
  • Brazil – ANVISA Registration
  • Mexico – COFEPRIS Approval
  • South Korea – KFDA Approval
  • Egypt – Ministry of Health
  • Australia – TGA Approval