MDSS – Authorized Representative Services & Regulatory Consulting

MDSS: Your trusted partner for In-Country Representation & comprehensive regulatory support!

For over 30 years, MDSS (mdssar.com) has been a trusted Authorized Representative specializing in Regulatory Affairs for Medical and In Vitro Diagnostics devices.

We offer comprehensive In-Country Representation across the EU, UK, Switzerland, USA, and Australia, designed to minimize complexity, save time, and reduce costs, allowing you to focus on your core business, including innovation.

MDSS is a member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA), Swiss Medtech and the Medical Technology Association of Australia (MTAA).

In-Country Representation Services

  • European Authorized Representative (EC REP)
  • EU Representative – GPSR
  • EU Representative – GDPR
  • Legal Representative for the Sponsor
  • National Registration
  • Free Sales Certificate
  • Importer of products
  • U.S. Agent to the FDA
  • UK Responsible Person (UKRP)
  • Swiss Authorized Representative (CH-REP)
  • Australian TGA Sponsor

Other Services

  • Regulatory Consulting
  • Cosmetics (Safety and legal compliance for cosmetic products)