Get market approval for your IVD Device

The USA , China and Brazil are attractive markets with unique regulatory demands for IVD manufacturers. Depending on the product classification, a specific and generally complex approval process can pose challenges to obtaining market access.

We help you to meet regulatory demands in these markets and to find the easiest way of getting market approval. Our team, supported by native speakers, can help you with all regulatory affairs questions on selecting the correct category for your IVD device, placing the product on the market in a timely manner and maintaining a compliant product.

Need guidance or help for approval of your IVD product?

Take advantage of our services:

  • Product classification (including the borderline sector)
  • Regulatory strategy for market approval (based on 21 CFR, ANVISA, CMDR or NMPA)
  • Technical documentation
  • Search and recommendations for a U.S. agent
  • Registration of your company and products in the FDA database
  • Premarket notification 510(k) and premarket approval (PMA)
  • Clinical evaluation according to NMPA
  • Prepare or review of submission dossiers

Please contact us if you want more information or a non-binding offer on our Regulatory Affairs services.