International approval of in-vitro-diagnostics: Reaching the goal with the right strategy

As a manufacturer of in vitro diagnostics, you should familiarize yourself with the regulatory requirements and country-specific specifics at an early stage to ensure a successful market entry. Invest in a well thought-out plan and thus avoid unpleasant surprises when it comes to the approval of your products.

Don't waste valuable time, talk to our regulatory affairs experts in good time. We will make sure that your IVD will be approved in the respective target country at the announced time.

Reserve a no-obligation initial consultation now to put our expertise to the test.

Different countries, different customs – that is all the more true in the context of certification and market entry. Use our know-how, stay on the safe side!

Our services in detail:

  • Supporting the creation of registration documents (registration master file) for the approval of medical devices in different countries (Europe (CE), USA (FDA), ...(TGA), MDL, CFDA, PMDA) in accordance with legal requirements,
  • Preparing approval applications for international registration procedures,
  • Accompanying the approval process, planning and preparing change and renewal requests.
  • Researching special regulatory requirements for defined target countries (e.g. UDI, classifications, etc.)