For a successful international approval, medical device manufacturers should familiarize themselves early with regulatory requirements and country-specific peculiarities.So, don't let valuable time pass, but talk to our experts in regulatory affairs in a timely manner. We ensure that your product is approved in the target country at the intended time.Contact us now to schedule a no-obligation initial consultation and put our expertise to the test. We look forward to meeting you!
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 international approval services in detail:
- Supporting the creation of registration documents for the approval of medical devices with the authorities in various countries (USA (FDA), Australia (TGA), Canada (HC), China (NMPA), Japan (PMDA)) in accordance with legal requirements,
- Preparing approval applications for international registration procedures,
- Accompanying the approval process, planning and preparing change and renewal requests,
- Communication with regulatory authorities,
- Researching specific regulatory requirements for defined target countries (e.g. UDI, classifications, labeling, re-registrations, etc.).
