INTERNATIONAL REGISTRATIONS OUTSIDE THE EU

Towards international markets

Thanks to our network of partner Agencies in more than 20 extra-European Countries, we carry out preparation and support activities for the registration of medical devices and in vitro diagnostic medical devices at the foreign Regulatory Activities.

Some services:

  • Feasibility analysis for placing on the market in the target country.
  • Identification of pre- and post-market regulatory requirements.
  • Pre-screening of the documentation for the adaptation to international regulation.
  • Dossier preparation/registration practices (510(k), MDAL, STED, ASEAN CSDT, dossier, ecc…).
  • Post-practical submission monitoring.
  • Licence holding e Local Representative service.
  • Support in the management of correspondence between the company and the Regulatory Authority of the reference country.
  • Regular renewals.