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 Authorities. 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.

IVDR Emergency Kit MDR Emergency Kit Strategic Regulatory Consulting CE Certification Support Italian and European Ministerial Registrations International Registrations outside the EU Local Representative Quality and International GMPs