We take your company around the world

In order to access to foreign markets of Medical Devices, it is often necessary to designate a Local Representative: local authorised representative responsible for registration and relations with the Regulatory Authorities of the reference Country and for post-market activities.

Through this service, we ensure you full control of your registrations making you independent of your distributors.

Where required, in complementarity with the Local Representative, we also offer the License Holder service.

Below there are some service applications:

• Europe (European Authorised Representative / Single Authorised Representative for Europe – EU REP).
• Switzerland (Swiss Authorised Representative).
• United Kingdom (UK Responsible Person).
• U.S.A. (US Agent, Official Correspondent, Contact Person, US Initial Importer, US Electronic Medical Device Reporting).
• Canada (Canadian Regulatory Correspondent).
• Australia (Sponsor).
• Brazil (Brazilian Registration Holder – BRH).
• Japan (Marketing Authorization Holder – MAH e Designated Marketing Authorization Holder – DMAH).
• South Korea (Korean Licence Holder – KLH).
• Mexico (Mexican Registration Holder – MRH).
• China (Legal Agent).
• Russia and CIS countries (Local Representative).
• Argentina (Local Authorised Representative – AAR).
• India (Indian Authorized Representative – IAR).

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