In-Country Representation
Overview
Ensure compliance with essential regulations before placing your medical devices and IVDs in any market by utilizing our comprehensive In-Country Representation services.
If you are a manufacturer without a legal entity in the target market, appointing an In-Country Representative often referred to as an Authorized Representative in certain regions is mandatory.
- Europe & UK
European Authorised Representative (EU REP)
Any manufacturer without an EU establishment that wants to place medical devices or in vitro diagnostics
Swiss Authorised Representative (CH-REP)
Any manufacturer without an EU establishment that wants to place medical devices or in vitro diagnostics
UK Authorised Representative (UKRP)
At MDRA, we are fully qualified to act as your UK Responsible Person for medical devices.
Person Responsible for Regulatory Compliance (PRRC)
A PRRC, or Person Responsible for Regulatory Compliance, is a vital role within organizations.
- americas
US FDA Agent for Medical Devices&IVDS
Appoint MDRA as your U.S. FDA Agent and learn what we do as your liaison with the FDA.
- middle east
Egypt Registration Holder (ERH)
Egypt presents a promising opportunity for medical device and IVD companies, characterized by steady growth and a strong demand for imported devices.
Saudi Arabia Authorised Representative
To market a medical device in the Kingdom of Saudi Arabia (KSA), it is mandatory to register the device with the Saudi Food and Drug Authority (SFDA)