In-Country Representation Services
Meet basic compliance requirements prior to medical device and IVD placement in all markets with our consolidated In-Country Representation services.
Streamlined In-Country Representation for Medical Device and IVD Companies
Designating an In-Country Representative, also known as an Authorized Representative in some markets, is required if you are a manufacturer with no legal entity. More than 1,000 medical device and IVD manufacturers trust MedEnvoy as their In-Country Representative.
Meet Your In-Country Representative Regulatory Requirements
Designating an In-Country Representative, also known as an Authorized Representative (AR) in some markets, is required if you’re a manufacturer with no physical location in the market where you are looking to commercialize your medical device or IVD.
Work With a Local Point of Contact
In general, the In-Country Representative’s role is to serve as a local point of contact for authorities should there be a problem with your product. Your representative must be identified on your labeling, support with device registrations, and assist with Incident and Field Safety Corrective Action (FSCA) reporting in cooperation with you and your importer(s) and distributors.
Seamlessly Navigate Regulatory Affairs
With MedEnvoy as your independent In-Country Representative, you can select a partner that focuses on regulatory affairs rather than sales and marketing – as well as a partner that has your best interests in mind. Additionally, it prevents having to select a commercial partner, such as your distributor, from taking on the critical role of an In-Country Representative.
Get Expert Guidance
We share our expertise because we believe in removing barriers to global commercialization.
The Business Impact of EUDAMED on Market Access
The European Database on Medical Devices (EUDAMED) is often viewed by manufacturers purely as a compliance burden when…
MedEnvoy at RAPS Euro Convergence 2026
We are excited to share that MedEnvoy will be participating in RAPS Euro Convergence 2026 as an exhibitor! This year’s…
Key FDA Changes MedTech Manufacturers Need to Know
The FDA has issued an update for MedTech Manufacturers to its List of FDA-Recognized Consensus Standards, published as …