In-Country Representation

Overview

Ensure compliance with essential regulations before placing your medical devices and IVDs on international markets through our comprehensive In Country Representation Services.
Many regulatory frameworks require manufacturers to appoint a local representative before products can be registered, imported, or commercialised. MDRA provides trusted Authorised Representative Services to help manufacturers meet regulatory obligations, maintain compliance, and access global markets with confidence.
As part of our Regulatory Representation Services, we act as a reliable point of contact between your organisation and regulatory authorities, supporting both market entry and ongoing compliance activities throughout the product lifecycle.

European Authorised Representative (EU REP)

Any manufacturer without an EU establishment wishing to place medical devices or in vitro diagnostics on the European market must appoint an EU Authorised Representative. MDRA supports manufacturers by fulfilling the legal responsibilities associated with EU representation, helping ensure compliance with applicable regulations while supporting efficient market access across Europe.

Swiss Authorised Representative (CH-REP)

Any manufacturer without a Swiss establishment wishing to market medical devices or in vitro diagnostics in Switzerland may be required to appoint a Swiss Authorised Representative. Our team provides practical guidance and regulatory support to help manufacturers meet Swiss requirements and maintain continued access to this important market.

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UK Authorised Representative (UKRP)

At MDRA, we are fully qualified to act as your UK Responsible Person for medical devices. As your UK Responsible Person, we support registration requirements, regulatory communications, and ongoing compliance obligations, helping manufacturers meet UK regulatory requirements efficiently and effectively.

Global Regulatory Representation for Medical Device Manufacturers

Managing regulatory requirements across multiple regions can be complex. Through our Global Regulatory Representation services, MDRA helps manufacturers coordinate representation obligations across key international markets while maintaining a consistent regulatory strategy. Whether you require a Medical Device Authorised Representative in Europe, a UK Responsible Person, a Swiss Authorised Representative, a US FDA Agent, or support in emerging markets, our team delivers practical guidance aligned with your commercial and regulatory objectives. We regularly support manufacturers seeking market access and Medical Device Registration Support in: ,Canada ,Australia ,UK ,UAE ,European Union ,Switzerland ,United States ,Egypt and Saudi Arabia.

Medical Device Registration Support

Effective regulatory representation is often closely linked to successful registration and market access activities. Alongside our In Country Representation Services, we provide Medical Device Registration Support to help manufacturers prepare for regulatory submissions, manage compliance obligations, and maintain market access following approval. By combining regulatory expertise with a practical understanding of global requirements, we help simplify complex pathways and support successful expansion into new markets.

Need Help with Regulatory Strategy?

Whether you are entering a new market, appointing an authorised representative, or developing a global compliance strategy, MDRA can help. Contact our team today to discuss your regulatory requirements and explore the most effective route to market for your medical devices and IVDs

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US FDA Agent for Medical Devices&IVDS

Appoint MDRA as your US FDA Agent and benefit from experienced regulatory support throughout the registration process. As your US FDA Agent, we act as your liaison with the Food and Drug Administration, facilitating communication and supporting regulatory requirements for medical devices and IVDs entering the United States market.

Person Responsible for Regulatory Compliance (PRRC)

A PRRC, or Person Responsible for Regulatory Compliance, is a vital role within organisations operating under modern medical device regulations. MDRA can support manufacturers in understanding PRRC responsibilities and implementing appropriate compliance processes to help maintain regulatory oversight throughout the product lifecycle.

Egypt Registration Holder (ERH)

Egypt presents a promising opportunity for medical device and IVD companies, characterised by steady growth and strong demand for imported technologies. Our team supports manufacturers in understanding local registration requirements and navigating the regulatory pathway required to access the Egyptian market successfully.

Saudi Arabia Authorised Representative

To market a medical device in the Kingdom of Saudi Arabia (KSA), manufacturers must comply with registration requirements established by the Saudi Food and Drug Authority (SFDA). MDRA provides support with local representation requirements, regulatory submissions, and compliance activities to help facilitate successful market entry.