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Authorized Representative

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Authorized Representative

Who Is An Authorized Representative?

An Authorized Representative (AR) is a designated individual or organization in a target market who acts on behalf of a non-resident medical device manufacturer, ensuring compliance with relevant regulations and facilitating market access. Their key responsibilities include device registration, technical documentation submission, and regulatory interactions. They also monitor the safety and performance of the device post-market and report any incidents or adverse events to authorities. They facilitate communication between the manufacturer and regulatory bodies on regulatory matters and ensure device labeling complies with local language and format requirements. Although “Authorized Representative” is the most common term globally, other variations include Responsible Person, Market Authorization Holder, Local Agent, Sponsor, and Local Technical Representative. They help bridge the gap between the manufacturer and local regulatory authorities, ensuring compliance with relevant regulations and facilitating market access.

Different Terminology Used Around The World

Authorized Representative
Responsible Person
Market Authorization Holder
Local Agent
Sponsor
Local Technical Rep

Different terminology used around the world

Authorized Representative
Responsible person
Market Authorization holder
Local Agent
Sponsor
Local Technical Representative

Why OMC?

Difference between using OMC and distributors

OMC Medicals is a strong contender for the role of Authorized Representative (AR) for medical devices, offering distinct advantages over traditional distributorship models. We are a team of seasoned professionals with profound knowledge of medical device regulations across various markets, which facilitates a seamless registration process and ensures ongoing compliance within the target country’s regulatory framework. We specialize exclusively in medical devices, offering specialized support tailored specifically to the unique requirements and challenges inherent in medical device regulations.

OMC Medicals prides itself on fostering lasting partnerships with manufacturers, laying the foundation for sustained regulatory success and market access. By forging a long-term relationship with OMC Medical, you can benefit from our in-depth understanding of your business objectives, regulatory requirements, and market dynamics. This collaborative partnership approach ensures continuity in your market access strategies and provides a solid framework for navigating the evolving regulatory landscape over time.

However, relying solely on distributors for regulatory compliance can present several potential challenges. Conflicts of interest may arise, as distributors may prioritize sales objectives over regulatory considerations, potentially jeopardizing your compliance status and market presence. Limited control over the regulatory process, including communication with regulatory authorities and handling of regulatory submissions and compliance activities, can result in delays, miscommunication, and inefficiencies, ultimately impacting your time-to-market and regulatory compliance objectives. License transfer complications can also arise if you rely on a distributor to hold your marketing authorizations and later switch distributors or assume direct control over your regulatory affairs.

Collaborating with OMC Medicals as your AR allows you direct control over your regulatory processes and communication with regulatory authorities, ensuring you have immediate visibility into the status of your regulatory affairs. This transparency ensures that your regulatory interests are being diligently represented, and any regulatory challenges are effectively managed with transparency and integrity.