Authorized Representation

Overview

Many jurisdictions require foreign medical device manufacturers to appoint a local authorized representative before their products can be placed on the market. This representative acts as the legal point of contact between the manufacturer and the regulatory authority, ensuring that regulatory obligations are met and that communication channels remain open.

At Veritas Quality Solutions, we provide access to a global panel of qualified authorized representatives across key markets. Whether you need an EU Authorized Representative, a Swiss Authorized Representative, a UK Responsible Person, a US Agent, or representation in other regions, we connect you with experienced professionals who understand the regulatory landscape and can fulfill your obligations efficiently.

Why Authorized Representation Matters

Legal Requirement

In many jurisdictions, appointing an authorized representative is a legal precondition for market access. Without one, your device cannot be legally placed on the market.

Regulatory Obligations

Authorized representatives carry specific responsibilities defined by regulation. These include maintaining documentation, liaising with regulatory authorities, and ensuring that the manufacturer complies with post-market obligations.

Local Expertise

An authorized representative based in the target market understands local regulatory requirements, language, and administrative procedures. This local knowledge helps manufacturers avoid delays and navigate complex requirements efficiently.

Post-Market Support

Authorized representatives play a critical role in post-market surveillance, vigilance reporting, and incident management. They serve as the local contact point for regulatory authorities and customers.

Our Authorized Representation Services

1. European Authorized Representative (EC REP)

Under EU MDR 2017/745, manufacturers established outside the European Union must appoint an Authorized Representative established within the EU. The EC REP acts on behalf of the manufacturer in fulfilling specified regulatory obligations.

Responsibilities of the EC REP:

Verify that the EU Declaration of Conformity and technical documentation are available

Maintain a copy of the technical documentation and Declaration of Conformity

Register the manufacturer and device in EUDAMED

Cooperate with Notified Bodies and Competent Authorities

Manage vigilance reporting and Field Safety Corrective Actions

Terminate the mandate if the manufacturer acts contrary to its obligations

Provide the manufacturer with information on complaints and incidents

Our EC REP Services:

Appointment of an experienced EC REP within the EU

Coordination of regulatory obligations between manufacturer and EC REP

Support for EUDAMED registration and updates

Assistance with vigilance and incident reporting

Ongoing communication with Competent Authorities

Management of mandate agreements and renewals

2. Swiss Authorized Representative (CH REP)

Under the Swiss Medical Devices Ordinance (MedDO), manufacturers established outside Switzerland must appoint a Swiss Authorized Representative (CH REP) for devices placed on the Swiss market.

Responsibilities of the CH REP:

Act as the contact point for Swissmedic

Maintain the technical documentation and Declaration of Conformity

Register devices with Swissmedic

Manage vigilance reporting and Field Safety Corrective Actions

Cooperate with Swiss authorities on compliance matters

Our CH REP Services:

Appointment of a qualified CH REP based in Switzerland

Registration of devices with Swissmedic

Support for post-market surveillance and vigilance

Coordination with Swiss regulatory authorities

Management of mandate agreements and renewals

3. UK Responsible Person (UK REP)

Following the UK's withdrawal from the European Union, manufacturers established outside the UK must appoint a UK Responsible Person (UK REP) for devices placed on the Great Britain market (England, Scotland, and Wales).

Responsibilities of the UK REP:

Register devices with the MHRA

Maintain the technical documentation and Declaration of Conformity

Act as the contact point for the MHRA

Manage vigilance reporting and Field Safety Corrective Actions

Cooperate with UK authorities on compliance matters

Our UK REP Services:

Appointment of a qualified UK REP

Registration of devices with the MHRA

Support for post-market surveillance and vigilance

Coordination with the MHRA

Management of mandate agreements and renewals

4. US Agent

Under FDA regulations, foreign manufacturers of medical devices must appoint a US Agent. The US Agent serves as the primary contact point for FDA communications and is responsible for specific regulatory obligations.

Responsibilities of the US Agent:

Act as the contact point for FDA communications

Assist with establishment registration and device listing

Facilitate FDA inspections and correspondence

Receive and respond to FDA inquiries on behalf of the manufacturer

Maintain familiarity with the manufacturer's devices and operations

Our US Agent Services:

Appointment of an experienced US Agent

Support for FDA establishment registration and device listing

Coordination of FDA communications and responses

Assistance with inspection preparation and management

Management of agent agreements and renewals

5. Saudi Authorized Representative

Under SFDA requirements, foreign manufacturers must appoint a Saudi Authorized Representative (AR) who is licensed by the SFDA to act on their behalf.

Responsibilities of the Saudi AR:

Submit and manage Medical Device Marketing Authorization (MDMA) applications

Communicate with SFDA on behalf of the manufacturer

Maintain technical documentation and regulatory records

Manage post-market surveillance and vigilance reporting

Facilitate SFDA inspections and audits

Ensure compliance with Saudi regulatory requirements

Our Saudi AR Services:

Appointment of a licensed Saudi AR

MDMA application preparation and submission

Coordination with SFDA on regulatory matters

Support for post-market surveillance and vigilance

Assistance with SFDA inspections

Management of AR agreements and renewals

6. Other Market Representatives

Beyond the major markets, many other jurisdictions require local representation. We provide access to representatives in additional markets as required by local regulations.

Markets We Support:

Turkey (TITCK registered representative)

Brazil (ANVISA registered representative)

Australia (TGA Sponsor)

New Zealand (Medsafe Sponsor)

Indonesia (Local Authorized Representative)

Malaysia (MDA registered representative)

Thailand (Thai FDA registered representative)

Russia and EAEU (authorized representative)

Azerbaijan (local representative)

Other markets as required

How We Support You

Panel Access

We maintain an established panel of authorized representatives across key markets. This allows us to connect you with qualified professionals who understand your device, your regulatory strategy, and your business objectives.

Agreement Management

We assist with the development and review of representation agreements, ensuring that responsibilities, obligations, and termination provisions are clearly defined and aligned with regulatory requirements.

Coordination

We coordinate between you, your authorized representative, and other regulatory service providers, ensuring that information flows smoothly and that obligations are met on time.

Ongoing Support

Authorized representation is not a one-time appointment. We support ongoing compliance, including post-market surveillance, vigilance reporting, and communication with regulatory authorities.

Why Choose Veritas Quality Solutions

Global Network

We have established relationships with authorized representatives across Europe, the UK, the USA, the Middle East, Asia-Pacific, and other regions, giving you access to local expertise wherever you market your devices.

Regulatory Expertise

Our team understands the specific responsibilities and obligations of authorized representatives in each jurisdiction. We ensure that your representation arrangements satisfy regulatory requirements and support your compliance objectives.

End-to-End Support

From appointment through ongoing compliance, we support the entire authorized representation lifecycle. We manage the administrative burden so you can focus on your core business.

Practical Approach

We tailor our services to your specific needs. Whether you require representation in a single market or multiple jurisdictions, we develop a solution that fits your regulatory strategy and budget.

Proven Track Record

We have supported manufacturers across device classes and therapeutic areas in establishing authorized representation arrangements and maintaining compliance in markets worldwide.

Get Started

Whether you are entering a new market for the first time or seeking to streamline your existing representation arrangements, Veritas Quality Solutions is ready to help.

Veritas Quality Solutions, Your Partner in Quality Assurance