Global representation for medical devices. Image of a hand holding a globe showing a map of the world

Global In-Country Representation: Convert Your Global Ambition to Global Reality

Topic: Global representative medical devicesOctober 28, 2025,

Your Global Expansion, Our Local Expertise

Navigating the complex landscape of medical device regulations across different countries can be a significant challenge for any company. As global markets continue to evolve, so do the requirements for market entry and in-country representation (sometimes referred as “authorized representative”). To help our clients overcome these hurdles and expand their reach, we are excited to announce the expansion of our in-country representative services to include key markets worldwide.

Global representation for medical devices. Image of a hand holding a globe showing a map of the world

The Challenge of Global Medical Device Market Entry

For a medical device company, securing a CE mark or an FDA 510(k) clearance is a key milestone, but it’s often just the first step. True global success requires a strategic approach to market access, which includes fulfilling the specific in-country representation mandates of different regulatory bodies. Each country—from the U.S. and Canada to Australia and Japan—has its own set of rules, documentation requirements, and submission processes.

A failure to understand and comply with these local requirements can lead to significant setbacks. Regulatory delays can stall your product launch, compliance issues can lead to costly fines, and without a local point of contact, you risk being out of touch with crucial updates from local health authorities. With 90-95% of medical device companies being Small-to-Medium Enterprises (SMEs)1, most manufacturers do not have the capacity or infrastructure to establish themselves across global markets.

Introducing Our Expanded In-Country Representation Services

To address this growing need, we are extending our in-country representation offering. Our new service now covers a comprehensive list of countries, including:

  • North America: Canada, Mexico, United States
  • South America: Brazil, Colombia
  • Europe: European Union, United Kingdom
  • Australia: Australia
  • Asia: China, Hong Kong, Indonesia, India, Japan, Malaysia, Singapore, Thailand, Vietnam

Our expanded service is designed to be a seamless extension of your team, providing the local presence and regulatory knowledge you need to succeed. We handle the intricacies of local regulations, allowing you to focus on innovation and business growth.

Why Partner with Our Regulatory Services Team?

Choosing the right partner for your in-country representation is critical. Our team offers:

  • Deep Local Expertise: We possess extensive knowledge of each country’s specific regulatory environment, ensuring your device remains compliant.
  • Streamlined Market Access: We handle the intricate local processes, from device registration and technical file submissions to supporting post-market surveillance and adverse event reporting. This streamlined approach minimizes delays and helps you bring your products to market faster, giving you a crucial competitive advantage.
  • Cost-Effective Solution: Establishing a physical office or hiring dedicated regulatory staff in multiple countries is often prohibitively expensive. Our service provides a flexible, scalable, and cost-effective alternative that enables your global expansion.
  • Strong Network: We have a range of partners worldwide from Contract Research Organizations to distributors and importing experts who can help achieve your global commercial goals.
  • Risk Mitigation: We help you identify and mitigate potential compliance risks, protecting your brand reputation.

Your Global Regulatory Partner

Whether you are a startup aiming to enter your first international market or an established company seeking to expand your global footprint, our expanded in-country representation services are here to support you. We are committed to being your reliable partner, providing the regulatory content and strategic guidance you need to navigate the global medical device landscape with confidence.

Contact us to learn how our services can help achieve your global market goals.

References

  1. The European Medical Technology Industry in figures 2021. MedTech Europe. www.medtecheurope.org/wp-content/uploads/2021/06/medtech-europe-facts-and-figures-2021.pdf

Liam Spencer

This post was written by Liam Spencer. Liam is Senior Project Manager, Regulatory Consulting and Services.His 8 years’ experience includes both pharmaceutical and medical device regulatory affairs. He has worked across different technologies, including; small chemical entities, ATMPs, biologics, vaccines, combination products, and class I-III devices. Working across all phases of development has allowed Liam to gather a broad understanding of regulatory affairs and, therefore, devise creative regulatory strategies.

This strategic and project management skillset was developed at his previous position as a global regulatory lead for a large CRO (Contract Research Organisation). Throughout his career he has also worked on complex international submissions and helped prepare a variety of regulatory documents such as IMPDs, protocols, investigator brochures, clinical evaluation reports, and device technical files. Liam has worked for companies of different sizes and backgrounds and, with his strong experience in a consultancy environment, he can tailor regulatory solutions to the client’s needs.