A map of the world in colour with various countries marked with pins. A pin marking Brazil is in the centre.

How Small Medical Device Companies Can Successfully Go Global

Topic: Global representative medical devicesNovember 15, 2025,

Key Points:

  • Global expansion enables long-term, robust growth
  • Expanding into new markets is complex and risky
  • A multi-disciplinary team is required for reliable, strategic planning
  • With the correct planning, global expansion is an achievable goal for even small medical device companies with limited resources.
A map of the world in colour with various countries marked with pins. A pin marking Brazil is in the centre.

Global expansion for a medical device SME isn’t about simply selling a product in a new country; it’s a strategic undertaking that requires a series of critical decisions. The choices you make before you even enter a new market will determine your success and sustainability. Here are key decisions a medical device SME should make before going global.

1. Commercial Viability  

Firstly, you should decide on which market(s) offer commercial opportunities. However, you should limit your market choice to align with your available resources. Entering a new market takes considerable resources and given most device companies are small-to-medium enterprises, it is often appropriate to prioritize your global expansion to one or two markets at a time. This minimizes risks whilst maximizing your chance of successful market access.

  • Market Research: Conduct a comprehensive analysis of potential markets. Look at the prevalence of the condition your device treats, the size of the patient population, and the demographics of the country. Consider the competitive landscape: Are there similar devices already on the market? How successful are the competitors in this market?
  • Economic Viability and Reimbursement: Assess the economic conditions of the target country. Is there a strong healthcare budget? Does your product fit into the current care pathway and the market’s healthcare system? Are there reimbursement policies that favor your device? Understanding the local reimbursement system is crucial for ensuring that hospitals and clinics can actually afford to use your product.
  • Political and Cultural Stability: Look for a stable political environment and a culture that is open to adopting new medical technologies. Unstable political climates can lead to sudden, disruptive regulatory changes and supply chain issues.
  • Intellectual Property (IP) Protection: Patent protection is limited to geographical regions, what is protected in one market may not be protected in another. Therefore, check your IP is suitably protected before entering a market.

2. Developing a Regulatory Strategy

The regulatory environment for medical devices is complex and varies from country to country. Your regulatory strategy is your roadmap to compliance.

  • Classification: Correctly classify your device in the target market. Many countries’ classification system is based on the International Medical Device Regulators Forum (IMDRF)1. However, the process of classification can differ significantly – e.g. between Japan and the EU. And even for similar processes, like with the EU and Australia, the product class can still differ. Therefore, make sure you classify your product in each target market according to their regulations.
  • Submission Pathway: Identify the correct regulatory submission pathway for your device. This could be a 510(k) clearance in the U.S., a CE Mark in the EU, or a specific submission to a local authority like Japan’s PMDA or Brazil’s ANVISA. In some countries, foreign regulatory approvals (e.g. CE-mark) are recognized and can streamline the submission process – e.g. Australia. Whereas, in other countries their regulatory process is distinct and more involved. Knowing the submission workload during strategic planning can help confirm the feasibility of entering the target market.
  • Evidence and Documentation: Determine what clinical and non-clinical evidence is required. Some countries may accept data from U.S. or EU trials and laboratories, while others may demand local data to prove safety and efficacy in their population. A well-organized technical file and quality management system are non-negotiable for all regions.
  • In–Country Representation: Many markets require a local representative for product registration and market access (e.g. USA, EU, China, India, etc.), this entity is sometimes known as an authorized representative. The in-country representative acts as a liaison between you and the regulatory authority, however, the representative’s responsibilities can vary by jurisdiction. For example, the EU authorized representative (EU-REP) has more responsibility than representatives in some other markets. Sometimes distributors can act as in-country representatives which can provide a convenient two-in-one solution; however, it may limit your flexibility in the future in changing your distribution network.

3. Selecting a Go-to-Market Model

How will you actually get your device into the hands of healthcare professionals and patients? Your go-to-market model needs to be carefully chosen.

  • Direct Sales: This involves building your own sales team and distribution network in the target country. It offers the most control but is expensive and time-consuming. It’s often most feasible for high-margin, high-volume products.
  • Distributors: Partnering with local distributors is a very common strategy for SMEs. Distributors have existing relationships, local market knowledge, and established logistics. However, you must conduct thorough due diligence to ensure they are reputable and have expertise in your device and therapeutic area. As mentioned above, it is often advantageous to have an independent in-country representative, separate from the distributor, to provide you with greater control over your distribution and commercial operations.
  • Hybrid Models: You can start with a distributor and then transition to a direct sales model once you have a strong foothold. This is a great way to scale your presence over time.

4. Crafting a Localized Strategy

Your product, marketing, and messaging must be tailored to the local market. What works in one country may not resonate in another.

  • Localization vs. Translation: Localization is more than just translating your user manuals and marketing materials. It involves adapting your product to local standards, including power plugs, units of measurement, and even user interface design.
  • Supply Chain: Many medical devices require specific storage conditions (e.g., temperature control). Maintaining these conditions throughout a complex international supply chain adds layers of difficulty and expense. Consider finding a suitable logistics partner for this role.
  • Marketing and Sales: Develop a marketing plan that speaks to the specific needs and values of the target audience. The sales approach should also be adapted to local business culture and customs.
  • Post-Market Surveillance: Plan for robust post-market activities, including adverse event reporting and user feedback systems, in compliance with local regulations. This is crucial for maintaining market access and demonstrating a commitment to patient safety.

Summary

Global expansion is a long-term goal for many SME medical device companies but it can be considered unachievable due to the risks, challenges, and complexity. To mitigate these difficulties, careful planning involving a multi-disciplinary team is essential. Commercial, regulatory, distribution, sales, and supply chain are just some factors which must be considered to ensure the expansion will yield a return on investment. Furthermore, a key aspect of any global expansion, especially for SMEs, is partnering with compatible companies who can facilitate your expansion. Resource management ensures the expansion plan’s scope is aligned with available capacity and, where necessary, activities are outsourced (e.g. distributors, logistics, translations).

Global expansion offers long-term opportunities for medical device companies, particularly SMEs. It expands revenue streams, de-risks overreliance on individual markets, and improves brand awareness and reputation. All these benefits are conducive to robust long-term growth and with a multi-disciplinary strategic plan, they are an achievable goal.

How Can Lumis Help?

Lumis International is a consultancy specializing in representative services and medical device regulatory affairs. We have been representing medical device companies for over 10 years and have a team of expert medical device regulatory professionals. In addition to regulatory planning and consultancy, we provide global in-country representative services in 18 markets, across 5 continents. We also have partners in distribution, reimbursement, importing, and development to facilitate global expansion. Hence, Lumis can act as a strategic partner to unlock your global growth. 

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.

Throughout his career, Liam has also worked on complex medical device international submissions across various countries and continents, providing a foundation to understanding global expansion from a regulatory perspective.

His strategic and project management skillset was developed at his previous position as a global regulatory lead for a large CRO (Contract Research Organisation). 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.