Global Representation - Medical Devices
Enabling Your Global Expansion – Global Representation & International Registrations
Do you want to market your medical device globally?
Many countries require an in-country representative, or authorized representative, to achieve medical device registration and market access. For many small to medium-sized medical device enterprises, managing these international registrations and fulfilling local medical device regulations in multiple countries is a significant barrier to expansion.
Lumis International is your solution. We act as your trusted in-country representative in 18 key markets – including the EU, UK, US, Latin America, and Asia-Pacific regions. Across five continents, this gives you access to a combined population of over 3 billion people. We simplify your global expansion by managing the regulatory burden, from strategy and documentation to ongoing registrations and vigilance. This allows you to focus on what you do best: growing your business.
Headquartered in Berlin, our team prides itself on providing expert solutions and excellent customer service to ensure you have efficient and rapid market access worldwide. With more than a decade of experience, we’ve built a reputation as a trusted partner for successful global expansion.
Looking to sell your device globally? Simplify your global expansion with our in-country representative service.
Our 3E Advantage: Expertise. Efficiency. Expedited.
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Expert Solutions
Get full lifecycle support, from registrations to vigilance, ensuring compliance and strengthening your competitive edge.
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Delegate Work
Offload the regulatory burden of global registrations and focus on what matters most: growing your business.
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Rapid Access
Leverage our extensive experience in global medical device regulations and representative services for a seamless global expansion
Looking to sell your device globally? Simplify your global expansion with our in-country representative service.
Global In-Country Representative Services
We streamline global market access and provide ongoing support throughout your product’s lifecycle, keeping you compliant and supporting your company’s growth.
1. Strategy
- Selection of suitable markets
- Regulatory project plan for market access
- Consideration of other services (e.g. reimbursement, importing, clinical development)
2. Registrations
- Market registration coordination and support
3. In-Country Representation
- In-country representation established in registered markets
- Review regulatory project plan to consider further global expansion, if appropriate
Our Markets
Our Markets – Expand Your Global Reach:
| Brazil: ANVISA Brazil Registration Holder | China NMPA Local Agent |
| Canada | Hong Kong Local Responsible Person |
| Colombia: INVIMA Legal Representative | Indonesia Local Authorized Representative |
| Mexico: Cofepris Mexico Registration Holder | Japan PMDA Designated Marketing Authoization Holder (DMAH) |
| United States FDA Agent | Malaysia MDA Local Authorized Representative |
| European Union Authorized Representative (EU-REP) | Singapore HSA Local Registrant |
| United Kingdom Responsible Person (UKRP) | Thailand Local Authorized Representative |
| Switzerland Authorized Representative (CH-REP) | Vietnam Marketing Authorization Holder (MAH) |
| Australian TGA Sponsor | India CDSCO Authorized Agent |
Strategy
- Market Selection: Depending on your commercial goals, product type, and existing documentation, we can advise what markets could be prioritised.
- Project Plan: We will construct a plan outlining steps, responsibilities, and timelines to enter the agreed markets.
- Other services: If beneficial for your business strategy or product development, we can support you with importing, reimbursement, and product development via our established partnership network.
Registrations
- Lumis will coordinate the regulatory work needed to register your products in the selected markets and act as your in-country representative.
In-Country Representative
- We will be your liaison with regulatory authorities in the selected markets and fulfil the relevant regulatory obligations.
- If suitable, we can expand your global reach further by considering additional markets – ensuring long-term, sustainable growth.
Latest news & blog articles
Global In-Country Representation: Convert Your Global Ambition to Global Reality
Navigating the complex landscape of medical device regulations across different countries can be a significant challenge for any company. To help our clients overcome these challenges, we are excited to announce the expansion of our in-country representative services to include key markets worldwide.
Global In-Country Representation: Convert Your Global Ambition to Global RealityRead more
Global In-Country Representation: Convert Your Global Ambition to Global Reality
Navigating the complex landscape of medical device regulations across different countries can be a significant challenge for any company. To help our clients overcome these challenges, we are excited to announce the expansion of our in-country representative services to include key markets worldwide.
Global In-Country Representation: Convert Your Global Ambition to Global RealityRead more
Connect with an expert and explore your options!
