You don’t need to know the LATAM market.
You don’t need local partners.
You don’t need to understand the regulatory pathways.

That’s our job.

To begin working together, you only need the fundamentals, and most manufacturers already have them.

1) A Product Ready for Market

Your device should be:

• In late development or already approved in your home market
  
  
• Ideally with FDA or CE Mark (or close to obtaining it)
  
  

Why this matters:
Most LATAM regulatory agencies request documentation very similar to what you’ve already produced for FDA/CE (TD, IFU, clinical data, QMS certs).

 So you’re not starting from zero, you’re adapting and translating.

2) A Sense of Your Pricing Positioning

Not final pricing,  just direction:

• Are you premium, mid-range, or value?
  
  
• What’s the value story behind your product?
  
  

Why this matters:
Your price positioning determines which distributors we target and how we tell your product story.

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3) Strong Marketing & Clinical Materials

• Professional website that provides clear, localized information about your device.
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• Brochures and product guides highlighting the unique selling points of your device.
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• Clinical evidence or case studies demonstrating real-world effectiveness.
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• Training materials or videos to help distributors and clinicians understand how to use your device effectively.

Why this matters
Investing in well-crafted marketing materials enhances your credibility and speeds up the sales process

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4) Comprehensive Technical Documentation

Standard product documentation you likely already have:

• Instructions for Use (IFU), regulatory-compliant documentation explaining how your product is used
  
  
• Technical specification sheets outlining product features, performance, and safety information
• Packaging and labeling information, country-specific regulations and include necessary warnings or instructions
  
  

Why this matters
This is the basis for distributor evaluation and regulatory filings.

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5) A Quality & Regulatory Foundation

A quality system that shows your device was developed under medical device standards, typically:

• ISO 13485 certification (Quality Management System for medical devices)
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• Good Manufacturing Practices (GMP) compliance
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• Clinical evaluation reports
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• Risk management documentation (ISO 14971)
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• Post-market surveillance plans
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• Biocompatibility and safety testing reports

Why this matters
A well-structured quality system ensures a smooth regulatory approval process and increases confidence among distributors and healthcare providers.

You don’t need to know each country’s regulatory pathway, we guide that part.

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Leave the Rest to medikana

Expanding into LATAM can seem overwhelming—but that’s where medikana comes in. Once you have the foundational elements in place, we take care of the heavy lifting, including:

• Regulatory pathway analysis: Identifying the fastest and most cost-effective way to register your device in LATAM countries.
• Distributor matchmaking: Connecting you with qualified distributors already working in your target markets.
• Go-to-market strategy: Ensuring you have the right commercial approach to maximize success in LATAM.
• Operational support: Handling everything from logistics and local partnerships to compliance and marketing assistance.

You focus on your business as usual.
We focus on getting it into the market.

Ready to Explore LATAM with Confidence?

Let’s have a conversation about your product and priority markets.

Schedule an intro call

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