Fast-Track Your Medical Device Market Entry in Latin America

40% Faster Market Access | 30% Lower Costs | 100% Regulatory Compliance

bioaccess® accelerates medical device and biopharma market access across Latin America with expert regulatory guidance, strategic partnerships, and proven success.

Get Market Access Strategy

$71.00B

Projected Latin American Medical Device Market by 2032

5.00%

Annual Growth Rate

40.00%

Faster Approvals with bioaccess®

100+

Successful Market Entries

Comprehensive Market Access Services

Regulatory Strategy & Compliance

Navigate complex regulatory frameworks across Latin America with expert guidance and proven strategies.

Market Entry Planning

Develop comprehensive market entry strategies tailored to each country's unique requirements and opportunities.

Regulatory Submissions

Expert management of submissions to ANVISA, COFEPRIS, INVIMA, and other regional authorities.

Local Representation

Qualified local representatives ensuring compliance and maintaining regulatory relationships.

Distribution Network Development

Build strategic partnerships with local distributors and establish effective market channels.

Reimbursement Strategy

Navigate healthcare reimbursement systems to maximize market access and adoption.

Post-Market Compliance

Ongoing regulatory maintenance, renewals, and compliance monitoring across all markets.

Why Choose bioaccess® for Latin America?

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20+ Years Combined Experience

Deep expertise in Latin American medical device regulations and market dynamics.

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Proven Track Record

100+ successful market entries across Brazil, Mexico, Colombia, Argentina, and Chile.

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Local Market Knowledge

In-country experts who understand regulatory nuances and cultural considerations.

✓

Cost-Effective Solutions

Reduce market entry costs by 30% through efficient processes and strategic partnerships.

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Accelerated Timelines

Get to market 40% faster with streamlined processes and regulatory expertise.