Medical Devices
Market entry strategy for medical equipment, implants, surgical products, dental lines, aesthetic products and other regulated healthcare technologies.
Medical Devices
MedTech
Pharma
Life Sciences
Brazil Market Entry • LATAM Expansion • Healthcare
Enter Brazil. Expand Latin America. The right way.
LinksComex is a Brazil-based international business development consultancy specialized in market entry and expansion strategies for regulated healthcare companies entering Brazil and selected Latin American markets.
Healthcare market entry
Specialized support for regulated healthcare products.
Entering Brazil or Latin America requires more than finding a distributor. In healthcare, the regulatory route, registration ownership, importer structure, local representative model and commercial partner selection can define the manufacturer’s long-term control over the market.
LinksComex connects regulatory feasibility, commercial strategy and local execution before market commitments are made. Our role is to help companies compare routes, reduce avoidable risks and structure a realistic market entry path.
We support international companies in understanding how Brazil and selected LATAM markets work in practice — from ANVISA strategy and distributor route assessment to partner mapping, go-to-market planning and regional coordination.
MedTech & Healthtech
Support for companies combining technology, healthcare, software, hardware, data, clinical workflows or specialized services.
Pharma & Life Sciences
Strategic route assessment for pharmaceutical and life sciences companies evaluating Brazil or Latin America for licensing, distribution, alliances or expansion.
Before you sign anything
The first partner decision may shape your entire market future.
In regulated healthcare markets, the distributor, importer of record, registration holder and commercial representative are not always the same party.
Assigning registration ownership, broad exclusivity or import responsibilities too early may create dependency, limit market continuity or make future transitions difficult.
Who we are
International business experience built inside the healthcare industry.
LinksComex was founded by Cristina Varela Wolowski, an international business development professional with over 20 years of hands-on experience in healthcare internationalization, market access and B2B partner development.
Her background combines direct industry experience with the practical challenges of regulated healthcare markets — from distributor structures and registration ownership to commercial positioning, partner dependency and regional expansion.
For Medical Devices, MedTech, Pharma and Life Sciences projects, LinksComex brings a regulatory-commercial view to Brazil and selected Latin American markets, helping international companies understand routes, risks, local structures and partner options before committing to market entry decisions.
For Pharma and Life Sciences projects, LinksComex can also activate specialized business development and alliance expertise, including licensing, distribution models, local partner assessment and regional expansion discussions for Brazil and Latin America.
Our approach considers each company’s stage — from early market assessment and country prioritization to partner development, trade fair preparation, commercial validation and a structured continuity route.
Our services
Market entry support from strategy to qualified partner route.
Brazil Market Entry
Structured pathway for foreign healthcare companies entering Brazil, including market assessment, ANVISA implications, business model definition and go-to-market planning.
LATAM Regional Expansion
Regional expansion strategy across selected Latin American markets, with country prioritization, regulatory-commercial benchmarking and local partner coordination.
Regulatory-Commercial Roadmap
Country-by-country assessment connecting regulatory feasibility, registration model, timeline, required documents, risks and commercial route.
Entry Model Assessment
Analysis of distributor-led models, independent regulatory hosting, importer structures, local representation, own entity or phased market entry.
Local Partner Mapping
Identification and qualification of regulatory consultants, registration holders, importers, distributors, representatives and technical/service partners.
Market Development Advisory
Advisory for companies that need to build, grow or manage international markets with clearer positioning, partner strategy and commercial follow-up.
Project flow
From scope diagnosis to qualified partner shortlist.
1
Scope diagnosis
Understand portfolio, approvals, target countries, current leads, business model and urgency.
2
Country prioritization
Define target markets and sequence based on opportunity, feasibility, complexity and risk.
3
Roadmap
Build the regulatory-commercial route per country and identify critical decisions.
4
Partner mapping
Identify local structures and partners aligned with the intended route and control level.
5
Shortlist & action plan
Recommend partner options, next steps, risk points and a realistic implementation path.
Critical questions
What every manufacturer should assess before entering Brazil or LATAM.
Who should hold the registration?
The registration holder may influence future market continuity if the commercial relationship ends.
Is the distributor also the importer?
The distributor, importer of record, registration holder and local representative may require different structures.
Should exclusivity be granted?
Broad exclusivity without performance milestones can block market development for years.
What support is required locally?
Medical devices may require technical, clinical, service, training or post-market support. Pharma and Life Sciences projects may require local regulatory, pharmacovigilance, licensing, BD&L, distribution or alliance support depending on the product, channel and country.
Medical Devices & Pharma
Two regulated industries. One integrated market-entry view.
Medical device route
Assessment of product classification, registration or notification route, registration holder implications, importer/distributor model, technical support needs and post-market responsibilities.
Pharma & Life Sciences route
Support for companies evaluating licensing, distribution, local partner structures, business development and alliance opportunities in Brazil and selected Latin American markets.
Regional comparison
Country-by-country reading of regulatory pathway, business model, local partner requirements, commercial feasibility and priority sequence before committing resources.
Brazil first. LATAM next.
Regional expansion with regulatory-commercial intelligence.
If your company is already investing in Brazil, expanding across Latin America may be closer than it appears. The regulatory frameworks share structural similarities, the commercial dynamics are often comparable and, once the Brazilian route is understood, the incremental effort to assess markets such as Colombia, Argentina, Peru, Mexico, Chile or Ecuador can be approached with a clearer regional logic.
LinksComex has been operating across the region for over two decades — both helping Brazilian companies go international and supporting international companies entering Brazil and Latin America. We speak both languages, in every sense: regulatory and commercial, local and international.
Regulatory & market access references
Healthcare & life sciences trade shows
30-minute introductory call
Let’s assess the Brazil and LATAM route before committing to local partners.
Contact
Ready to enter Brazil or expand across Latin America?
Book a 30-minute introductory call or send us your initial questions. We can discuss Brazil market entry, LATAM expansion, regulatory-commercial roadmap, local partner mapping or international business development for your healthcare company.
lifescience@linkscomex.com
marketentry@linkscomex.com
+55 48 98876-3735
Florianópolis • São Paulo • Brazil
Request a 30-minute call