Local Partner for International Manufacturers in Costa Rica

Service detail

What does Saluvexis offer to international manufacturers?

Saluvexis is the end-to-end local partner for medical device, pharmaceutical and clinical nutrition manufacturers wishing to commercialize in Costa Rica and Central America. We combine the three critical functions required by a foreign manufacturer: In-Country Legal Regulatory Representative, sanitary registration and active commercial distribution.

We represent 15 international manufacturers of manufacturers operating in the Americas, Europe, Asia and the Middle East, all aligned with FDA, EMA, GMP and ISO standards.

What an international manufacturer needs in Costa Rica

In-Country Legal Regulatory Representative: Costa Rican entity acting as titleholder of the sanitary registration before the Ministry of Health.
Sanitary Registration: mandatory procedure for every sanitary product before import or commercialization.
Regulatory Pharmacist: required to distribute medicines (Costa Rican College of Pharmacists).
Commercial Distribution: logistics and commercial network to reach CCSS hospitals, private hospitals and pharmacies.
SICOP Qualification: to participate in public tenders.
Continuous Regulatory Compliance: Technovigilance, Pharmacovigilance, renewals and modifications.

Saluvexis covers all 6 functions under one contract

Unlike models where the manufacturer hires regulatory consultant, legal representative and distributor separately, with Saluvexis everything is managed with a single local partner.

Results

What outcome does the international manufacturer obtain with Saluvexis?

The manufacturer obtains complete and operational entry to the Costa Rican market under a single local contract, without the need to open its own office or hire multiple providers.

CR market entry

Access to the Costa Rican healthcare market without the need for own physical presence in the country.

Sanitary registration

Product registered with the Ministry of Health and enabled for import and commercialization.

Legal representation

Saluvexis as local sanitary representative before authorities; the manufacturer retains ownership of the registration.

Public and private access

Active distribution in CCSS hospitals, private hospitals, clinics and pharmacies.

Periodic reporting

Commercial, regulatory and Technovigilance/Pharmacovigilance information to the manufacturer.

A single partner

All Costa Rica operations managed by Saluvexis under one contract.

Differentiator

Commercial modalities for international manufacturers

Saluvexis offers three main commercial relationship modalities, which can be combined according to the international manufacturer's strategy.

Available modalities

Integrated model (recommended): Saluvexis acts as In-Country Legal Regulatory Representative, regulatory manager and commercial distributor under a single contract. Most efficient model for manufacturers without local presence.
Regulatory-only model: Saluvexis manages sanitary registration and legal representation while the manufacturer uses another commercial distributor. Useful if the manufacturer already has a distributor relationship but needs a legal representative.
Distribution-only model: Saluvexis distributes products already registered by another entity. For manufacturers that already have a registration titleholder but seek to expand commercial channels.

Typical terms

Multi-year contracts with automatic renewal
Exclusivity or non-exclusivity territorial
Sales commission or wholesale model
Initial investment in sanitary registration (official fees + professional fees)
Registration maintenance and continuous regulatory support

Saluvexis prepares a personalized comprehensive proposal after a no-commitment initial evaluation meeting.

Schedule Initial Meeting

Coverage

What we do for international manufacturers

Saluvexis is not just a regulatory checkpoint: we execute the complete market entry chain in Costa Rica through three integrated capabilities that cover everything from initial commercial intelligence to final delivery.

Market Access Coordination

Market research & demand forecasting
Competitive mapping & pricing context
Tender opportunity screening
Strategic launch planning

Sales & Commercialization

Go-to-market execution planning
Institutional and private channel positioning
Stakeholder coordination
Commercial performance tracking

Secure Distribution & Storage

Distribution planning
Inventory coordination
Cold chain oversight (if required)
Traceable delivery execution

These three capabilities operate integrated under the same contract with regulatory services (sanitary registration, legal representation, regulatory pharmacist). A single local partner, end-to-end execution.

Operations

Why Saluvexis instead of hiring multiple providers?

The traditional model to enter Costa Rica as a foreign manufacturer involves hiring: a regulatory consultant (Emergo, MDRC, Freyr), a sanitary legal representative, an independent regulatory pharmacist and one or more commercial distributors. Four or more parallel contracts. Saluvexis collapses everything into one.

Function	Traditional model (multiple providers)	Saluvexis (integrated)
Sanitary registration	Regulatory consultant	Saluvexis
In-Country Legal Regulatory Representative	Legal firm or trustee	Saluvexis
Regulatory pharmacist	Separately hired professional	Saluvexis (internal licensed)
Commercial distribution	Independent distributor	Saluvexis
CCSS tenders	Third party with SICOP	Saluvexis (active supplier)
Pharmacovigilance/Technovigilance	Variable	Saluvexis
Number of contracts	4 or more	1
Points of contact	Multiple	One only

Saluvexis is what an international manufacturer truly needs in Costa Rica: an end-to-end local partner. We don't just register your product — we represent it, distribute it and defend it commercially.

FAQ

Your most common questions

Why do I need a local partner in Costa Rica?

Costa Rican regulations require every imported sanitary product to have a registration titleholder (sanitary legal representative) domiciled in Costa Rica. Additionally, medicines require a licensed regulatory pharmacist. Saluvexis fulfills both functions.

Does Saluvexis offer a no-commitment initial meeting?

Yes. We offer a no-commitment initial evaluation meeting to understand your product, assess specific regulatory requirements and propose the most appropriate commercial model for your market entry strategy.

How long does it take to enter the Costa Rican market with Saluvexis?

It depends on the product type and available documentation. Products with FDA, EMA or other ICH authority approval usually have more agile processes under recognition decrees. Saluvexis defines a specific timeline for each case.

Does Saluvexis work with manufacturers of medical devices, medicines and nutrition?

Yes. All three categories are our specialty. We represent 15 international manufacturers of manufacturers in these three areas with operations in the Americas, Europe, Asia and the Middle East.

Can I work with Saluvexis and maintain another distributor in Central America?

Yes. Saluvexis is flexible: we offer exclusive or non-exclusive distribution, and legal representation with or without commercial function. Each model is agreed in the contract.

Does Saluvexis help evaluate the potential of my product in Costa Rica before investing?

Yes. As part of the no-commitment initial meeting, Saluvexis shares general information about the Costa Rican market relevant to your product, without exposing confidential information about our internal management.

Can Saluvexis represent my product only regulatorily without distributing it?

Yes. We offer a regulatory-only model (registration holder + registration + pharmacovigilance/technovigilance) for manufacturers who already have a different commercial distributor.