Medical Device Distributor in Costa Rica

Service detail

What does the Saluvexis distribution service include?

Saluvexis is the medical device distributor for manufacturers commercializing products in Costa Rica and Central America. Unlike regulatory consultants who only handle paperwork, Saluvexis executes the full commercial chain: we register your product before the Ministry of Health, participate in tenders of the Costa Rican Social Security Fund (CCSS), supply private hospitals and clinics, and maintain post-market traceability throughout the entire product lifecycle.

Operation aligned with international standards: FDA, EMA, GMP and ISO 13485. Costa Rican SME certified by MEIC, with licensed regulatory pharmacist and active sanitary operating license from the Costa Rican Ministry of Health.

Service coverage

Public sector: active participation in CCSS tenders and other public institutional tenders through SICOP (Integrated Public Procurement System).
Private sector: continuous supply to private hospitals and clinics in Costa Rica.
Regulatory support: integrated sanitary registration, in-country registration holder representation and regulatory affairs.
Traceability: reporting and compliance with the National Technovigilance System (Decree 39342-S).

Results

What outcome does the manufacturer receive?

The manufacturer obtains complete end-to-end access to the Costa Rican market under a single contract and a single local point of contact.

Sanitary Registration Certificate

Issued by the Ministry of Health, valid for five years, enabling import and commercialization of the medical device in Costa Rica.

Presence in CCSS hospitals

Active participation in public tenders of the Costa Rican Social Security Fund through Saluvexis as a qualified supplier in SICOP.

Supply to private sector

Continuous distribution to private hospitals and clinics in Costa Rica with reliable logistics and documented traceability.

Registration maintenance

Saluvexis handles renewals, modifications and continuous compliance of the sanitary file throughout the product lifecycle.

Traceability and reporting

Compliance with the National Technovigilance System and periodic reports to the manufacturer on commercial and regulatory performance.

A single point of contact

One single local partner responsible for the entire chain: registration, import, distribution, post-market and commercial support.

Differentiator

Why Saluvexis instead of a pure regulatory consultant?

The big names in the regulatory market (Emergo, MDRC, Operon, Veraque) only handle paperwork. They deliver the registration certificate and disconnect. Saluvexis does the opposite: once the product is registered, the real commercial work begins.

Capability	Regulatory Consultants	Saluvexis
Sanitary registration before MoH	✓	✓
In-country registration holder	✓	✓
Active commercial distribution	✗	✓
Participation in CCSS tenders	✗	✓
Supply to private hospitals	✗	✓
Post-sale logistics traceability	✗	✓
One single contract and contact	✗	✓

Saluvexis doesn't just register your product — we also distribute it. One single local partner. One single contract. One single point of contact for the entire Costa Rican market.

FAQ

Your most common questions

Does Saluvexis distribute and register, or only one of those?

Saluvexis does both. It's the main difference vs regulatory consultants in the market. Under a single contract, we handle sanitary registration and execute active commercial distribution to hospitals, clinics and tenders.

How long is the sanitary registration valid in Costa Rica?

The certificate issued by the Ministry of Health under Decree 34482-S is valid for five years and is renewable. Saluvexis manages renewals and modifications throughout the entire product lifecycle.

Does the simplified pathway apply if my product is already FDA-approved?

Yes. The Costa Rican regulatory system recognizes US FDA approvals and allows an abbreviated procedure for Class III and IV devices already cleared or approved by the FDA, significantly accelerating the approval timeline.

Does Saluvexis participate in CCSS tenders?

Yes. Saluvexis is an active supplier in SICOP (Integrated Public Procurement System) and regularly participates in institutional tenders of the Costa Rican Social Security Fund and other public entities.

Which manufacturers does Saluvexis represent?

Saluvexis represents 15 international manufacturers operating in the Americas, Europe, Asia and the Middle East. All our manufacturers are aligned with FDA, EMA, GMP and ISO 13485 standards.

How are medical devices classified in Costa Rica?

Costa Rica applies a four-class system (I, II, III, IV) based on Health Canada's classification rules, per Decree 34482-S of the Ministry of Health. Higher classes correspond to higher risk and require more documentation.

Does Saluvexis handle Spanish labeling?

Yes. Costa Rica requires labels and instructions for use (IFU) to be in Spanish. Saluvexis coordinates translation and validation of labeling artwork as part of the registration and distribution process.