Regulatory Services

Medical Device Registration in Costa Rica

Complete management of the regulatory file for medical devices before the Costa Rican Ministry of Health under Decree 34482-S — with the advantage of a partner who can also commercially distribute your product.

Request a quote View details

Medical Device Registration Saluvexis Costa Rica

Service detail

What does the sanitary registration service include?

Saluvexis manages the complete cycle of medical device sanitary registration before the Costa Rican Ministry of Health under Executive Decree 34482-S (Regulation for Sanitary Registration, Import and Commercialization of Medical Devices). The service covers from initial product classification to obtaining the certificate and its maintenance during the five years of validity.

Service stages

Device classification: determination of risk class (I, II, III or IV) per Health Canada classification rules applied in Costa Rica.
Documentary review: verification of the manufacturer's technical, regulatory and quality documentation.
Apostille and legalization: coordination of document legalization when required.
Official translation: Spanish translation of technical documentation when applicable.
File submission: filing before the Directorate of Regulation of Products of Sanitary Interest (DRPIS) of the Ministry of Health.
Procedure follow-up: response to objections and requirements until the certificate is issued.
Local regulatory representation: Saluvexis acts as local representative before authorities; the manufacturer retains ownership of the registration.
Registration maintenance: renewals, modifications and updates throughout the lifecycle.

Device categories covered

Hospital medical equipment
Surgical devices and instruments
Implants and prosthetics
In vitro diagnostic devices
Single-use products and consumables
Medical software devices
Ostomy care products

Results

What outcome does the manufacturer obtain?

The manufacturer obtains the official certificate enabling import and commercialization of the medical device in Costa Rica, plus continuous regulatory support during the five years of validity.

Sanitary Registration Certificate

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

Legal representation

Saluvexis as local regulatory representative before authorities; the manufacturer retains ownership of the registration, without needing local presence.

File maintenance

Renewals, post-registration modifications, label changes and technical updates.

Technovigilance

Compliance with the National Technovigilance System: adverse event reporting and traceability.

Import enabling

Product enabled to enter Costa Rica through Saluvexis or another authorized importer.

Distribution option

If the manufacturer wishes, Saluvexis can also commercially distribute the product under an extended contract.

Differentiator

Why Saluvexis instead of a pure regulatory consultant?

International regulatory consultants (Emergo, MDRC, Operon) manage registration and disconnect. Saluvexis offers the same plus the option to continue as an active commercial distributor after registration. The manufacturer decides how far they want to go with a single partner.

Capability	Regulatory Consultants	Saluvexis
Sanitary registration before MoH	✓	✓
Health Canada classification	✓	✓
Sanitary legal representation	Variable	✓ Integrated
Costa Rican local domicile	Not always	✓ MEIC SME
Distribution option afterward	✗	✓
Access to CCSS tenders	✗	✓
Single contract if scaling up	✗	✓

Saluvexis registers your device and, if you decide later, also distributes it. A single local partner with the flexibility to grow with your product.

Coverage

Know your regulatory pathway with intelligence tools

Before investing time and resources in a sanitary registration, Saluvexis helps you understand exactly how your device is classified, which regulatory pathway it will follow, and what documentation you need to prepare.

Classify your device

We determine the risk class (I, II, III or IV) per Health Canada rules applied in Costa Rica under Decree 34482-S, avoiding costly rework.

Prepare your dossier

We identify exactly what documentation your product requires: apostilled CFG, ISO 13485, IFU, labeling, and FDA/EMA approvals that activate simplified pathways.

Navigate your regulatory pathway

We map your complete trajectory: classification → submission → approval → commercialization, anticipating every step and key decision points.

FAQ

Your most common questions

What is Decree 34482-S?

Executive Decree 34482-S is the Regulation for Sanitary Registration, Import and Commercialization of Medical Devices in Costa Rica. It establishes risk-based classification (classes I to IV per Health Canada rules) and documentary requirements for each category.

How long is the sanitary registration valid?

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

Does a simplified pathway apply if my product has FDA approval?

Yes. The Costa Rican regulatory system recognizes US FDA approvals for class III and IV devices, allowing an abbreviated procedure that significantly accelerates approval time.

Does Saluvexis also handle sanitary legal representation?

Yes. Saluvexis acts as the local sanitary legal representative before the Ministry of Health, in addition to managing the registration; the manufacturer retains ownership of the registration. Local representation is mandatory for manufacturers without domicile in Costa Rica.

How are medical devices classified in Costa Rica?

Costa Rica applies a four-class system (I, II, III, IV) based on Health Canada classification rules. Higher classes correspond to higher risk and require more documentation, including clinical studies.

Does Saluvexis distribute after registration or only register?

Both options. Unlike pure regulatory consultants, Saluvexis offers sanitary registration alone or registration + active commercial distribution under a single contract. The manufacturer chooses the model according to their strategy.

Does Saluvexis manage post-registration modifications?

Yes. Label changes, technical modifications, indication expansions and documentary updates are managed as part of the registration maintenance service.

Cross-link