Planning to introduce a new medicine to the Costa Rican market? The registration process may seem complex, but it doesn't have to be. Saluvexis manages the complete file before the Ministry of Health through the Regístrelo platform, with integrated licensed regulatory pharmacist.
Costa Rica, through the Ministry of Health, regulates the import, distribution, commercialization, prescription and promotion of medicines. This process is conducted through the Sanitary Registration, which has a validity of five years, subject to renewal.
The main regulation governing this process is Executive Decree 43259-COMEX-S-MEIC, published in La Gaceta, which applies the Central American Technical Regulation (RTCA) for Medicine Registration. This regulatory framework establishes the requirements, timelines and procedures to obtain, renew and modify medicine registration in Costa Rica.
Saluvexis manages the complete cycle of pharmaceutical sanitary registration before the Costa Rican Ministry of Health. The service is executed through the Regístrelo platform and complies with the RTCA for Medicine Registration.
Saluvexis manages the complete sanitary registration process before the Ministry of Health under a structured 6-stage flow, each with clear deliverables and professional follow-up.
The Central American Technical Regulation (RTCA) for Medicine Registration establishes the technical requirements for registration, renewal and modification of medicines in the member countries of the Central American Integration System (SICA). Its purpose is regional harmonization of technical regulations to guarantee the quality, safety and efficacy of medicines.
The RTCA applies to medicines manufactured or imported by natural or legal persons for commercialization in the territory of the State Parties.
In addition to the RTCA on Sanitary Registration Requirements, other Central American technical regulations apply to the medicine lifecycle:
Saluvexis covers compliance with all these RTCAs applicable to the product during the registration process and maintenance.
The laboratory obtains the official certificate enabling import and commercialization of the medicine in Costa Rica, plus continuous pharmaceutical support during the five years of validity.
Certificate issued by the Ministry of Health, valid for five years, enabling medicine commercialization.
Saluvexis provides the legally required pharmacist, eliminating the need to hire an external one.
Saluvexis as local regulatory representative before the Ministry of Health; the manufacturer retains ownership of the registration.
Compliance with the National Pharmacovigilance System: continuous reports and monitoring.
Renewals, post-registration modifications and documentary updates.
If the laboratory wishes, Saluvexis can also commercially distribute the product.
Traditional pharmaceutical regulatory consultants only handle paperwork and don't include regulatory pharmacist or distribution. Saluvexis collapses all critical functions for medicines into a single local partner.
| Capability | Regulatory Consultants | Saluvexis |
|---|---|---|
| Pharmaceutical sanitary registration | ✓ | ✓ |
| Compliance with RTCA Medicine Registration | ✓ | ✓ |
| Management via Regístrelo platform | ✓ | ✓ |
| Licensed regulatory pharmacist included | Separately outsourced | ✓ Integrated |
| Operational pharmacovigilance | Variable | ✓ |
| Costa Rican local domicile | Not always | ✓ MEIC SME |
| Distribution option afterward | ✗ | ✓ |
| Single integrated contract | ✗ | ✓ |
Saluvexis registers your medicine with licensed regulatory pharmacist integrated. No need to hire a separate pharmacist, legal representative or pharmacovigilance: everything is included.
Medicine registration in Costa Rica is mainly governed by Executive Decree 43259-COMEX-S-MEIC, which applies the Central American Technical Regulation (RTCA) for Medicine Registration. The Ministry of Health regulates the import, distribution, commercialization, prescription and promotion of medicines through the Sanitary Registration, with five-year renewable validity.
Regístrelo is the official digital platform of the Costa Rican Ministry of Health for managing sanitary registrations of medicines and other regulated products. Saluvexis handles all procedures through this platform as part of the integrated service.
Yes. Any company commercializing medicines in Costa Rica must have a licensed regulatory pharmacist registered with the College of Pharmacists. Saluvexis has an active licensed regulatory pharmacist as part of the service.
Pharmaceutical sanitary registration issued by the Ministry of Health is valid for five years, renewable. Saluvexis handles renewals and post-registration modifications throughout the product lifecycle.
Yes. Saluvexis acts as the local sanitary representative and operates the National Pharmacovigilance System for registered products; the manufacturer retains ownership of the registration. Includes adverse event reporting and traceability.
Saluvexis manages registrations of generic (multi-source), innovator, biosimilar, biologic, specialty, hospital pharmaceutical products and medicines that require bioequivalence studies.
Bioequivalence studies are required for certain medicines according to current regulations. Saluvexis advises the laboratory on specific requirements and, when applicable, on bioequivalence exemptions (bioexemption) based on technical criteria.
Active distribution of class I-IV devices with integrated sanitary registration.
Learn more
Distribution of pharmaceutical products with licensed regulatory pharmacist.
Learn more
Specialized formulas for hospitals: renal, hepatic, immune support.
Learn more
Active participation in SICOP tenders for the Costa Rican Social Security Fund.
Learn more
Direct supply to CIMA, Metropolitano, Clínica Bíblica and Hospital La Católica.
Learn more
Integrated entry to the Costa Rican market under a single local contract.
Learn moreLet's discuss how Saluvexis can support your entry or expansion in Costa Rica.