Simplifying Compliance Across Industries
Our Firm’s extensive experience and in-depth knowledge of regulatory requirements in Costa Rica enables us to provide our Clients with a comprehensive service. This includes legal counsel from the preliminary stages of obtaining a Sanitary Registration (or Recognition of Registration), such as company registration before the relevant authorities, registration of legal powers, updating of permits, label compliance review, and other legal requirements.
We also offer guidance and representation during the post-registration phase, particularly in connection with potential market inspections or health authority verifications.
This ensures that products are properly registered and legally marketed, significantly reducing the risk of non-compliance with regulatory requirements.
Our services further extend to handling regional procedures across the rest of Central America.
Regulatory Requirements in Costa Rica:
The Costa Rican Ministry of Health (Ministerio de Salud – MINSA) is the competent authority for issuing Sanitary Registrations and regulating the commercialization of products intended for human consumption.
Sanitary Registrations encompass food products, cosmetics, pharmaceuticals, medical devices, hygiene products, and agricultural goods, as well as raw materials (subject to notification procedures).
Products intended for animal consumption are primarily regulated by the Ministry of Agriculture and Livestock (Ministerio de Agricultura y Ganadería – MAG).
Depending on the type of product, registration (or notification) may be carried out through either a standard procedure or a simplified procedure.
Once the product and any potential restrictions are identified, we provide strategic advice on the appropriate registration pathway and regulatory compliance process.
The regulatory framework also allows for the figure of “registration use,” which permits third parties to utilize an already-registered sanitary permit issued by MINSA.
Related Procedures Include:
- Changes to the applicant’s legal name
- Changes to the manufacturing site
- Modifications to the ingredient list
- Transfers of registrations
- Brand or product name changes or extensions
- New product presentations
- Mutual recognition procedures
Regulatory Requirements in Central America:
While there are Central American Technical Regulations (RTCA) that govern many of the registration and compliance requirements across the region, each country has specific regulatory nuances that must be addressed on a case-by-case basis depending on the product in question.
Our Firm provides legal counsel and representation in each country through local regulatory experts. This ensures an effective and secure process, tailored to each jurisdiction’s unique regulatory environment.
Each case is approached individually to determine the appropriate registration pathway and to offer competitive pricing aligned with our Clients’ needs.
As in Costa Rica, all processes are documented in our proprietary platform (FIDATO), allowing Clients to easily consult and track the status of their cases.
