The Costa Rican Ministry of Health has issued three important provisions for companies and professionals involved in managing health-related products:
- Reactivation of Rejected Applications: The Directorate of Health-Related Products Regulation will assess, on a case-by-case basis, the reactivation of previously rejected files with duly submitted appeals. The decision will take into account the ease of remedying pending requirements, public health impact, and current regulations. This is not an automatic reinstatement, but rather an agile review process to resolve cases without compromising legal compliance.
- Standardized Power of Attorney Guidelines: In response to frequent user requests, the Directorate has issued a standardized guide for preparing the legal power of attorney required in product registrations. The template complies with Article 1256 of the Costa Rican Civil Code and reflects common industry practices.
- Implementation of the Admissibility Process: Starting August 4, 2025, an admissibility stage will precede technical analysis in registration, renewal, and post-registration change procedures, beginning with medicines and biomedical equipment. This measure aims to speed up processing, improve file quality, and optimize technical review. Applicants will have 10 business days to address any observations.
These measures enhance transparency and efficiency, representing a significant step toward modernizing the country’s health product management framework.
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