Costa Rica medical device regulations
Official sources linkedMinistry of Health rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Resolución MS-DM-4164-2025 | Admissibility Procedure for Medical Device Registration Applications Defines the Ministry of Health admissibility and deficiency-prevention procedure for registration submissions covering medicines and biomedical equipment and materials. Ingested from the PGR SINALEVI full-text service (version 1 of 1): the ministerial resolution of 29 July 2025 with its six RESUELVE clauses, repealing Resolución MS-DM-5946-2024; Spanish is the controlling text. | Registration | July 31, 2025 | Official |
| Decreto 43902-S / RTCR 505:2022 | Biomedical Equipment Classification, Registration, Import, Labeling and Vigilance Core Costa Rican technical regulation covering medical device classification, registration, importation, labeling, advertising, vigilance, and market control, including medical software and mobile applications. Ingested from the PGR SINALEVI full-text service as corpus text: Decreto 43902-S articles 1-7 and transitorios I-IV (current through the Decreto 44431 reform of 11 April 2024), the RTCR 505:2022 body as clauses 1-25 under Disposiciones Generales, and normative annexes A (classification rules) and B (equivalence procedure); Spanish is the controlling text. | General | September 10, 2023 | Official |
| Decreto 43789-S | Medical Device Registration Renewal by Notification Establishes the notification procedure used to renew sanitary registrations for Class 2, 3, and 4 biomedical equipment and materials. Ingested from the PGR SINALEVI full-text service (version 2 of 2, the current expression): articles 1-10 ingested as corpus text, article 10 setting vigencia two months after La Gaceta publication; Spanish is the controlling text. | Registration | February 7, 2023 | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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