Costa Rica Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for Costa Rica.

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Major Regulations
Document Number Published Language
Log in Decree 41387-S Modifications to the Executive Decree No. 34482-S 41387-S
Log in Law 5395 General Health Law 5395 1973
Log in Regulation for the Registration, Classification, Importation, and Control of Biomedical Equipment and Material 34482-S 1973
General Guidance Documents
Document Number Published Language
Log in Decree 32780-S Establishing the Fees for Registration of Biomedical Equipment and Material 32780-S
Specific Guidance Documents
Document Number Published Language
Log in Decree 36868-S Regulation for the Authorization and Sanitary Control of the Advertising of Products of Sanitary Interest 36868-S
Log in Decree 41423-S Regulation for the Collection Procedures for Changes Subsequent to the Registration of Products of Sanitary Interest 41423-S
Log in CRECEX Alerta Informativa 31 Implementation of Recognition of US FDA Approval (US CFG) 31
Log in Decree 39342-S Regulation for the National System of Technovigilance 39342-S
Log in Comunicado DAC-UPS-002-11 Implementation of Recognition of US FDA Approval (US CFG) DAC-UPS-002-11