Costa Rica Medical Device Regulations

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

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

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