Medical Device Regulations from Costa Rica's Ministry of Health in PDF

Costa Rica Medical Device Regulations

All documents were published by the Costa Rican Ministry of Health and are in PDF format. The Costa Rica Ministry of Health updates their database of approved devices on a monthly basis: Costa Rica Ministry of Health database of approved devices (in Spanish).

Major Regulations


Document	Language	Number	Published
Establishing regulation of health products in Costa Rica	es	5395	1973
Regulations on registration, classification, import, and control of medical equipment and biological materials	es	34482-S	1973

General Guidance Documents


Document	Language	Number	Published
Addresses formal recognition of US FDA approvals as exceeding Costa Rica's safety standards	es	DM-F-1518-2011	2002
Relating to Fees for Registering Medical Devices and other Biomedical Equipment	es	32780	10/2005

Specific Guidance Documents


Document	Language	Number	Published
Procedures to determine the equivalency of sanitary registration systems of biomedical device and material	es	DAJ-RM-1151-08	2002