Costa Rica Regulatory Framework Medical Device registration

Costa Rican Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Costa Rican market:

Major Regulations

Regulation Year
Establishing regulation of health products in Costa Rica 1973
Regulations on registration, classification, import, and control of medical equipment and biological materials 1973

General Guidance Documents

Document Year
Addresses formal recognition of US FDA approvals as exceeding Costa Rica’s safety standards 2002
Relating to Fees for Registering Medical Devices and other Biomedical Equipment 2005

Specific Guidance Documents

Document Year
Procedures to determine the equivalency of sanitary registration systems of biomedical device and material 2002

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