Medical devices are officially regulated as "biomedical equipment and material" in Costa Rica. The Costa Rican Ministry of Health oversees the country’s medical device market, and subjects all devices, except certain low-risk products, to registration before commercialization can occur. Home country medical device approval is required for registration in Costa Rica.
Through our worldwide network of consultants, industry contacts, and regulatory sources, Emergo can provide in-depth analysis of all major medical device markets, including Costa Rica. Our Regulatory Pathway service provides the following information: