All documents listed below are available from the South African Department of Health. Electromedical devices fall under the scope of the Hazardous Substances Act, No...
Costa Rica Medical Device Regulatory Strategy Report
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.
Let Emergo assist you in evaluating the Costa Rican medical device regulatory framework as it applies to your device(s).
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:
- Regulatory Background on the Costa Rican Ministry of Health
- Device Classification
- In-Country Representation Considerations
- Medical Device Registration Requirements
- Labeling and Language Requirements
- Costs and Timeframes
- Regulatory Roadmap for Costa Rica
- Post-Market Vigilance Requirements