REGULATORY AUTHORITY: The Ministry of Health is the competent authority for medical and in-vitro diagnostic devices in Costa Rica.
CLASSIFICATION SYSTEM: Medical devices are divided into four classes (I, IIa, IIb and III) depending on the risk level.
TIMEFRAME: Medical devices are registered in Costa Rica within a period of 6-8 months. Review timelines depend on the class of the device.
SPECIAL REQUIREMENTS: Foreign Manufacture on-site audit, local test, or local clinical study is not required.
LOCAL FEES (New Application):
Class I – 10$ USD
Class II – 25$ USD
Class III & IV – 50$ USD
LOCAL FEES (Manufacture): N/A
LICENSE VALIDITY: Licenses issued in Costa Rica expire after five years.
LICENSE TRANSFER: License transfer is possible and will be considered as an amendment.
AUTHORIZED REPRESENTATIVE: Foreign manufactures must appoint a legal authorized representative (AR) that is located in Costa Rica, and will be responsible for the registration process.
ADDITIONAL INFORMATION: According to Decreto 403902-S Biomedical Equipment and Material. Classification, Registration, Importation, Labeling, Advertising, Surveillance, And Control will be effective on September 9, 2023; all Class I EMBs do not require any more sanitary registration for commercialization and use, but they are subject to import, labeling, advertising, surveillance, and control requirements.
Other Central America and the Caribbean Countries: Belize, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama
