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.