Medical Device Registration and Approval in Costa Rica
General country-specific regulatory information is provided on this page for medical device registration and approval in Costa Rica.
Last updated on November 5th, 2021.
Medical Device Regulations and Classification in Costa Rica
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.
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