Background
A US Medical Device manufacturer requested regulatory support to register their products and obtain a Free Sale Certificate in Costa Rica. The company manufactures 17 medical devices between their two different manufacturing facilities.
Approach and Solution
ECI local regulatory staff in Costa Rica provides in-country representation and quickly determined the appropriate medical device classifications. Based on the business needs and timeline, the most appropriate strategy was defined including company deliverables to support the registration.
Comprehensive Action
Regulatory registration strategy determined two single product families were appropriate to support registration. Four separate registrations were required for multiple product families and manufacturing sites. ECI prepared the applicable dossiers and submitted all required documentation for new product registration to the Ministry of Health. A quality review of the documentation ensured the content met with all the applicable requirements per Costa Rica Regulation.
Results
ECI submitted 17 medical devices and provided timely response to the Ministry's queries. The product registration and licenses numbers of the 4 submissions were obtained within the timeframe defined.
The Free Sale Certificates were prepared and requested by the Ministry of Health. Upon certificate issuance, legalization and apostille will be completed.
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