The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
The Costa Rican government's "Digital Government" program (link in Spanish), already implemented at some ministries, is expected to be ready at the Costa Rica medical device registration and approvalMinistry of Health in October 2013. Following final implementation of the platform in early 2014, medical device manufacturers seeking market authorization in Costa Rica will be able to submit registration applications online from any location at any time; currently, registrants must submit applications in person Monday through Friday only.
"This move should improve internal processes at the Ministry of Health and cut down on time frames and costs," says Rocio Fallas, Emergo Group's Regulatory Affairs Manager based in San Jose. "Once the online submission platform is up and running, the process should be more efficient for registrants."
Emergo Group will provide further details on the Costa Rican Ministry of Health's digial submission program for medical devices as they become available.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.