What is Regístrelo and how does it work?
Paperwork and processes to register a medical device worldwide could be considered complicated. In addition, the timelines necessary to evaluate such documents might demotivate manufacturers around the globe. Fortunately, and recognizing the need to simplify and make the entire process more agile, Ministries of Health in different countries have developed functional and technological platforms on the web.
One of these countries is Costa Rica, whose Ministry of Health created Regístrelo, a modern system for registration of different products including medical devices, or as the local Authority calls them, “EMB”, which stands for Equipment and Biomedical Material.
Probably the first thing that is worth saying about this system, is that it can be reviewed and consulted by any person, but only registered users will have the permission to perform submissions. Such Regístrelo users, who will be acting as representatives for any application, should have demonstrated to have an e-signature.
Another relevant characteristic of Regístrelo, is that it has the capacity to respond almost instantaneously to a wide range of operations. To give an example, an administrative modification used to take several months, but nowadays the online system takes only a few hours.
As expected, a fully digital system enhances paperless initiatives. For example, during the importation process, customs authorities, through the Foreign Trade Promoter (PROCOMER), used to require physical documentation to allow the importation of diverse goods. Instead of this process, they just have to consult the system Regístrelo and confirm, in real time, whether a specific product has been approved and if the importer has been authorized to participate in such process.
It is worth mentioning that the Regístrelo section for public consultation goes way beyond the importation activities. For instance, you can find useful features to generate reports in PDF documents or Excel spreadsheets; perform marketing research for products and/or competitors and more. We invite you to check Regístrelo and all its capabilities.
System Regístrelo is a digital platform developed by the Ministry of Health in Costa Rica that offers companies to apply for a variety of documents fully online. To maintain safety to the information received and released, Regístrelo can only be used by registered people. In addition, the system is mostly open to provide reports to any person interested in consulting information about an EMB (Medical Devices) or other products. Finally, since the results can be consulted by other Authorities (e.g. Custom agencies) in real time, the processes become much faster.
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