Class 1 low risk Medical Devices in Costa Rica
As mentioned in our Classification and Grouping Ultimate Guide, there are a series of rules to consider when classifying and grouping medical devices. The above-mentioned rules are fully explained in the decree 34482-S by the Ministry of Health of Costa Rica (MoH). In this article, we will enlist the medical devices that are found in […]
Applicable standards for Medical Devices
Medical devices are a broad group of products with different characteristics. Thus, many standards have been developed to establish general and particular specifications for them. In this text, we cover the most relevant international standards that can be found in the medical device industry that are useful for regulatory purposes. ISO 13485 Medical devices […]
Regístrelo, an on-line registration system in Costa Rica.
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 […]
