{"id":3087,"date":"2025-02-04T16:34:16","date_gmt":"2025-02-04T16:34:16","guid":{"rendered":"https:\/\/veraqueconsulting.com\/cr\/?p=3087"},"modified":"2025-06-30T19:57:25","modified_gmt":"2025-06-30T19:57:25","slug":"classification-for-in-vitro-diagnostics-in-costa-rica","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/cr\/classification-for-in-vitro-diagnostics-in-costa-rica\/","title":{"rendered":"Classification for In-Vitro Diagnostics in Costa Rica"},"content":{"rendered":"

As mentioned in our <\/span>Classification and Grouping Ultimate Guide<\/span><\/b><\/a>, there are a series of rules to consider when classifying and grouping In Vitro Diagnostic devices in Costa Rica. Such rules are fully explained in Annex A.2. – Decree No. 43902-S by the Ministry of Health.<\/span>\u00a0<\/span><\/p>\n

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In this article, we will focus on explaining strategies to classify and group In-Vitro Diagnostic products (IVDs) following simple general rules and explaining some particularities that can be found in these types of devices according to our everyday experience.<\/span>\u00a0<\/span><\/p>\n

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General characteristics of an In-Vitro Diagnostic device<\/span><\/b>\u00a0<\/span><\/h3>\n

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In Costa Rica, In-Vitro Diagnostic (IVD) products are classified as Medical Devices. <\/span>The Ministry of Health<\/span><\/a> outlines their classification in Decree No. 43902-S, which also classifies other Medical Devices. However, there are nine specific rules that apply solely to IVDs, detailed in a distinct section of Appendix A.<\/span>\u00a0<\/span><\/p>\n

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IVDs are generally comprised of reactants, controls, calibrators and equipment or devices on which the diagnosis is performed. The evaluated parameters or analytes through these IVDs are many and each diagnosis process varies depending on different factors, such as: the technology, the analytical measurement technique, the type and size of the sample and the expected accuracy\/precision. All these variables must be considered during the classification and grouping evaluation.<\/span>\u00a0<\/span><\/p>\n

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It is worth mentioning that IVDs can be part of a medical diagnosis equipment and sold together with it, but in terms of their regulatory treatment they are considered as independent medical devices. A glucometer is a good example, since the device itself is considered as medical equipment and the test strips as IVDs.<\/span>\u00a0<\/span><\/p>\n

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Every point described so far has regulatory implications that we will explain in the following sections.<\/span>\u00a0<\/span><\/p>\n

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Classification according to the level of risk<\/span><\/b>\u00a0<\/span><\/h3>\n

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In-Vitro Diagnosis products are classified as follows, in general terms, according to their level of risk:<\/span>\u00a0<\/span><\/p>\n

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Class 1 IVDs (lowest risk):<\/span><\/b>\u00a0<\/span><\/h5>\n