{"id":3096,"date":"2025-02-04T18:09:05","date_gmt":"2025-02-04T18:09:05","guid":{"rendered":"https:\/\/veraqueconsulting.com\/cr\/?p=3096"},"modified":"2025-06-30T19:59:54","modified_gmt":"2025-06-30T19:59:54","slug":"classification-and-grouping-for-surgical-instruments-in-costa-rica","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/cr\/classification-and-grouping-for-surgical-instruments-in-costa-rica\/","title":{"rendered":"Classification And Grouping for Surgical Instruments 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 medical devices. The above-mentioned rules are fully explained in Decree 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 surgical instruments following simple general rules. We also detail some particularities that can be found according to our everyday experience.<\/span>\u00a0<\/span><\/p>\n

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General characteristics of Surgical Instruments<\/span><\/b>\u00a0<\/span><\/h3>\n

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Talking about surgical instruments can embrace a wide range of specialties. Nevertheless, in this article we will focus on those common supplies used in medical practice during surgery (e.g. forceps, scalpels, clamps, retractors, and scissors).<\/span>\u00a0<\/span><\/p>\n

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Manufacturers of these instruments generally manage catalogues with hundreds of models that vary in size and intended use. We have seen for years that a normal practice in the manufacturing cycle is to receive an unprocessed instrument (or the raw material) from one country and process it in another. This particular case, when the instruments are processed in different sites, is a key point to identify the real manufacturer \u2013a relevant entity in regulatory terms.<\/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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Surgical instruments by their nature are classified as <\/span>Class 1 <\/span><\/b>medical devices in Costa Rica; however, single-use surgical instruments are classified as <\/span>Class 2 <\/span><\/b>by the Ministry of Health.\u00a0<\/span>\u00a0<\/span><\/p>\n

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Grouping for Sanitary Registration purposes in Costa Rica<\/strong><\/h3>\n

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The classification for Surgical Instruments is pretty straightforward. Yet, it is still necessary to consider a few points regarding the grouping criteria. Specifically, surgical instruments can be grouped in the same sanitary registration if they have:<\/span>\u00a0<\/span><\/p>\n

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