{"id":2863,"date":"2022-07-13T16:43:42","date_gmt":"2022-07-13T16:43:42","guid":{"rendered":"https:\/\/veraqueconsulting.com\/co\/?p=2863"},"modified":"2025-07-04T17:45:22","modified_gmt":"2025-07-04T17:45:22","slug":"classification-and-grouping-for-surgical-instruments-in-colombia","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/co\/classification-and-grouping-for-surgical-instruments-in-colombia\/","title":{"rendered":"Classification And Grouping For Surgical Instruments In Colombia"},"content":{"rendered":"

As mentioned in our\u00a0Classification and Grouping Ultimate Guide<\/strong><\/a>, there are a series of rules to consider when classifying and grouping medical devices. The above-mentioned rules are fully explained in the decree 4725 of 2005 by INVIMA.<\/p>\n

 <\/p>\n

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.<\/p>\n

\u00a0<\/strong><\/h3>\n

General characteristics of Surgical Instruments<\/strong><\/h3>\n

 <\/p>\n

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).<\/p>\n

 <\/p>\n

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.<\/p>\n

 <\/p>\n

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

\u00a0<\/strong><\/h3>\n

Classification according to the level of risk<\/strong><\/h3>\n

 <\/p>\n

Surgical instruments by their nature are classified as Class I<\/a><\/strong> medical devices in Colombia. Nevertheless, they will be considered Class IIa<\/strong> if sold for single use.<\/p>\n

\u00a0<\/strong><\/h3>\n

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

 <\/p>\n

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 the same:<\/p>\n

 <\/p>\n