{"id":3147,"date":"2024-12-16T19:31:32","date_gmt":"2024-12-16T19:31:32","guid":{"rendered":"https:\/\/veraqueconsulting.com\/co\/?p=3147"},"modified":"2024-12-16T19:31:32","modified_gmt":"2024-12-16T19:31:32","slug":"classification-and-grouping-of-cpaps-devices-in-colombia","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/co\/classification-and-grouping-of-cpaps-devices-in-colombia\/","title":{"rendered":"Classification and Grouping of CPAPs Devices in Colombia"},"content":{"rendered":"

As mentioned in our <\/span>Classification and Grouping Ultimate Guide<\/span><\/b><\/a>, there are a series of rules to classify and group medical devices. The above-mentioned rules are fully explained i<\/span>n <\/span>Decree 4725 of 2005.<\/span><\/a>\u00a0<\/span><\/p>\n

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In this article we will focus on explaining strategies to classify and group CPAP\u2019s systems (Continuous Positive Air Pressure) and equivalent equipment following simple general rules and explain some particularities that can be found in these types of devices according to our everyday experience in Colombia.<\/span>\u00a0<\/span><\/p>\n

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General characteristics of CPAPs (Continuous Positive Air Pressure)<\/span><\/b>\u00a0<\/span><\/h3>\n

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\u00a0<\/span>In broad terms a <\/span>CPAP<\/span><\/a> system (also known as a CPAP machine) is a device used to treat Obstructive Sleep Apnea (OSA) in which not enough air reaches the lungs. You can find diverse presentations as APAPs (Automatic Positive Air Pressure) or BiPAPs (Bi Level Positive Air Pressure) \u2013more details in this <\/span>link<\/span><\/a>.<\/span>\u00a0<\/span><\/p>\n

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\u00a0<\/span>\u00a0<\/span>No matter the different type of device we have, most of the times they will comprise the following:<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>\u00a0<\/span>\u2013 The equipment, which is the motor and the electronics to control the air pressure.<\/span>\u00a0<\/span><\/p>\n

\u2013 A mask.<\/span>\u00a0<\/span><\/p>\n

\u2013 And a tube that connects the equipment with the mask.<\/span>\u00a0<\/span><\/p>\n

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It is worth mentioning that accessories as the tubes, masks and the parts of the equipment may be sold separately. In particular, there is a variety of mask presentations depending the intended use and provided comfort.<\/span>\u00a0<\/span><\/p>\n

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

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As mentioned, CPAPs and its variants, are comprised of an equipment, a tube and a mask. In this section, we will further talk about the classification and the grouping of these products in Colombia.<\/span>\u00a0<\/span><\/p>\n

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\u00a0<\/span>The easiest start is the case when the product is sold all together as a system (e.g. Equipment + Tube + Mask). In this scenario, the product is generally considered as a <\/span>class IIa medical device<\/span><\/b>. Nevertheless, if the Equipment is sold without the tube or\/and mask, we have to consider to apply for separate registrations. For such cases, the following strategies have been proven as satisfactory solutions:<\/span>\u00a0<\/span><\/p>\n

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