As mentioned in our Classification and Grouping Ultimate Guide, there are a series of rules to classify and group medical devices. The above-mentioned rules are fully explained in Decree No.43902-S
This article will explain straightforward strategies for classifying and grouping CPAP (Continuous Positive Airway Pressure) systems and similar devices. We will cover general guidelines and highlight specific characteristics of these devices based on our experience in Costa Rica.
General characteristics of CPAPs (Continuous Positive Air Pressure)
In broad terms a CPAP 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) –more details in this link.
No matter the different type of device we have, most of the times they will comprise the following:
- The equipment, which is the motor and the electronics to control the air pressure.
- A mask.
- A tube that connects the equipment with the mask.
It is worth noting that accessories like tubes, masks, and even parts of the equipment itself can be sold separately. There is a wide variety of mask designs, each suited to a different intended use and offering varying levels of comfort.
Classification and Grouping in Costa Rica according to the level of risk
As mentioned, CPAPs and their variants consist of equipment, a tube and a mask. In this section, we will further talk about the classification and the grouping of these products in Costa Rica.
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 class 2 medical device.
Nevertheless, if the equipment is sold without the tube or/and mask, we must consider applying for separate registrations. For such cases, the following strategy has been proven as a satisfactory solution:
- As long as the masks and tubes are intended for the same equipment, all of them can be registered together in the same registration. The strategy is to include them as accessories for the system. This is still considered a class 2 medical device. It is worth noting that this strategy works if there is a single mask and tube.
Finally, other types of accessories, specifically those related to the equipment (e.g. spare parts) are not considered medical devices and do not need a sanitary registration. Nevertheless, we strongly advise mentioning those accessories that tend to be replaced frequently, just in case any authorities inquire about any sanitary permit.
Thanks for reading this article. If you have any questions about this topic, feel free to contact us at contact@veraqueconsulting.com or check our guides.
