When registering Medical Devices in Costa Rica, the classification and grouping strategy is a key activity for optimizing the number of registrations (based on 16 rules).
You can find some examples of the classification and grouping criteria in our previous articles for:
Though, it is worth mentioning other classes of medical devices. In this article, we will focus on the classification and grouping for Urology devices to be registered in Costa Rica.
General characteristics of urologic medical devices
Urology is a specialty that uses a wide range of devices mostly for diagnostic and surgery. Thus, based on their intended use, urology devices are generally classified as surgical materials and wound care related devices. Nevertheless, we can find similar products categorized as medical equipment, prosthesis or functional aids.
Examples to illustrate this situation very well:
- Medical equipment: Lithotripter, ultrasound, endoscope, and ureteroscope.
- Surgical materials and wound care related devices, catheters, wires, guides, surgical instruments.
- Functional aids: intermittent catheters, drainage bags, metal dilators, penile clamps.
- Prosthesis: penile prosthesis, artificial urinary sphincter, ureteral stent.
Classification according to the level of risk in Costa Rica
There are different characteristics of urology related devices that may affect their level of risk (materials, technology, and duration of use). Some examples using some of the products mentioned above are:
- Lithotripter: depending on the technology used, it can be classified as Class 2 by Rule 2 (mechanical lithotripter) or Class 3 (shockwave or laser lithotripsy).
- Ultrasound: active medical device intended for diagnostic, generally classified as Class 2 by Rule 10.
- Endoscope and ureteroscope: are considered as invasive, short-term devices and classified as Class 2 by Rule 2.
- Catheters: intermittent catheters and other catheters for surgery are short-term and can be classified as Class 2, indwelling urinary catheters also known as Foley catheters can be classified as Class 3.
- Drainage bags: typically considered as Class 1 by Rule 7.
Grouping of Urology Devices for Sanitary Registration purposes
Some Urology products can be grouped in the same registration considering the following points:
- Devices are made by the same manufacturer.
- Same indication of use for all devices grouped.
- Same materials (including coatings for catheters).
- Surgical instruments can be grouped as kits.
- Accessories can be included in the registration for medical equipment.
- Lubricant for catheters can be included in the same registration.
- Surgical instruments to place prothesis can be added to the registration.
- More than one presentation can be included in the same registration, in which case all the presentations must be indicated in the application.
Conclusions
Urology medical devices encompass a diverse array of products, each classified based on their intended use and associated risk level. These devices can also be strategically grouped for registration. If you require expert guidance in registering urology medical devices, feel free to reach out to us. at contact@veraqueconsulting.com.
