When registering Medical Devices in Colombia, the classification and grouping strategy is a key activity for optimizing the number of registrations (based on 18 rules).
You can find some examples of the classification and grouping criteria in our previous articles for:
In this article, we will explore the classification and grouping for Urology devices to be registered in Colombia.
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.
The following examples illustrates 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, meatal dilators, penile clamps.
- Prosthesis: penile prosthesis, artificial urinary sphincter, ureteral stent.
Classification according to the level of risk
There are different characteristics of urology related devices that may affect its level of risk (materials, technology, and duration of use). Here some examples using some of the products mentioned above:
- Lithotripter: depending on the technology used, it can be classified as Class I by Rule 5 (mechanical lithotripter) or Class IIb by Rule 9 (laser or shockwave lithotripsy).
- Ultrasound: noninvasive active medical device, generally classified as Class IIa by Rule 10.
- Endoscope and ureteroscope: are considered as invasive, short-term devices and classified as Class IIa by Rule 6.
- Catheters: intermittent catheters and other catheters for surgery are short-term and can be classified as Class IIa by Rule 7, indwelling urinary catheters also known as Foley catheters can be classified as Class IIa or IIb by Rules 7 and 8.
- Drainage bags: typically considered as Class I by Rule 1.
Grouping 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.
- All models have the same trademark.
- 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.
Conclusions
Urology medical devices comprise a wide range of products with different classifications according to their intended use and level of risk that can also be grouped for registration purposes. If you need support registering Urology medical devices, please contact us at contact@veraqueconsulting.com.
