When registering Medical Devices in Mexico, the classification and grouping strategy is a key activity for optimizing the number of registrations (based on 23 rules).
You can find some examples of the classification and grouping criteria in our previous articles for:
Though, it is worth to mention other classes of medical devices. In this text, we will explore the classification and grouping for Urology devices to be registered in Mexico.
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 its 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 II (mechanical and electrohydraulic lithotripsy) or Class III (laser or shockwave lithotripsy) by Rule 10
- Ultrasound: noninvasive active medical device, generally classified as class II by Rule 10
- Endoscope and ureteroscope: are considered as invasive, short-term devices and classified as class II by Rule 5.
- Catheters: intermittent catheters and other catheters for surgery are short-term and can be classified as Class I or II, indwelling urinary catheters are Class III by rule 5.
- 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 its intended use and level of risk that can also be grouped for registration purposes.
It is very important to take into consideration the characteristics of each urologic device to apply the correct classification and grouping rules and avoid preventions from COFEPRIS. If you need support registering Urology medical devices, please contact us at contact@veraqueconsulting.com.
