Bringing hemodialysis technology to the Mexican market requires a strategic look at how dialysis machines and their specialized accessories (such as dialyzers, tubing, and needles) interact under COFEPRIS regulations.
While these devices must adhere to Mexico’s general classification criteria, the complexity of dialysis systems creates unique challenges for manufacturers during the COFEPRIS submission process. In this guide, we move beyond the general guidelines to explain how to apply grouping logic specifically to renal care portfolios to ensure a successful sanitary registration.
General characteristics of a Dialysis machine
Dialysis machines are used as part of a Hemodialysis procedure to clean the patient blood when kidneys are not properly working. These machines work with several accessories, the most common are:
- Dialyzer. Also known as an artificial kidney. This is a filter with a membrane that separates the waste product in the blood.
- Fistula needle sets. The Fistula or arteriovenous (AV) fistula is a connection between an artery and a vein to promote a stronger vessel to get access to periodic Hemodialysis treatments. Fistula needles are used to get access to the fistula.
- Tubing set. These are all the connections generally divided in arterial and venous lines to carry the blood from the artery to the machine and way back to the vein.
- Bicarbonate. In certain procedures, bicarbonate is used to control metabolic acidosis and is an alternative presented in bags or cartridges.
How Dialysis Machines are Classified in Mexico
Dialysis machines are classified as medical equipment and due to their level of risk are considered Class II. It is worth mentioning that we have found precedent Dialysis machines as Class III medical devices. Nevertheless, in the latest supplement of the pharmacopeia (referred at the beginning of this article), it is clearly stated that those devices intended to filter blood will be considered class II. Such note was not clear before the latest amendment to the supplement and generally creates controversy on this classification.
On the other hand, all the tubing and needle sets will be considered as class II medical devices. Regarding dialyzers and bicarbonate, both are also considered class II medical devices. As with the Dialysis machines, dialyzers also have precedence as class III medical device but since the same classification rule is applicable, class II is a better approach.
As a final note about the classification, some companies still prefer to register any of these devices as class III to keep a safer regulatory pathway. Such strategy is still valid and do not have a considerable impact in timelines or paperwork documentation, but basically on the Ministry of Health fees. You can check more about this in our guidelines.
Registration Grouping Rules for Dialysis Kits & Accessories
The classification for a Dialysis machine and its accessories is basically the same (Class II). Yet, it is still necessary to consider a few points regarding the grouping criteria. Specifically for the dialyzers, which are presented in High and Low, flux models.
Regarding the Dialysis machines, if different models are presented, it is necessary to confirm that they share the same technology, intended use and manufacturer in order to group them in the same registration.
On the other hand, the tubing sets and needle sets can be intended for different machines or have different technologies for the needle. Considering a low risk grouping strategy, different needle types should be grouped in different sanitary registrations. On the other hand, we do consider that it is still safe to keep the tubing sets in the same registrations even if those are intended for different machines. Nevertheless, this last point still creates controversy and should be better evaluated for every case.
Finally, the dialyzers are generally presented in High / Low flux versions. The difference between both versions basically is due to the type of membrane. To keep a low risk grouping criteria, it is better to separate both versions in different registrations. Even though, the intended use is the same in some way, the technology is different between the membranes.
Frequently Asked Questions (FAQ): Dialysis Equipment
- What is the classification for dialysis machines in Mexico?
Under the Mexican Pharmacopeia (FEUM) Supplement, dialysis machines are generally assigned to Class II. While some historical precedents exist for Class III designations, current criteria focus on the device’s function in filtering blood, which aligns with Class II risk levels. - How are dialysis accessories classified in Mexico?
Standard accessories, including dialyzers, fistula needle sets, tubing sets, and bicarbonate cartridges, are typically categorized as Class II medical devices. - Can I group different dialyzer models in a single registration?
Grouping depends on technology and flux. While they share an intended use, COFEPRIS often requires High-Flux and Low-Flux dialyzers to be separated into different registrations because the membrane technology differs significantly between the two.
Thanks for reading this article, if you have any question about this topic, feel free to contact us at [email protected] or check our guidelines.