Classification and Grouping Ultimate Guide.

As in any other country, the ministry of health in Mexico classifies medical devices in different groups based on their level of risk. In addition, the Mexican authorities have established grouping criteria that allow the allocation of similar products in the same sanitary registration. In this guide we present a thorough explanation of the classification and grouping criteria. You can find this information in the Supplement of Medical Devices1, published by the Mexican Pharmacopeia (FEUM)2.

Is my product a medical device?

The first question you have to ask before initiating a classification is if your product is considered a medical device in Mexico. Fortunately, in most cases, this is not a complicated task to solve. Specifically, the ministry of health has released an agreement that lists all the low risk medical devices and those products that are not considered medical devices3. This document is official and allows to easily identify if your product is not a medical device or a class I low risk. Then if your product is included in the non-medical device list, you do not have to do anything else, at least in regulatory terms. Nevertheless, we strongly recommend following the advice provided in our ultimate guide for regulatory affairs in Mexico – we offer a few suggestions to eliminate potential risks. To close this section, we frequently receive questions about accessories. This is a hot topic when accessories are included with a medical device raising questions like:

Our advice is: If you have identified your product or any accessory as a medical device, then perform a grouping criteria evaluation (more in the next section). This will help you to separate every product and accessory by group of medical devices. The rest of the non-medical devices should be mentioned in the sanitary registration. Be careful with this last statement, we do not mean you have to mention every screw, but the pieces that you generally send to customers as replacements should be included.

Grouping

At this point you have strong evidence that your product or products might be medical devices or that some are properly classified as medical devices and others not (like accessories). In other words, you have strong evidence because your product is considered a medical device in the country of origin and it is not included in the Mexican list of non-medical devices.

Then, the next step we recommend to do is a grouping assessment. This will help you to make a deeper evaluation if your product (and accessories) can be grouped in the same registration.

For such an endeavor, the ministry of health details the grouping criteria based on medical device types. Specifically:

Before going in depth with each section, you may feel disappointed if your product is not mentioned in these sections. Don’t worry, you can still use the general grouping criteria summarized in these simple rules:

Note: This is applicable in the following sections even if it is not mentioned (unless something different is clearly stated).

In-Vitro Diagnostics (IVDs)

We know there are thousands of IVDs in the market. You can find them in different presentations, sold in kits or measuring the same parameters but with different principles. The authorities try to simplify the most common scenarios for products sold in kits and quick tests.

IVDs sold in kits

You can include in the same registration the reactants, controls, calibrators, buffer solutions or solutions if all of them are intended to diagnose the same parameters under the same analytical method.

Quick tests

Quick tests, such as pregnancy tests, glucometers, etc. Those can be grouped in the same registration if they share the same presentation. For example, strips, cassette, pens, etc.
For drug or alcohol tests. These can be grouped in the same registration even if you measure different types of drugs, as long as they have the same presentation.
For glucometers and diagnostic equipment, the strips, controls and calibrators can be grouped as long as they have the same intended use. Lancets and glucometers each require a separate registration. In other words, you have to register separately:

Once the products are approved, you would request a single registration (as a kit).

Comments: In case your products are not included, use the general grouping criteria (referred to at the beginning of this section) to make a more educated assessment.

Surgical instruments

In this case, if you are a surgical instrument manufacturer, we are sure your catalogues have at least 50 pages. This is because you have different sizes and small variations for products with the same material (or different). You can also be an orthopedic manufacturer that sells the instruments along with your implants (a common practice in the market). Fortunately, there are some specific rules for such cases.

For surgical instruments, you can group them in the same registration if they have the same intended use or are intended for the same surgical procedure.

If the instruments are intended to place a prosthesis, they can be grouped as a kit (separately from the prosthesis) as long as they share the same indication.

If you have a set of instruments having the same material and intended use. Different presentations and models can be grouped in the same registration

Surgical materials and wound care related devices

In this case we have two rules:
You can group in one registration surgical materials or wound care related devices if they have the same material, formulation or composition, and intended use such as catheters or sutures.
You can also group in the same registration systems that have the same indication. A good example is a hip implant replacement system.

Medical equipment

For medical equipment, you can group in the same registration the accessories and components that are part of the medical equipment. Even though it is not mentioned in the guidelines, we have had several cases that where accessories that are implantable were rejected. In other words, if you have an implantable accessory (let’s say a vaginal transducer) you have to register it separately.
You can group different models, presentations or sizes as long as they have the same technology, indication and intended use.

Conclusion

Medical devices in Mexico are regulated by COFEPRIS, a Federal Commission that belongs to the Ministry of Health.

In this section, we want to give you a quick overview of what it means to get a document into COFEPRIS and the commissions involved. Once you know this, it will be easy to understand why you are submitting letters to a certain commission or what your regulatory consultant must do to properly submit and receive documents.

The first step is to program a meeting to get your documents submitted. This must be done in person for many processes, but not for all of them. For instance, import permits can be submitted electronically. This is not the case for a new registration submission. 

Once you have formally submitted, the Sanitary Authorization Commission is in charge to review and approve your request. Then, every letter you submit must be addressed to the Sanitary Authorization Commissioner in turn.

It is also of interest that the Sanitary Operation Commission is in charge of auditing your warehouse or any facility if located in Mexico.

References

Suplemento de Dispositivos Médicos.

Farmacopea de los Estados Unidos Mexicanos (FEUM).

Acuerdo por el que da a conocer el listado de insumos para la salud considerados como de bajo riesgo para efectos de obtención del Registro Sanitario, y de aquellos productos que por su naturaleza, características propias y uso no se consideran como insumos para la salud y por ende no requieren Registro Sanitario.

Acuerdo por el que se dan a conocer los trámites y servicios, así como los formatos que aplica la Secretaría de Salud, a través de la COFEPRIS.

classificationss

Is my product a medical device?​

grouping

Grouping

invitro

In-Vitro Diagnostics (IVDs)​

surgical-instr

Surgical instruments​

wound-inst

Surgical materials and wound care related devices​

medical-equipment

Medical equipment​

Classification and Grouping Ultimate Guide

As in any other country, the ministry of health in Mexico classifies medical devices in different groups based on their level of risk. In addition, the Mexican authorities have established grouping criteria that allow the allocation of similar products in the same sanitary registration.

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