The criteria for grouping and classification have for a long time been a complex topic in Mexico. For many years the ministry of health released on its webpage two guides to understand the classifications and groupings for medical devices. The main problem is that those guides were a mere reference and the authority maintained a subjective decision in reference to all grouping. This was in part due to the vagueness of the guides’ descriptions and sometimes with an argument that the classification and grouping criteria were only that: “guides”.
To tackle such disputes, the Mexican Pharmacopeia (FEUM) introduced updated guides in the Supplement of Medical Devices as an Appendix. In its latest version we can find more details to make a better assessment when you need to classify and group your products. This is the first step we recommend to do. Otherwise, you may end up with an incorrect classification which means incurring extra fees and submitting more documents if the classification is higher. In addition, if the groups you choose to include in one registration are not acceptable, the ministry of health will simply reject your grouping and request that you start the process from scratch. Both scenarios represent a waste of time and money.
To close this section, it is worth mentioning that these are still just guides, but at least as they are included in the supplement of medical devices, do provide a reference for the ministry of health. Even though you will find some discrepancies in different legal sources in the law, the supplement is your best reference. You can check our ultimate guide for regulatory affairs in Mexico for more details.
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.
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).
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.
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, 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.
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
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.
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.
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.
1 Suplemento de Dispositivos Médicos.
2 Farmacopea de los Estados Unidos Mexicanos (FEUM).
3 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.
4 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.
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.