In Veraque we are interested in providing you with the latest news and detailed information about regulatory and quality affairs in Mexico. This is a great resource, in case you are looking for an indepth description of the full regulatory process in Mexico. For a general overview you can check our website for each of the services we provide or contact us directly. We would be glad to send the information you are looking for. Also, if you are still not sure if your product is a medical device, we invite you to check our ultimate guide for classification and grouping. This is a great reference for the first step you want to take in the Mexican market.
You can check any chapter independently if you are looking for a specific topic.
Finally, to keep things as easy as possible, we place every translation to Spanish in the footnotes.
We encourage you to use these translated terms if you are looking for a specific term in the
internet. Please note that the Spanish-English translations we use in this document are not official
Once you have identified if your products are medical devices, you may want to start preparing all the paperwork to receive a sanitary registration. However, you now need to know which documents are necessary and who requires you to present them. As in any other country, these requirements are generally based on a legal framework. In this guide we want to provide a quick introduction about the main legal references that will help you to bolster your dossier (the set of documents you will need to submit to the local authority).
The legal and/or real manufacturer does not have any legal binding with the ministry of health in Mexico.
They supply the necessary paperwork for the ministry of health. Please keep in mind that only Mexican legal entities can submit documents to the ministry of health. Therefore, the manufacturer requires a representative (a holder).
The manufacturer must be compliant with the local good manufacturing practices (based on NOM-241).
They can play the role of a Holder since they are located in Mexico. However, usually the manufacturer is a third party and the legal manufacturer is located outside of Mexico, then the third party manufacturer only provides the good manufacturing practices certificate to the Mexican Ministry of Health.
The ministry of health considers the holder as the
responsible party for any affairs related to the medical devices the holder owns. The holder is also responsible for complying with local warehouse regulations. In addition, the manufacturer must have a Sanitary Responsible who oversees all the operations in the local warehouse. Finally, the holder is also responsible to
maintain the technovigilance program (based on NOM-240). More details are covered in our registration holder ultimate guide.
The holder submits the paperwork and maintains a communication channel with the manufacturer to inform him about any adverse incident.
If they are not the holders, they do not have any legal responsibility.
They can play a role as your holder or help you in some processes during the regulatory project such as peer-review.
If they are not the holders and are mentioned in the sanitary registration as importers and distributors, the local distributor responsibilities are the same as the holder, except they are not the main point of contact to the ministry of health. In other words, the local distributor is subject to receiving audits to its warehouse and is required to have a Sanitary Responsible and report any adverse incident.
They can play a role as your holder and/or commercial activities. Please check our registration holder ultimate guide for more information about this.
These are COFEPRIS approved entities that deliver a pre-approval. COFEPRIS considers this pre-approval as a proof that another expert has evaluated the dossier resulting in an expedited review and response. This was an option a few years ago to provide time certainty. Nevertheless, this is no longer the case and we do not recommend to use this alternative.
At this point, we have identified the rules and specific documents that lay behind every medical device sold in Mexico. In addition, we have identified the main stakeholders in a regulatory project, detailing the COFEPRIS departments related to your paperwork assessment. Now, it is time to talk in detail about the routes you can choose. It is worth mentioning that you may want to check our ultimate guides for classification and grouping and Mexican registration holder to know more about the first steps to take and the role of your holder in Mexico.
As in any country, we have to start with the medical device classification and grouping to identify the best regulatory pathway. Then, once you have achieved the classification and grouping assessment, you will end up with the following options:
This may sound complicated, but you only have to check first which options are available for you. Then, balance time and requirements between options. What we consider important to point out is that the third party option is never eligible if you have decided to work before with the equivalency route.
At this point, you now know the classification of the product and the pathway you want to follow.
We want to end this section by describing the processes you can do or have to do with your sanitary registration in Mexico:
We have talked a lot about the timelines. In an effort to make this easy for you, this is a summary for different pathways and processes. Please consider that none of them is based on legal information but rather on our experience throughout the years. In addition, this time is based upon submission of your documents to COFEPRIS.
We offer some useful references you can check in the internet. You can use an automatic translator to have a better understanding of these documents. If this is not sufficiently clear or difficult to access for information feel free to contact us with any questions, and we will be glad to help you.
For any legal framework review. If you have the name in Spanish of the legal document you are looking for, type it in an internet search engine and check if it directs you to the Official Mexican Diary webpage, this is the most trust-worthy reference you may have.
The legal Pharmacopeia offers general reference for any supplement you may be interested in. Keep in mind that accessing these documents has a cost.
1 Ley General de Salud.
2 Ley Federal de Procedimiento Administrativo.
3 Reglamento de Insumos para la Salud.
4 Normas Oficiales Mexicanas (NOM)
5 Acuerdo por el que se reconocen como equivalentes a los requisitos establecidos en los artículos 179 y 180 del reglamento de insumos para la salud […]. The MHLW and FDA/HC are separate agreements.
6 Acuerdo que establece la clasificación y codificación de mercancías y productos cuya importación, exportación, internación o salida está sujeta a regulación sanitaria por parte de la Secretaría de Salud.
7 Acuerdo por el que la Secretaría de Economía emite reglas y criterios de carácter general en materia de Comercio Exterior.
8 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.
9 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.
10 Suplemento para establecimientos dedicados a la venta y suministro de medicamentos y demás insumos para la salud.
11 Centro Nacional de Farmacovigilancia.
12 Suplemento para Dispositivos Médicos.
13 Comisión Federal para la Protección contra Riesgos Sanitarios.
14 Comisión de Autorización Sanitaria.
15 Comisión de Operación Sanitaria.
16 Escrito libre.
In Veraque we are interested in providing you with the latest news and detailed information about regulatory and quality affairs in Mexico. This is a great resource, in case you are looking for an indepth description of the full regulatory process in Mexico.