Ultimate Guide for Regulatory Affairs in Mexico.

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.

To facilitate your information search, this guide details each of the following topics:

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
terms.

cofeprs

Inside COFEPRIS

Medical devices in Mexico are regulated by COFEPRIS13, 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 Commission14 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 Commission15 is in charge of auditing your warehouse or any facility if located in Mexico.
stkhldrs

The stakeholders in a regulatory project in Mexico.

If you are a manufacturer, an independent regulatory consultant, or a local distributor, it is important to understand the key roles of the main stakeholders of every regulatory project in Mexico. This will provide a better understanding of your legal responsibilities and/or common roles in a project.

Manufacturer located outside of Mexico

Legal responsibilities

The legal and/or real manufacturer does not have any legal binding with the ministry of health in Mexico.

Common role in a regulatory project

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).

Manufacturer located in Mexico

Legal responsibilities

The manufacturer must be compliant with the local good manufacturing practices (based on NOM-241).

Common role in a regulatory project

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.

Holder in Mexico

Legal responsibilities

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.

Common role in a regulatory project

The holder submits the paperwork and maintains a communication channel with the manufacturer to inform him about any adverse incident.

Independent Regulatory Affairs Consulting Firm

Legal responsibilities

If they are not the holders, they do not have any legal responsibility.

Common role in a regulatory project

They can play a role as your holder or help you in some processes during the regulatory project such as peer-review.

Local Distributors

Legal responsibilities

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.

Common role in a regulatory project

They can play a role as your holder and/or commercial activities. Please check our registration holder ultimate guide for more information about this.

Third Party Reviewers

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 can be an option if you want to have timeframe certainty or agile feedback.

pths

The routes to register a medical device in Mexico

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:

  • Class I low risk
  • Class I
  • Class II
  • Class III
  • Not a medical device
If your products are not considered medical devices, you don’t need to do any further process. Nevertheless, if the device is to be included in a public bid in Mexico, then there are chances that the bidder requires a ministry of health letter stating that the product is not a medical device. As discussed earlier in this guide, the legal framework includes a non-medical device official list. This is a key reference in case you want to defend the point. Keep in mind that distributors are the ones who participate in the bids, and it depends on their so called access department (or related) experience if your product should have such letter or not (even if your product is clearly listed in the non-medical device official list). Therefore, it might be better to check with your distributors to see if they require a letter from the ministry of health or not. In case you choose to confirm with the ministry of health if your product is a medical device or not. You have two options.
  • Prepare and submit an open inquiry16.
    • This is a letter justifying your reasons being to confirm that the product is not a medical device.
    • The process is free but does not have a clear timeline for response. Sometimes, the authority does not even respond.
  • Submit a dossier as a class I low risk device.
    • The required documents to submit for a class I low risk are minimal (more details in the section requirements for the route you choose).
    • The authority response is within a 3-6 months period and you will have a formal response either if COFEPRIS considers the device as a non-medical device or as a class I low risk, or even a higher class (class I, II or III). In other words:
      • If it is not a medical device, COFEPRIS will detail the reasons.
      • If it is a class I low risk, COFEPRIS will deliver a sanitary registration.
      • If it is a class I, II, III, COFEPRIS will inform it and require the missing documents (check the following sections for more details).

We discussed in the section “the legal framework surrounding a medical device in Mexico” that there is an agreement that lists the non-medical devices and class I low risk devices. In the last section, we talked about a non-medical device, but what about if it is included in this list as a class I low risk device. Well, we might say you are fortunate since the paperwork you have to consider is minimal. Specifically, commercial brochures, instructions for use and labels, but no technical studies. In addition, it is necessary to consider a few legal documents: a power of attorney and distribution letters. 

Finally yet importantly, you need a Holder. As mentioned in the “stakeholder in a regulatory project in Mexico”, the Holder in Mexico plays a key role for a successful experience in the country. We invite you to visit our ultimate guide about the holder role as your partner in Mexico. 

A note to conclude this section is that this is the only class of medical device that is not subject to any other route or alternative, as we will see in the options you have for class I, II and III. Don´t worry! The good news is that this is not only a process requiring few documents, but also one that receives fast responses (3-6 months).

In case you consider your product is a class I, II or III medical device in Mexico, you have three regulatory pathways. First, you want to make sure that the product has been correctly classified. In our experience, some manufacturers take for granted that if their product is a class I in their country (e.g. USA) then it should be the same classification in Mexico. This is not necessarily true and we strongly recommend doing a classification and grouping based on the Mexican laws. We invite you to visit our ultimate guide for classification and grouping for further references.

Then, when you feel comfortable with the medical device classification, you must choose one of the three regulatory pathways the Ministry of Health offers. These are:

 

1. Standard.

 

  • As its name indicates, this is the traditional route you can use. Compared with the equivalency route, the number of documents you have to present is more and it takes more time (more details in the timeframes section in this guide), both for compilation and for timeframe response.

 

2. Equivalency agreement route.

 

  • This is applicable for all medical devices approved in USA.
    • Or if it has been approved in Canada or Japan but is not class I in those countries. 
      • If it is class I, then you have to choose the standard or standard + third party routes
    • Compared with the standard process, the number of documents you have to present is less as well as the timeframe to receive a response from the authority. 



 

3. Standard + Third Party Route.

 

  • This is only applicable for new registration or any other amendment and renewal as long as the registration was not granted under the Equivalency agreement. In other words, you cannot use this option if you have previously started your process through the Equivalency agreement route.
  • But what is a Third Party Reviewer? 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. An option if you want to have timeframe certainty or agile feedback. 
  • It is worth mentioning that the requirements are the same as in the standard process. In conclusion, the advantage is that you will save time with this option.

 

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:

  • New Registration.
  • Modification.
    • Technical.
      • In case, you want to add a product or change a manufacturer. There are more options for which you can contact us for more details.
    • Administrative.
      • The most common are rights transfer or add/take off local distributors.
  • Renewals.
    • Your sanitary registration lasts 5 years.
    • 150 days before expiration, you have to submit the renewal application. In addition, you have to submit the technovigilance information 3 months prior those 150 days. Therefore, we generally recommend starting this process one year before expiration.
  • Import Permits.
    • This is applicable for some products even if they have a sanitary registration. Some implants or high-risk products are considered in this group. 
    • As with class I low risk devices, you only have one option for submission.

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:

  • New Registration.
  • Modification.
    • Technical.
      • In case, you want to add a product or change a manufacturer. There are more options for which you can contact us for more details.
    • Administrative.
      • The most common are rights transfer or add/take off local distributors.
  • Renewals.
    • Your sanitary registration lasts 5 years.
    • 150 days before expiration, you have to submit the renewal application. In addition, you have to submit the technovigilance information 3 months prior those 150 days. Therefore, we generally recommend starting this process one year before expiration.
  • Import Permits.
    • This is applicable for some products even if they have a sanitary registration. Some implants or high-risk products are considered in this group. 
    • As with class I low risk devices, you only have one option for submission.
tmlnes

Timelines

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.

  • Class I low risk: 3-6 months.
  • Class I, II, III Standard Pathway: 12+ months.
  • Class I, II, III Equivalency Agreement Pathway (if approved in USA or Canada): 6-8 months.
  • Class I, II, III Equivalency Agreement Pathway (if approved in Japan): 3-6 months.
  • Class I, II, III Standard + Third Party Reviewer: 3-6 months.
  • Administrative Modification (any pathway): 2-4 months.
  • Technical Modification Standard: 8-12 months.
  • Technical Modification with Third Party Reviewer: 3-6 months.
  • Renewals (Standard or Equivalency Agreement): 12+ months.
  • Renewals with Third Party Reviewer: 3-6 months.
  • Import Permits: 3-4 weeks.
prvntion

What is a prevention

If you have already submitted you dossier and are waiting for a response from the ministry of health, you may receive a response requesting more documents. This is what we call a prevention17 and lists the missing documents and the reasons they are missing or which documents do not suffice. Receiving a prevention does not necessarily mean that a bad job has been done, sometimes the authority requires a clearer view of what you submitted. In any case, the timeframe within which to respond is between 10-35 working days. If no response is submitted, the submission is cancelled. The question is when the clock starts for the timing. This is how it works:
  • The ministry of health informs through their webpage that you have an answer (however, you may not know if it is a prevention or not).
  • The holder must go for such response to the ministry of health facilities. Once the response is picked up the time starts running.
An important note: If you do not pick up the prevention, after some period of time the authority sends it to the Mexican Holder warehouse through standard mailbox service and the time runs once the ministry of health mails the document, not when the Mexican Holder receives it. In conclusion, your Holder must be aware of any communication from the authority, otherwise you could lose all the time you have invested so far. Now, if you respond to the prevention within those 10-35 working days, the authority will take around 3-6 months to achieve the next response. This is in general terms. On the other hand, if the response you provided is insufficient, most of the time, your submission will be rejected and you have to start over again.
refrnce

Useful references

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.

Cofepris Webpage

Official Mexican Diary

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.

Mexican Pharmacopeia

The legal Pharmacopeia offers general reference for any supplement you may be interested in. Keep in mind that accessing these documents has a cost.

References

Ley General de Salud.

Ley Federal de Procedimiento Administrativo.

Reglamento de Insumos para la Salud.

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.

17 Prevención.

legal-fw

The legal framework surrounding a medical device in Mexico

cofeprs

Inside COFEPRIS

stkhldrs

The stakeholders in a regulatory project in Mexico

pths

The routes to register a medical device

tmlnes

Timelines

prvntion

What is a prevention

refrnce

Useful references

Ultimate Guide for Regulatory Affairs in Mexico

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. 

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