Mexican Registration Holder Ultimate Guide

If you are evaluating a medical device for the Mexican market you are already selling through a distributor or using a registration holder, this guide will help you to understand:

We also advise reference to our guide for regulatory affairs in Mexico. This will provide a better sense of the overall regulatory process. In addition, our classification and grouping guide is the
best way to understand the first steps you can take for an excellent experience in the Mexican medical device sector.

stkhldrs

The stakeholders in a regulatory project in Mexico.

In this section, we will provide a better understanding of your legal responsibilities and/or common roles in a project. These could be:

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 the Mexican norm NOM-241).

Common role in a regulatory project

They can play the role of a Holder since they are located in Mexico. Even though, most of the times the manufacturer is a third party manufacturer and the legal manufacturer is located outside Mexico, then the third party manufacturer only provides the good manufacturing practices certificate from the Mexican Ministry of Health.

Holder in Mexico

Legal responsibilities

The ministry of health considers the holder as the main responsible for any affair related to the medical devices the holder owns. The holder is also responsible for complying with local warehouse regulations. In addition, it 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 the Mexican norm NOM-240).

Common role in a regulatory project

The holder submits the paperwork and keeps a communication channel with the manufacturer to inform any adverse incidents.

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 throughout the regulatory project like peer-review.

Local Distributors

Legal responsibilities

If they are not the holders and are mentioned in the sanitary registration as importers or distributors, the local distributor responsibilities are the same as the holder except they are not the main point of contact with 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 references to this area.

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. An option if you want to have timeframe certainty or agile feedback.

At this point you hopefully have a better understanding about the holder and other players involved in the regulatory process. As you can see, it does not matter how many participants are related to a medical device, the solely point of contact to the ministry of health in Mexico is the registration holder. In addition, as we have mentioned the holder must be compliant with the local warehouse regulation as well as with the technovigilance program. In the next section we will explain in greater detail what this means and your role.

What this holder must have and know

Well, you already know that the holder must have a compliant warehouse. As mentioned in our guide for regulatory affairs in Mexico, there are two documents that set the warehouse requirements:

NOM-241. Medical device good manufacturing practices
  • Details every requirement to be certified in Mexico for good manufacturing practices. It is also applicable for warehouses.
  • It is not required if you are exporting to Mexico. This is applicable, for companies settled in Mexico and manufacturing a medical device domestically. Please keep in mind, it is important to check first if your product is a medical device or not.
Supplement for health supplies1
  • The Pharmacovigilance National Center 2 is in charge to prepare and update this document. This is the gold standard reference for every medical device warehouse to understand what it is required to properly operate a warehouse in Mexico.
If you have the opportunity to read both documents, you will find that some requirements are repeated or some are only mentioned in one, but not in the other. This is because the NOM-241 (for good manufacturing practices) is intended for manufactures, even though it also covers warehouses. On the other hand the supplement for health supplies establishments is focused on warehouses. Unfortunately, both are applicable to the holder in an audit. In reference to audits, it may appear that the ministry of health must audit the holder to receive an authorization to legally warehouse medical devices. This is not totally true. The way it works is that the holder requests a notice3 from the ministry of health. This only means that the ministry of health assumes (without visiting the holder) that the warehouse is compliant. Nevertheless, as of the time the holder submits this notice, the approved warehouse is subject of an audit. In the case that your holder receives an audit, the ministry of health releases a report detailing any nonconformities. In such a case, if those nonconformities are not solved, the warehouse can be shutdown. Unfortunately this means that the sanitary registrations under the holder’s name will be banned as well. Keep this in mind when you are working with a holder.

Technovigilance

In addition to the two mentioned legal references (NOM241 and the supplement), the holder is also responsible for the technovigilance program. Technovigilance is similar to a surveillance program in other countries. All the details about this program are mentioned in the Mexican official norm (NOM):

NOM-240. Technovigilance program

A few concepts considered useful in order to understand the technovigilance program are:

Adverse incident4
This is any incident that is related to the medical device.
Notification
This can be a bit tricky. Notification means any formal communication to the ministry of health.
  • If it is the first event, it is called an initial notification5
    .

Then, if the holder submits an initial notification, it is necessary to present two more notifications:

  • A second one that is called a following report6.
  • And the last one that is called a final report7.
Technovigilance information8
This is different from the notification. This information is presented to renew your sanitary registration. This happens every 5 years (the time your sanitary registration expires). The technovigilance information is a summary of any incident and imported products related to the medical devices of the sanitary registration you want to renew.

Then, if the holder receives any information related to an adverse event the holder must analyze it and notify the ministry of health. It is worth mentioning that not all the events are notifiable. Most of the time this is because the medical device was used inadequately and outside the expected risk evaluation. For example, if a surgical instrument is used in a way that is totally outside the intended framework of use or without the expected risk analysis.

At this point, we know what the holder should do, but what if you are not the holder. A common question from our clients is what their role is within the technovigilance program. Using as a reference the players we mentioned at the beginning of this guide, we have:

Manufacturer located abroad or in Mexico
  • The manufacturer must inform the holder about any adverse incident in or outside Mexico related to the medical devices the holder represents.
Holder in Mexico
  • Responsible for the technovigilance program. This includes notifying the authorities about any adverse incident as well as submitting the technovigilance information.
Independent Regulatory Affairs Consultant Firm
  • No obligation (if not the holder).
Local Distributors
  • If those are mentioned in the sanitary registration, they must inform the holder about any adverse incident in Mexico related to the medical devices the holder represents.
  • If they are not mentioned in the sanitary registration, they should inform to the ministry of health about any adverse incident.
Third Party Reviewers
  • No obligation.
Any Other
  • Inform the ministry of health about any adverse incident.

As you can see the holder plays a major role during the lifespan of your medical devices in Mexico.

In addition to these obligations, the Mexican registration holder also:

  • Participates with local distributors to provide signatures related to public bids. This is because the entity that legally owns the registrations in Mexico is the holder.
  • Receives direct calls from public departments to know more about the medical device they legally represent. This is something that you would want to know as manufacturer.
  • Must have a sanitary responsible. This is the highest authority in the warehouse and the person who signs every document related to sanitary matters.

In conclusion, the Mexican registration holder is a key partner for you as not only a legal representative, but also as an important stakeholder during the technovigilance processes.
At this point, you should now be more familiarized with how the holder must be compliant. We suggest checking if the holder is knowledgeable about his obligations. In our experience, there are areas of opportunity than can be covered on time and save your registration of a potential risk.

References

1Suplemento para establecimientos dedicados a la venta y suministro de medicamentos y demás insumos para la salud.

2 Centro Nacional de Farmacovigilancia.

3 Aviso de funcionamiento.

4Incidente adverso.

5Notificación inicial.

6Reporte de seguimiento.

7Reporte final.

8Informe de tecnovigilancia.

stkhldrs

The stakeholders in a regulatory project in Mexico.

must-know

What this holder must have and know

technovigilance

Technovigilance

Mexican Registration Holder Ultimate Guide

If you are evaluating a medical device for the Mexican market you are already selling through a distributor or using a registration holder, this guide will help you to understand:

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