Based on our databases, Mexico has +2,000 distributors with more than one Sanitary Registration (including Holding companies) and +100 owning more than one hundred. From all that universe of distributors (+5,000), it is difficult to estimate the sub-distribution, since none of them are considered in public databases.
Considering the number of distributors with sanitary registrations, the question is if you are limited to that set of approximately +5,000 local distributors in Mexico. In this article, we will explain that it is possible to assign any entity located in Mexico as a local distributor; in the meantime, it complies with sanitary regulations. In addition, we will discuss when it is the ideal scenario to choose one.
As referred in our Regulatory Affairs guidelines, the distributor is generally the entity that imports and distributes medical devices in Mexico. They can also be considered the Holders of the Sanitary Registrations. In other words, as Holders, the distributor is the legal owner of the Sanitary Registrations.
Nevertheless, the distributor does not necessarily have to be the Holder of the Sanitary Registration. An alternative is to work with Holding service companies. These entities are the legal representatives on behalf of Medical Device manufacturers without any importation/distribution activity –unless the Holder specifies it.
Then, the local distributor can be your Holder or not. In any case, that local distributor must always be compliant with local sanitary regulations. For instance, these entities must have a medical device compliant warehouse, follow a Technovigilance program and others. For more details, you can check this article. The main point is that the legal document stating that the distributor has a medical device warehouse is the so-called Warehouse Notice (Aviso de Funcionamiento).
The Warehouse Notice is a document stating that the distributor has a Medical Device warehouse in Mexico. It also implies that is complaint with the local regulations. In other words, to get this Notice, the local authorities do not audit the company but can eventually do it. This is a key fact to consider since any company can get a Warehouse Notice, even if they do not have a complaint space for it.
Based on this, when you are looking for a local distributor, we strongly recommend asking for the Warehoue Notice (Aviso de Funcionamiento), and also some evidence that the distributor complies with local regulations (e.g. show more details about their Quality Management System, who is the Sanitary Responsible, etc.)
Now that we understand what a local distributor needs to operate legally in Mexico, the next question is when it is the best moment to choose it. Based on our experience, the best moment to choose a distributor is before starting any regulatory process in Mexico. More specifically, in order to import and distribute any Medical Device in Mexico, the local distributor must be mentioned in the Sanitary Registration. There are two ways to do it:
- Upon the first submission of the paperwork to get a Sanitary Registration.
- Through an administrative modification.
If it is the first time you submit documents to the Ministry of Health in Mexico, you can identify the local importers/distributors to be mentioned in the Sanitary Registration. Otherwise, you have to wait until you receive the Sanitary Registration and submit a modification. That being said, the best moment to include an importer/distributor is upon the first submission to get a Sanitary Registration. Otherwise, you have to wait time to amend it.
Finally, it is worth mentioning that sub-distributors are not generally mention in the Sanitary Registration, because these companies mainly buys products to the local distributors listed in the Sanitary Registration. Another point to keep in mind, is that choosing a local distributor as your Holder, implies that only one distributor will be mentioned in the sanitary registration. In other words, that distributor (the Holder) will not generally allow other competitors to be mentioned in the Sanitary Registration. That is when Holding service companies can help you to solve that problem.
In conclusion, we strongly recommend evaluating your local distributor through its Warehouse Notice. In addition, the best moment to identify them is before starting any regulatory process in Mexico. Otherwise, you may need to wait to amend the sanitary authorizations.
If you have any question about this process or need to find local distributors in Mexico, feel free to contact us at contact@veraqueconsulting.com
