In general terms, a manufacturer is defined as a company who makes products. In some industries, such as in the medical device one, the supply chains tend to be complex, considering that more than one company can be involved in the process. Such elaborated network raises questions of who is the main manufacturer and how to treat all these entities before the Regulatory Agencies.
In this article, we will explain the medical device manufacturer definition and how it is considered in Mexico. Finally, we will point out if you should mention all of these entities in the sanitary registration in Mexico and how.
In Mexico, there is not an official definition of manufacturer included in the legal framework or technical standards for medical devices. However, we can take the manufacturing process definition as a reference of how a manufacturer is considered:
A national or foreign company who is involved in the production of a medical device from the reception of the supplies, release, warehousing and distribution of the finished product.
While the above-mentioned concept of manufacturer is broad, COFEPRIS in Mexico generally recognizes the following entities:
- Real manufacturer: the company that physically performs the manufacturing of medical devices. It is also referred to the manufacturing site address or actual manufacturer.
- Legal manufacturer: a company that does not always participate in any step of the manufacturing process but is legally responsible of the manufacturing, distribution, exportation, and other activities.
- Third party manufacturer: also known as contract manufacturer, original equipment manufacturer (OEM) or outsourcing manufacturer. It is the company who fully or partly manufacturers medical devices or components for actual or legal manufacturers of medical devices and their responsibilities are established by agreements.
In Mexico, it is suggested to mention at least the figures for which the Good Manufacturing Practices (GMP) are presented for regulatory purposes and/or the Ministry of Health in the country of origin has declared as the manufacturer (either legal or real). Nevertheless, we have seen cases on which it is still necessary to explain the role of OEM’s and present as well their GMP’s (even if those are not mentioned in the sanitary registrations).
Therefore, it is important to identify the different companies involved and the role they play in the manufacturing process. This will help you to define if those can be considered in Mexico. If you have questions of how to declare your facilities in Mexico, feel free to contact us at firstname.lastname@example.org