Frequently Asked Questions
Is ISO 13485 required in order to register in Mexico?
Technically no, but companies must provide proof of an audited quality system in order to register in Mexico. Most manufacturers provide their ISO 13485 certificate, however, a quality system certificate issued by a government agency, such as the Korean Ministry of Food and Drug Safety (MFDS), would be accepted.
In 2012, COFEPRIS introduced the option of third party reviewers (TPR). Through this option, companies can pay a TPR, which are independent, accredited commercial entities, to “pre-approve” medical device applications. Third party reviewers are local Mexican companies and are not associated with any globally recognized registrars/notified bodies. They will review the dossier in detail, often requesting more information from the manufacturer before issuing their pre-approval letter. COFEPRIS will then complete a final review and issue the registration certificate.
Can Emergo recommend a third party reviewer to me?
If selected as your registration holder, Emergo will actually need to contract with the TPR on your behalf. As a part of this process, we’ll provide feedback on the reviewers that we have worked with as well as their pricing, so that you can make an informed decision. We will also help in communicating with them throughout the process.
The “fast track” process, also known as the Equivalency process, is a regulatory route available to companies that have “approval” in Canada, the US, and Japan. Companies must also meet other route-specific requirements, such as having been inspected by the FDA with an inspection report available. This was introduced in late 2010 as another way for COFEPRIS to manage their tremendous backlog in device reviews by minimizing the amount of technical data companies had to provide, as well as provide some comfort that the products had already undergone a rigorous review through a credible regulatory authority.
A fair amount of technical information is still required for this route; however, the application review is simplified. When initially implemented, approvals were issued extremely quickly in comparison to the “standard” process; however, as time goes on, this timeline has also crept upward. The fastest method at the moment is the TPR system mentioned above.
It is as important as device classification. The family grouping impacts the number of registrations you must complete, which can certainly impact your costs and timeline. For example, devices which might be grouped in one registration in a market such as Europe commonly require multiple registrations in Mexico. This adds to the time and cost of your registration project.
Family grouping depends on factors such as intended use (implants for shoulders may not be grouped with implants for knees), raw materials (stainless steel may not be grouped with aluminum) and other factors. Emergo has the experience to help you define a grouping strategy to make the most of your time and budget.