Commonly 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), for example, would be accepted.
What are the third party reviewers (TPR)?
In 2012 COFEPRIS introduced the option of third party reviewers. Through this option, companies can pay a TPR, which are independent, accredited commercial entities, to “pre-approve” medical device applications. They will review the dossier in detail, often requesting more information from the manufacturer bfore issuing their preapproval letter; COFEPRIS will complete a final review and issue the registration certificate. Third party reviewers are local Mexican companies and are not associated with any globally recognized registrars/notified bodies.
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.
What is the “fast track” 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, as well as meet other route-specific requirements, such as having been inspected by the FDA and have their 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. Under this route a fair amount of technical information is still required; 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 and now takes up to one year to obtain approval. The fastest method at the moment is the TPR system mentioned above, which takes an average of four months.