Last March 19th 2021, COFEPRIS published a guideline with rules and requirements related to COVID-19 (SARS-CoV2 virus) supplies in Mexico. Even though the purpose of this guide is to provide formality on regulatory processes and clarify common questions for the industry, we do still find certain gaps for which the users should be cautious.
Therefore, in this article we would like to present a brief summary, pointing out those processes that are still ambiguous. It is worth mentioning that we will focus on those parts of the guideline related to medical devices.
The first point to consider is that the authorizations referred on this guide, either GMP (Good Manufacturing Practices) certifications or product approvals, hold a temporary condition. As a reference, due to the COVID-19 emergency, COFEPRIS provides alternatives to expedite the responses through temporal authorizations. This means, that once you submit your paperwork, COFEPRIS will focus on specific documents (referred in the guideline), instead of reviewing all the technical data –which is the standard process. Within 10 working days, COFEPRIS should release a temporal authorization, while they keep reviewing the rest of the technical data. During a reported 24 month timeline, COFEPRIS should provide a standard sanitary authorization to substitute the temporal one.
We hereby present some of the requirements that a Medical Device company should submit through their designated MRH (Mexican Registration Holder), when looking for this temporal approval:
- Operating notification, of the commercial partner in Mexico.
- GMP certificate, either ISO 13485:2016 or CE mark certificates.
- Letters of representation, issued by the manufacturer, for both the MRH and the distributor.
- Instructions for use or user manual.
- Test reports issued by laboratories previously accepted and recognized by COFEPRIS.
Regarding the last requirement on this list, the guideline is not specifying which are the recognized laboratories and for which products. They are not either describing what type of reports must be presented.
Based on our experience, the following institutes has been recognized by COFEPRIS for IVDs and ventilators:
- InDRE, TecSalud and Salvador Zubirán Institute, for IVDs including PCR and screening tests for antigens or antibodies.
- CENAPRECE, for invasive and non-invasive ventilators.
Nevertheless, products like oximeters, thermometers, masks and other supplies do not have any sort of specification. The good point is that COFEPRIS published on its webpage the laboratories they recognize. You can use it as a reference to evaluate with them if a specific test is required.
Even though the expedited process for Covid-19 related products was formally reported. There are still open questions about the local tests to be performed. The 10 working days to deliver a temporal authorization is a great relief for the market demand, but you should be cautious about the time it takes to perform local tests. This could be critical in your projected timelines.
If you have any question about how to register your Covid-19 related supplies in Mexico, please contact us at firstname.lastname@example.org