{"id":1715,"date":"2021-03-25T16:37:16","date_gmt":"2021-03-25T16:37:16","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=1715"},"modified":"2025-08-22T19:21:13","modified_gmt":"2025-08-22T19:21:13","slug":"new-guideline-for-covid-19-related-supplies-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/new-guideline-for-covid-19-related-supplies-in-mexico\/","title":{"rendered":"New guideline for Covid-19 related supplies in Mexico."},"content":{"rendered":"

Last March 19th<\/sup> 2021, COFEPRIS<\/a> published a guideline<\/a> 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.<\/p>\n

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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.<\/p>\n

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Guideline summary<\/h3>\n

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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 \u2013which 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.<\/p>\n

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We hereby present some of the requirements that a Medical Device company should submit through their designated MRH<\/a> (Mexican Registration Holder), when looking for this temporal approval:<\/p>\n

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