{"id":313,"date":"2020-01-14T21:25:07","date_gmt":"2020-01-14T21:25:07","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?page_id=313"},"modified":"2025-05-09T15:06:56","modified_gmt":"2025-05-09T15:06:56","slug":"classification-and-grouping-ultimate-guide","status":"publish","type":"page","link":"https:\/\/veraqueconsulting.com\/mx\/classification-and-grouping-ultimate-guide\/","title":{"rendered":"Classification and Grouping Ultimate Guide"},"content":{"rendered":"\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/header>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Classification and Grouping Ultimate Guide.\n<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\tAs in any other country, the ministry of health in Mexico classifies medical devices in different groups based on their level of risk. In addition, the Mexican authorities have established grouping criteria that allow the allocation of similar products in the same sanitary registration.\n\nIn this guide we present a thorough explanation of the classification and grouping criteria. You can find this information in the Supplement of Medical Devices1<\/sup>, published by the Mexican Pharmacopeia (FEUM)2<\/sup>.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t
\n\t\t\t
<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Introduction<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

The criteria for grouping and classification have for a long time been a complex topic in Mexico. For many years the ministry of health released on its webpage two guides to understand the classifications and groupings for medical devices. The main problem is that those guides were a mere reference and the authority maintained a subjective decision in reference to all grouping. This was in part due to the vagueness of the guides\u2019 descriptions and sometimes with an argument that the classification and grouping criteria were only that: \u201cguides\u201d.<\/p>

To tackle such disputes, the Mexican Pharmacopeia (FEUM) introduced updated guides in the Supplement of Medical Devices as an Appendix. In its latest version we can find more details to make a better assessment when you need to classify and group your products. This is the first step we recommend to do. Otherwise, you may end up with an incorrect classification which means incurring extra fees and submitting more documents if the classification is higher. In addition, if the groups you choose to include in one registration are not acceptable, the ministry of health will simply reject your grouping and request that you start the process from scratch. Both scenarios represent a waste of time and money.<\/p>

To close this section, it is worth mentioning that these are still just guides, but at least as they are included in the supplement of medical devices, do provide a reference for the ministry of health. Even though you will find some discrepancies in different legal sources in the law, the supplement is your best reference. You can check our ultimate guide for regulatory affairs in Mexico for more details.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Is my product a medical device?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\tThe first question you have to ask before initiating a classification is if your product is considered a medical device in Mexico. Fortunately, in most cases, this is not a complicated task to solve. Specifically, the ministry of health has released an agreement that lists all the low risk medical devices and those products that are not considered medical devices3<\/sup>. This document is official and allows to easily identify if your product is not a medical device or a class I low risk. Then if your product is included in the non-medical device list, you do not have to do anything else, at least in regulatory terms. Nevertheless, we strongly recommend following the advice provided in our ultimate guide for regulatory affairs in Mexico \u2013 we offer a few suggestions to eliminate potential risks.\n\nTo close this section, we frequently receive questions about accessories. This is a hot topic when accessories are included with a medical device raising questions like:\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t