{"id":3713,"date":"2024-09-03T20:36:22","date_gmt":"2024-09-03T20:36:22","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=3713"},"modified":"2025-06-24T23:43:35","modified_gmt":"2025-06-24T23:43:35","slug":"hygienic-products-as-medical-devices-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/hygienic-products-as-medical-devices-in-mexico\/","title":{"rendered":"Hygienic Products as Medical Devices in Mexico"},"content":{"rendered":"

Hygienic products, typically thought of as substances for personal cleanliness, hold a unique position in Mexico’s regulatory landscape. Classified as medical devices<\/strong>, these products fall under the scope of COFEPRIS<\/a>, requiring sanitary registration to be commercialized in the country. In this article, we briefly describe the characteristics and regulatory requirements surrounding these products.<\/p>\n

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Defining Hygienic Products in Mexico<\/strong><\/h3>\n

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Mexico’s General Law of Health<\/a> provides a specific definition for hygienic products based on their intended use. They are materials and substances applied to the skin or body cavities with pharmacological or preventive action. In essence, any hygienic product containing a pharmacological substance and formulated for a specific use or prevention must be considered a medical device.<\/p>\n

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Classification of Risk<\/strong><\/h3>\n

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The Supplement of Medical Devices<\/a>, outlines the risk classification for hygienic products. Products used externally (skin, nails, hair, lips, mouth, nose) and not absorbed by mucosal membranes generally fall into Class I. However, vaginal or genital lubricants are classified as Class II, indicating a higher risk profile.<\/p>\n

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Specific Requirements for Registration<\/strong><\/h3>\n

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Registering hygienic products as medical devices involves meeting specific requirements:<\/p>\n

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