{"id":2350,"date":"2022-01-19T16:47:52","date_gmt":"2022-01-19T16:47:52","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=2350"},"modified":"2025-09-26T22:28:22","modified_gmt":"2025-09-26T22:28:22","slug":"advertising-regulation-for-medical-devices-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/advertising-regulation-for-medical-devices-in-mexico\/","title":{"rendered":"Advertising Regulation for Medical devices in Mexico"},"content":{"rendered":"

In Mexico, activities related with medical devices such as advertising<\/strong>, manufacturing<\/a>, importation<\/a>, exportation, storage, disposal and others are strictly regulated by COFEPRIS<\/a>. In this article, we will explain the characteristics of medical device advertising and general requirements for notifications and permits.<\/p>\n

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What is regulated?<\/strong><\/h2>\n

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The publicity of medical devices are regulated by the General Law of Health, the Health Supplies Regulation<\/a> and the Regulation from the General Law of Health in Advertising Affairs<\/a>. The aim of the above-mentioned regulations is to control the publicity regarding the existence, quality, and characteristics of any medical device, including the promotion, marketing and use.<\/p>\n

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Types of advertising<\/strong><\/h2>\n

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There are two advertising classifications for medical devices:<\/p>\n

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  1. For Healthcare professionals only:<\/strong> This kind of ads can only be targeted to Healthcare professionals including physicians, technicians, nurses and personal related exclusively within the healthcare sector. In this case, the publicity includes technical information regarding a medical device in a form of brochures, catalogues, posters, videos, webpages, and other specialized media.<\/li>\n
  2. General public:<\/strong> For this second classification, the advertisements can be focused on the general population. This kind of publicity can be in a format of leaflets, signs, posters, magazine ads, TV, radio commercials, internet multimedia and other mainstream media.<\/li>\n<\/ol>\n

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    Advertising notice vs permit<\/strong><\/h2>\n

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    There are two ways to legally launch publicity for medical devices in Mexico:<\/p>\n

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    1. Advertising notice:<\/strong> This type of procedure<\/a> is necessary when the ads are intended for Healthcare professionals. The request must be submitted to COFEPRIS with the code COFEPRIS-02-001-A<\/strong> at least 15 days before<\/em> releasing the ad for each product and distribution channel. The submission number must be included in the final advertising.<\/li>\n
    2. Advertising permit:<\/strong> This authorization<\/a> is needed in ads for the general public. The request must be approved by COFEPRIS before launching the ad campaign. This permit must be requested under the code COFEPRIS-02-001-B for each product and distribution channel. The authorization number must be later included in the final version of the advertisement.<\/li>\n<\/ol>\n

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      It is worth mentioning, that one of the key points to consider between a permit and a notice, is that the advertising notice does not require to be approved by COFEPRIS<\/strong>. Nevertheless, the authority is able to eventually inquire about the advertising notice.<\/p>\n

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      Requirements<\/strong><\/h2>\n

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      There are some common requirements to submit an advertising notice<\/strong> or requesting an advertising permit<\/strong>:<\/p>\n

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