{"id":1984,"date":"2021-11-23T15:38:47","date_gmt":"2021-11-23T15:38:47","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=1984"},"modified":"2026-02-24T17:49:41","modified_gmt":"2026-02-24T17:49:41","slug":"classification-and-grouping-for-surgical-instruments-in-mexico","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/classification-and-grouping-for-surgical-instruments-in-mexico\/","title":{"rendered":"Classification and Grouping for Surgical Instruments in Mexico"},"content":{"rendered":"

Managing the sanitary registration for surgical instrument catalogs in Mexico requires a specialized approach to grouping, especially when dealing with hundreds of specialized models and varying materials.\u00a0<\/span>\u00a0<\/span><\/p>\n

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While these devices must align with\u00a0<\/span>Mexico\u2019s general classification\u00a0and grouping\u00a0criteria<\/span><\/b><\/a>, the high volume of SKUs and diverse manufacturing origins often present unique hurdles during the COFEPRIS submission process. In this article, we move beyond the general principles to explain how to strategically group surgical tools to optimize regulatory compliance.<\/span>\u00a0<\/span><\/p>\n

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General characteristics of Surgical Instruments<\/strong><\/h3>\n

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Talking about surgical instruments can embrace a wide range of specialties. Nevertheless, in this article we will focus on those common supplies used in medical practice during surgery (e.g. forceps, scalpels, clamps, retractors, and scissors).<\/p>\n

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Manufacturers of these instruments generally manage catalogues with hundreds of models that vary in size and intended use. We have seen for years, that a normal practice in the manufacturing cycle is to receive an unprocessed instrument (or the raw material) from one country and process it in another. This particular case, when the instruments are processed in different sites, is a key point to identify the real manufacturer \u2013a relevant entity in regulatory terms.<\/p>\n

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Another key element about these type of instruments is the material. They are usually made of medical grade stainless steel, although the materials can also be as variable as the purpose and quality of the instruments. As mentioned, the manufacturer catalogue is generally extensive and the materials are not necessarily the same in such cases.<\/p>\n

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Every point described so far has regulatory implications that we will explain in the following section.<\/p>\n

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Classification Criteria for Surgical Instruments<\/strong><\/h3>\n

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Surgical instruments by their nature are classified as Class I medical devices in Mexico. This is applicable only for those instruments sold non-sterilized. For sterilized instruments from origin, the Ministry of Health in Mexico considers them as class II medical devices.<\/p>\n

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Registration Grouping Rules for Surgical Tools<\/strong><\/h3>\n

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The classification for Surgical Instruments is pretty straightforward. Yet, it is still necessary to consider a few points regarding the grouping criteria. Specifically, surgical instruments can be grouped in the same Sanitary registration if they:<\/p>\n

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