{"id":1993,"date":"2021-12-22T19:01:32","date_gmt":"2021-12-22T19:01:32","guid":{"rendered":"https:\/\/veraqueconsulting.com\/mx\/?p=1993"},"modified":"2025-05-17T00:38:37","modified_gmt":"2025-05-17T00:38:37","slug":"medical-device-supplement-from-the-mexican-pharmacopoeia","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/mx\/medical-device-supplement-from-the-mexican-pharmacopoeia\/","title":{"rendered":"Medical Device Supplement from the Mexican Pharmacopoeia"},"content":{"rendered":"

Introduction<\/strong><\/h2>\n

 <\/p>\n

The Mexican Pharmacopoeia (FEUM<\/a>) is an independent organization dedicated to advice the Mexican Ministry of Health<\/a>. It is also in charge to elaborate quality\/reference standards and technical documents for the regulation of medicines, medical devices, and other products. Among these documents, the Supplement of Medical Devices is a useful resource for manufacturers and distributors in Mexico. In this article, we describe the main features of it.<\/p>\n

\u00a0<\/strong><\/h3>\n

Supplement of Medical Devices <\/strong><\/h2>\n

 <\/p>\n

The supplement is considered an official document, which establishes the medical devices specifications to be accomplished to assure their quality, safety and performance. It is also a guideline of the analytical methods to be performed during the validation process. An interesting fact is that Mexico is the only country where its National Pharmacopeia released a document related to Medical Devices since 2006 (when the first edition was published). It is worth mentioning that this document is aligned with the harmonized regulatory system WHO model.<\/p>\n

 <\/p>\n

The latest edition is presented in the form of a physical book, with updates either in printed or digital version. On the other hand, as a requirement of the Mexican Standard NOM-241<\/a>, all medical device manufacturers, distributors or sanitary registration holders in Mexico must possess an original copy of the latest version of this document, which is copyrighted.<\/strong><\/p>\n

 <\/p>\n

Contents<\/strong><\/h2>\n

\u00a0<\/strong><\/p>\n

Given the large amount of information that can be found in the Supplement, this document is organized in the following sections:<\/p>\n

 <\/p>\n