Process to Apostille Legal Documents
Introduction As we have detailed in our previous article, Apostille and Legalization are common procedures to authenticate legal documents in the Medical Device Industry. In this way, local sanitary authorities can validate them. In the following article, we will explain the general process to authenticate documents through Apostilled since this is the best […]
Advertising Regulation for Medical devices in Mexico
In Mexico, activities related with medical devices such as advertising, manufacturing, importation, exportation, storage, disposal and others are strictly regulated by COFEPRIS. In this article, we will explain the characteristics of medical device advertising and general requirements for notifications and permits. What is regulated? The publicity of medical devices are regulated by the […]
NOM241 for Medical Device Good Manufacturing Practices in Mexico
Last December 20th 2021, the Ministry of Health in Mexico released the official update of the Good Manufacturing Practice (GMP) Norm for Medical Devices (NOM241-SSA1-2021). This new norm will substitute its previous version (NOM241-SSA1-2012), which will become obsolete by June 20th 2023. This article will be focused on describing the main changes compared to […]
Medical Device Supplement from the Mexican Pharmacopoeia
Introduction The Mexican Pharmacopoeia (FEUM) is an independent organization dedicated to advice the Mexican Ministry of Health. 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 […]
Classification and Grouping for Surgical Instruments in Mexico
As mentioned in our Classification and Grouping Guide, there are a series of rules to consider when classifying and grouping medical devices. The above-mentioned rules are fully explained in Appendix II – Supplement of medical devices of the Mexican Pharmacopeia (FEUM). In this article we will focus on explaining strategies to classify and group […]
Classification and grouping of facemasks in Mexico
Facemasks consist in a protective covering for the mouth and nose. They are usually made from non-woven fabric and designed to avoid spreading infectious microorganisms, such as viruses and bacteria. In regulatory terms, there are different types of facemasks that also differ in their classification. In Mexico, we can define three classifications according to […]
Regulatory requirements for medical device clinical trials in Mexico
A clinical trial for medical devices can be defined as a systematic research or study in humans, conducted to evaluate the safety or performance of the product. Mexico can be an interesting country to perform such clinical trials, not only because of the lower costs and reduced timelines compared with other nations, but the great […]
COFEPRIS keeps its digitalization process through DIGIPRis
As reported last September 2020, COFEPRIS has kept its digitalization strategy with the solid conviction to optimize the approval process for both medical devices and pharmaceutics. In this stage, COFEPRIS announced the platform DIGIPRiS. In this article, we will describe more details about how this digital alternative works and for which regulatory processes is applicable. […]
Classification and regulation of sanitizers in Mexico
Sanitizers in regulatory terms are complex products. In some countries, they are classified as cleaning products, cosmetics or biocides. In addition, their sanitary authorization is not required in all countries. This is the case for Mexico, in which sanitizers can be classified as medical devices or require to comply with Mexican Norms. In this article […]
Classification and Grouping for Dialysis machines and accessories in Mexico
As mentioned in our Classification and Grouping Guide, there are a series of rules to consider when classifying and grouping medical devices. The above-mentioned rules are fully explained in Appendix II – Supplement of medical devices of the Mexican Pharmacopeia (FEUM). In this article we will focus on explaining strategies to classify and group […]
