Retroactive renewals for Medical Devices in Mexico
In recent months, COFEPRIS has been experiencing a series of changes with the aim of attending overdue requests. In this article, we will focus on three fundamental events that are already being executed leading to a quicker renewal process for sanitary registrations: In May 2021, the Ministry of Health in Mexico updated the Health […]
Applicable standards for Medical Devices
Medical devices are a broad group of products with different characteristics. Thus, many standards have been developed to establish general and particular specifications for them. In this text, we cover the most relevant international standards that can be found in the medical device industry that are useful for regulatory purposes. ISO 13485 Medical devices […]
Combination products and regulatory approach in Mexico
In general terms, combination products consist in a pharmaceutical product including chemical synthesis molecules, biologic or biotechnological API’s, that are contained in a medical device. Such products are already being regulated in the USA and EU. In Mexico, it can be confusing registering a product combining medicines and medical devices. In this article we will […]
The use of tariff codes in Mexico for medical devices
In general terms, tariff codes are a series of numbers to identify products for international trade purposes. These codes are standardized worldwide by the Harmonized System (HS) established by the World Trade Organization (WTO). Although there might be exceptions, the tariff code is the reference to import goods in different countries. The main use […]
Classification and grouping for gloves
In our Classification and Grouping Ultimate Guide, we have explained how to classify and group medical devices according to the 23 rules detailed in the Appendix II of the Supplement of medical devices of the Mexican Pharmacopeia (FEUM). In addition, we have also explained how to make use of those rules to classify and […]
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 April the 4th 2025, the Ministry of Health in Mexico released the official update of the Good Manufacturing Practice (GMP) Norm for Medical Devices (NOM241-SSA1-2025). This new norm will substitute its previous version (NOM241-SSA1-2021), which will become obsolete by November 30th 2025. This article will be focused on describing the main changes compared […]
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
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. While these devices must align with Mexico’s general classification and grouping criteria, the high volume of SKUs and diverse manufacturing origins often present unique hurdles during the COFEPRIS submission process. […]