Classification of Software as a Medical Device in Mexico
As previously discussed in our article for Software as a Medical Device (SaMD), a significant development has occurred in the Mexican regulatory framework. The introduction of the first official approach to regulating SaMD marks a crucial step in the right direction, aiming to establish a faster and more comprehensive regulatory environment. However, the rapid […]
Authorization for the Acquisition and Transfer of Ionized Radiation Sources in Mexico
In Mexico, when registering medical devices related to Ionized Radiation Sources, there is a special subset of documents to be presented. The Authorization for the Acquisition and Transfer of Ionized Radiation Sources is one of these requirements. In this article, we provide a brief overview of this document within the context of the Mexican […]
Certificate to Foreign Government for Device Not Exported from the United States
As mentioned in our article about the Equivalency Agreement and our Ultimate Guide for Regulatory Affairs in Mexico, one of the choices you have to register a Medical Device for its sale and distribution in Mexico is the Equivalency Agreement route. In this regulatory pathway, one of the key documents for the FDA Equivalency route […]
Electrical Testing Standards for medical electrical equipment and its use in Mexico
In a previous article, we have reviewed the regulations for medical electrical equipment (MEE) in Mexico and mentioned the cases when a medical electrical equipment needs to meet local standards. In this article we will review the applicability of a key series of international technical standards for medical electrical equipment, the IEC 60601. […]
Classification and Grouping for Urology Medical Devices in Mexico
When registering Medical Devices in Mexico, the classification and grouping strategy is a key activity for optimizing the number of registrations (based on 23 rules). You can find some examples of the classification and grouping criteria in our previous articles for: Orthopedic Implants Ultrasound Systems Medical Imaging In vitro Diagnostics Surgical instruments Though, […]
Classification and Grouping for Dental Resins in Mexico
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 group specific medical […]
Changes on the Renewal Process for Medical Device Sanitary Registrations in Mexico
As a means to make regulatory processes more accessible and efficient to everyone in the medical device sector in Mexico, COFEPRIS started an upgrading strategy to turn to the digital approach when trying to submit information pertaining regulatory affairs. Thanks to this digitalization process, many of the old regulatory paths regarding the acquisition and upkeep […]
Low-Risk Medical Devices Requirements for Mexico
Obtaining the Sanitary Registration for a product in Mexico requires to consider different regulatory pathways. In knowledge of this circumstances, COFEPRIS made a distinction between products already widely recognized and sold in the market, giving that selection of products the title of Class I Low-Risk, as to reduce the regulatory hurdles in order to obtain […]
Explanatory letters for COFEPRIS
COFEPRIS provides a list of diverse requirements for Medical Devices that must be completed to obtain a sanitary registration in Mexico. Nevertheless, it is often hard for foreign manufacturers to fully comply with all of them. Some of the most common cases are: Documentation not elaborated by the manufacturer COFEPRIS requirements are specific for […]
Label and registration designs
There are specific requirements for obtaining sanitary registrations of Medical Devices in Mexico. Those requirements can be found in the COFEPRIS website, in the National Catalog of Regulations, Procedures and Services and also in our checklist website. In a previous article, we have explained the generals of labeling requirements for medical devices in Mexico, […]
