Classification and Grouping for Orthopedic Implants
As mentioned in our Classification and Grouping Ultimate 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 […]
What do you need to transfer your sanitary registration in Mexico?
A rights transfer is a legal procedure where the Sanitary Registration Holder is changed. In this process the original owner of a Sanitary Registration transfers its rights to another company (the new Holder), as long as critical conditions previously authorized are not changed. The new Holder acquires the rights for manufacturing, importing, exporting, […]
How the regulation for Medical Devices in Mexico changed due to COVID-19
Introduction During the COVID-19 health contingency, various economic activities have been altered. The medical device industry is not an exception. Therefore, in this article we summarize how this sector has been affected in the latest months and what measures the health authorities in Mexico have taken. We will focus on specific medical devices that […]
Sanitary registration modifications in Mexico
If you have an approved medical device sanitary registration in Mexico, it is important to consider that any modification have a great significance in this authorization lifecycle. In this article, we explain in which cases is necessary to request a modification to COFEPRIS. This will help you to avoid problems during exportations or marketing […]
New Cofepris submission guide
Introduction Last 20 February 2020, COFEPRIS issued the Guide for Submissions with the aim of establishing clear rules in the submission process. This document was released by the Sanitary Authorization Comission (CAS) –a division of COFEPRIS that approves Sanitary Registrations, Import Permits and other official authorizations. In this article we highlight the main features […]
Medical Device Regulatory Overview (Mexico)
Considering Mexico as the second largest medical device market in Latin America, you may find it as a good alternative to expand your business. Nevertheless, there are a few considerations to register your products in the country. In this brief overview, we will describe what you need to register your medical device in Mexico and […]
Import permits for Medical Devices in Mexico
In accordance with Mexican laws, importing a medical device in Mexico requires a valid Import Permit, this document is issued by COFEPRIS. There are eight different types of Import Permits, the first point to consider is to know if the medical device to be imported has a sanitary registration in Mexico. If so, Case […]
What is a Third Party Reviewer for Medical Devices?
A third party reviewer (TPR) is a company authorized by COFEPRIS to review and issue an opinion regarding the compliance of a medical device to obtain the Sanitary Registration in Mexico. In other words, a TPR is an organization that meets all the legal requirements to help COFEPRIS by performing a previous review of […]
Good Manufacturing Practices Guide for Mexico
Last March the 6th, COFEPRIS updated its Good Manufacturing Practices (GMP) guide. This guide describes the criteria to evaluate the good manufacturing practices certificates or equivalent documents submitted when requesting, modifying or extending a medical device sanitary registration. In this review, we highlight the most important points included in this guideline. GMP’s […]
Equivalency Agreement summary
Every controlled medical devices intended to be sold in Mexico must undergo a previous authorization by the Mexican Ministry of Health before its commercialization. The aforementioned authorization is a document called Sanitary Registration, which COFEPRIS (the Mexican FDA) issues after evaluating a set of requirements. In addition, there are two ways to obtain the […]
