Alternatives to register in Mexico a Medical Device with no Certificate of Free Sales.
Requirements to obtain a Medical Device Sanitary Registration in Mexico are well established. However, such requirements imply that the Ministry of Health from the country of origin approves the device. In this article, we explore some cases when the product is not sold or approved in its country of origin and alternatives to register it […]
Duplicate Medical Device Registrations in Mexico
Background Obtaining a Sanitary Registration for a medical device in Mexico is a complex process that may take from months up to years. Thus, once obtained, it is very important to maintain those authorizations valid. Specifically, being aware of when to renew them, when to request an amendment through an administrative or technical modification […]
The Medical Device Manufacturer definition (The Mexico case)
In general terms, a manufacturer is defined as a company who makes products. In some industries, such as in the medical device one, the supply chains tend to be complex, considering that more than one company can be involved in the process. Such elaborated network raises questions of who is the main manufacturer and how […]
Japan Equivalency Agreement for Medical Devices in Mexico
In previous articles and guidelines, we have explained the registration process for medical devices in Mexico though the so called ordinary process and equivalency agreements, also known as fast-track processes. This time, we will go deeper into Japan equivalency agreement. To clearly understand the requirements for the Japan equivalency agreement, first we need to […]
NOM 064 – Official Mexican Standard for in vitro diagnostics
Unlike other countries, in vitro diagnostics IVDs in Mexico are considered as medical devices and thus subject to general regulations and special rules for its classification and grouping. However, there is a specific standard that IVDs must accomplish in addition to other regulations, and we will explain it briefly in this text. Background […]
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 […]
