Mexico
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
Mexico
Mexico
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
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,
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
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
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 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.