Mexico
The authentication of foreign-issued documents is an important time-consuming step when preparing a medical device regulatory submission in Mexico. Documents issued by foreign health authorities,
When preparing a medical device sanitary registration dossier in Mexico, one of the mandatory documents requested by COFEPRIS is the label design. Although the
Software has become a fundamental component of modern healthcare. From artificial intelligence applications that support diagnosis to embedded software controlling pacemakers and infusion pumps, software now plays
Software as a Medical Device (SaMD) has become one of the most dynamic areas of medical device regulation. For manufacturers, one of the first questions
Since 2025, Mexico’s regulatory framework for medical devices has been reshaped by a series of simplification agreements that directly affect how sanitary registrations are managed.
Ophthalmic laser systems, including excimer and femtosecond platforms, are widely used in refractive and cataract surgery. Their precision, programmable energy delivery, and integration with imaging
