Mexico
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
Intraocular lenses (IOLs) are implantable devices used to replace the eye’s natural crystalline lens during cataract surgery or refractive procedures. Their design, materials, and optical
Introduction Importing medical devices into Mexico involves more than shipping logistics, it requires strict compliance with local regulations enforced by COFEPRIS and Mexican customs authorities. For foreign manufacturers,
Combination products, those integrating a medicinal substance with a medical device, are increasingly relevant in modern healthcare. These products enable targeted delivery, improve patient adherence, and optimize therapeutic outcomes.
