Mexico
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.
Pill organizers are widely used to assist patients in managing medication schedules. These products help improve adherence and reduce dosing errors, particularly in chronic disease management. This
Introduction Technovigilance in Mexico is a critical post-market surveillance activity that ensures medical devices remain safe and effective throughout their lifecycle. For foreign manufacturers entering the Mexican market, understanding
If your medical device has successfully obtained a sanitary registration from COFEPRIS, you have cleared a major regulatory hurdle in Mexico. However, this authorization marks the
