The Mexican Regulatory Authority has recently decided that some of the Medical Devices classified so far as low risk will soon be deregulated. These changes concern 2,242 products, including tools for the removal of dental prostheses, dental floss, dental implants, ECG simulators, arrhythmia simulators, thermometers for laboratory use or for the calibration of instruments, systems for radiotherapy simulation, electrophoresis systems as well as dental spectrophotometers.
Another recent document introduces additional changes to the definitions of Medical Devices, in-vitro diagnostic Medical Devices, as well as their classification rules. Definitions for “Medical Equipment” and “Surgical and Care Consumables” have also been added. Moreover, the expression “a potentially dangerous way” has been clarified in relation to the technology involved and the device intended use.
For more information: http://www.cofepris.gob.mx/AS/Documents/RegistroSanitarioMedicamentos/no_registran.pdf