Agency
All medical devices are regulated by the ISP (Instituto de Salud Pública or Public Health Institute).
Classification of Medical Device
International Classification |
Examples |
Risk Level |
Class I |
Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale |
Low |
Class II |
Pregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask |
Low - Moderate |
Class III |
Blood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lens |
High - Moderate |
Class IV |
HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker |
High |