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 |