Chile Medical Device Regulations

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
Premarket Approval Process
In general, it is not required to register medical devices, however, it is recommended that they have a voluntary certification.
Appoint an authorized representative (AR) in Chile.
Provide information including name of AR and verification of conformity.
ISP will conduct an audit to ensure information provided is valid.
If approved, ISP will issue certification.
Additional Information
Validity Valid until any of the relevant certificates expire
Postmarket Surveillance Vigilance controls in place
Timeline 2-3 months
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