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 ClassificationExamplesRisk Level
Class ICholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scaleLow
Class IIPregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical MaskLow - Moderate
Class IIIBlood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lensHigh - Moderate
Class IVHIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, PacemakerHigh
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
ValidityValid until any of the relevant certificates expire
Postmarket Surveillance Vigilance controls in place
Timeline2-3 months
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