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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