Chile Medical Device Regulations

Regulatory Agency

The ANDID (National Agency for Medical Devices, Innovation, and Development) agency regulates and guarantees the safety and performance of medical devices, including in vitro diagnostic medical devices.

Medical Device Definition

Any instrument, apparatus, application, material or article, including software, used alone or in combination and defined by the manufacturer for direct use in human beings, provided that its primary intended action in the human body is not achieved by pharmacological, immunological or metabolic, although such means may concur to their function; for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability; research or replacement or modification of anatomy or a physiological process, or regulation of conception.

Medical Device Classification System

Classification	Risk Level	Examples
Class I	Low Risk	Bandage, Surgical camera; Electric operating table, Patient scale
Class II	Low - Moderate R isk	Pregnancy self-testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask
Class III	High - Moderate Risk	Blood glucose self-testing, ECG, X-ray Unit, Syringe, Condom, Contact lens
Class IV	High Risk	HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker

Regulatory Approval Process

Classification	Approval procedure
Class I	Appoint a local authorized representative in Chile. Access GICONA system and click on "request registration". Fill in the form, attach the documents and submit the application for registration. Select the payment method: Through the website of the Treasury of the Republic. Deferred payment at the ISP. A purchase order will be generated. Click "Save order" and pay through TGR or print the payment form, as appropriate. In approximately 60 days, once the procedure has been evaluated and resolved, a notification will be sent via email indicating the application is resolved.
Class II
Class III
Class IV
Note: Medical Devices and In Vitro Diagnostics are subjected to the same procedure (Except in vitro Diagnostic Medical Devices for the detection of HIV).

Additional Information

Approval timeline

Class I:- 2 to 3 months Class II, III, IV:- 6 to 10 months

License validity period

Does not expire.

Fees

Description	Fees [CLP]
Medical Device evidence file revision	$434.151
Registration of Medical Devices under Sanitary Control	$147.388
Registration of Manufacturer, Importer, Distributor and/or Representative of Medical Devices	$29.816
Listing of Manufacturers and/or Exporting Companies, Importers and /or Distributors; and the list of products to be marketed.	$277.582
Registration of In Vitro Diagnostic Devices with ISP Verification	$5.140.395
Registration of In Vitro Diagnostic	$433.655
Establishment License. Authorization of Establishment, Operation or Modification of Wharehouses for Medical Devices under sanitary control.	$811.184

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