Chile Medical Device Regulations via ANDID

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

Medical devices or articles for medical use: Any instrument, apparatus, application, material, or item, including software, used alone or in combination and defined by the manufacturer to be used directly on human beings, provided its main intended action is on the human body. It is not achieved by pharmacological, immunological, or metabolic means, although such means may contribute to its function; for diagnosis, prevention, monitoring, treatment, or alleviation of disease, injury, or disability; research or replacement or modification of the anatomy or a physiological process, or regulation of conception.

Active Medical Device: any device whose operation depends on electrical energy or any source of distinct energy generated directly by the human body or by gravity and which acts through conversion of energy. Active medical devices are not considered to be products intended to transmit energy, substances or other elements of an active medical device to the patient without any significant modification.

Therapeutic Active Medical Device: any medical device used alone or in combination with other medical devices intended to support, modify, replace or restore functions or biological structures in the context of treatment or relief of an illness, injury or disability.

Active Medical Device for Diagnosis: any active medical device used alone or in combination with other medical devices intended to provide information for the detection, diagnosis, control or treatment of physiological states, health states, illnesses or congenital malformations.

Medical Device Classification System

Classification	Risk Level	Examples
Class I	Low Risk	Bandage, Surgical camera; Electric operating table, Patient scale
Class II	Low - Moderate Risk	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 Class II Class III Class IV	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.
Note: Medical Devices and In Vitro Diagnostics are subjected to the same procedure (Except in vitro Diagnostic Medical Devices for the detection of HIV).

Classification

Approval procedure

Class I

Class II

Class III

Class IV

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.

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: 60-75 days Class II, III, IV: 6 to 10 months

License validity period

Does not expire.

Fees

Application	Fee [CLP]
Sanitary registry of medical devices	$182,232.00
Sanitary registry of in vitro diagnostic medical devices	$536,789.00
Authorization of medical device storage warehouses	$1,002,956.00
Registration of companies with the list of medical devices	$343,205.00
Verification of conformity	$3,223,485.00
Request for background review accompanying medical device	$536,789.00
Admission of request for control of diagnostic kit	$536,789.00
Sanitary registration of in vitro diagnostic medical devices with verification in ISP	$6,355,636.00

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