Chile medical device registration resources

Competent authority

The Instituto de Salud Pública de Chile (ISP) is the competent authority for medical devices and IVDs ('elementos de uso médico'): it authorizes and supervises the control/certification of…

Core device regulation

Decreto Supremo N°825/1998 (Reglamento de Control de Productos y Elementos de Uso Médico), together with Article 111 of the Código Sanitario (DFL 725/1968), governs medical devices: they ma…

New 2026 decree extending mandatory registration

Decreto Exento N°25/2026 (promulgated Santiago, 6 March 2026; published in the Diario Oficial on 19 March 2026) incorporates 39 categories of medical devices and IVDs into the sanitary cont…

Medical device definition

D.S. N°825/1998 defines a medical device (dispositivo médico / artículo de uso médico) as any instrument, apparatus, application, material or article, including software, used alone or in c…

IVD definition

D.S. N°825/1998 defines in vitro medical devices (dispositivos médicos in vitro) as any medical use article consisting of a reagent, reagent product, calibrator, control material, equipment…

Risk classes I through IV for conformity-verification purposes (D.S. 825/1998).

Clase I, Clase II, Clase III, Clase IV

Categories requiring registro sanitario today

model: Mandatory sanitary registration (registro sanitario) with ISP currently applies to 10 DM/DMDIV types per the ISP ANDIM page (as of 2026 08): surgical latex gloves and medical examina…

DE 25/2026 products need registro sanitario

From the transition schedule dates of Decreto Exento N°25/2026, the listed devices/IVDs may only be manufactured in Chile, imported, marketed or distributed if they hold the corresponding v…

Foreign export/free-sale certificate accepted

For imported devices, D.S. N°825/1998 requires a certificate for export purposes issued in the country of origin, authorized by the corresponding state authority and duly legalized; the cur…

Alternative international standards accepted

Under Art. segundo of Decreto Exento N°25/2026, the applicant (titular) may demonstrate conformity with the internationally recognized essential principles of safety and performance using a…

Applicant: local manufacturer or authorized representative/titular

The registro sanitario may be requested by the legal manufacturer domiciled in Chile, or by an 'Authorized Representative or Titular': any natural or legal person established in Chile who h…

Company enrollment prerequisite

Before filing for device registration, the company must have completed: company enrollment (Inscripción de Empresa), warehouse authorization (Autorización de Bodega), and the request for th…

Warehouse sanitary authorization

To obtain the Customs Destination Certificate (CDA) in the GICONA system, the requesting company must have a warehouse with sanitary authorization granted either by the Seremi de Salud (reg…

Import customs control

Customs clearance (destinaciones aduaneras) of devices under this regime is performed with certificates from the respective Servicio de Salud, in accordance with Law N°18.164, and their use…

Common registration dossier documents

Registration dossier (ficha 9100003) requires, as applicable to the device type: (1) certificate of verification of conformity and reports from an authorized national body (except defibrill…

AED-specific dossier documents

For portable automated external defibrillators (Decreto Exento 42/2021), the dossier additionally requires: IEC 60601 1, IEC 60601 2 4 and IEC 60601 1 2 compliance certificates; evidence of…

Electronic filing platforms (SAFIS/GICONA)

submissionSurface: ANDIM page: electronic filing of the registro sanitario through the GICONA online system. The current filing sheet (9100003, v02 09/07/2025) directs the online form and p…

Registration code on label

The device registration is identified by an alphanumeric code granted by ISP, which must be incorporated legibly on the label (rotulado) of the DM/DMDIV.

Label/IFU language rules for HIV IVDs

For professional use HIV IVDs intended for trained users, a label in English with international symbology is accepted provided the insert (IFU) is in Spanish. The instructions for use must…

QMS and risk standards basis under DE 25/2026

For devices incorporated by Decreto Exento N°25/2026, ISP's verification of conformity is a documentary review per Título IV of D.S. N°825/1998 and the following technical norms: NCh ISO 16…

Manufacturer QMS certificate in dossier

The registration dossier must include the legal manufacturer's quality management system certificate for manufacturing — ISO 13485, ISO 9001 or another equivalent — consularized or apostill…

ISP NCh-norm documentary verification

Electrical safety

Product-specific IEC and sterility certificates

Product-specific

SUBTEL short-range radio certificate or QR marking

Wireless / radio

Registration dossier review (item 9100002)

CLP 487,880

Registration authorization (item 9100003)

CLP 165,628

ISP sanitary registration (medical devices) · ISP registration

60 working days

ISP sanitary registration (in vitro diagnostics) · ISP registration

60 working days

Registration validity 3 years, auto-renewed

The device registration authorization is valid for 3 years counted from notification (per Article 7 of the Código Sanitario), and is automatically and successively extended for equal period…

Significant change requires new registration

At the titular's request, ISP may modify the registro sanitario by reasoned resolution, provided the requested changes do not constitute a significant modification that could affect the dev…

Change notification duty under DE 25/2026

Any device that, after verification of conformity and obtaining the registro sanitario, undergoes modifications in design, manufacture, intended use, raw materials or components, performanc…

Distribution traceability records

Storage/distribution establishments must keep distribution records sufficient for traceability (recipient location/name/address, batch number, manufacture and expiry dates, quantity distrib…

Implantable-device traceability registry

Establishments must keep a traceability registry for all implantable devices considered high risk for the patient, specifically: cardiac implants and central circulatory system vascular imp…

Authorization for investigational use

Devices (elementos de uso médico) used in scientific research in humans require a special authorization for provisional use granted by ISP — required both for unregistered devices and for r…

Trial adverse-event notification duty

The authorization holder, sponsoring entity, principal investigator and the study center are responsible for notifying ISP and the corresponding Scientific Ethics Committee of adverse react…

Emergency provisional sale/use authorization

ISP's Director may authorize the sale or provisional use of devices governed by D.S. N°825/1998 without prior verification of conformity in situations of national emergency or where the pop…

Manufacturer investigation report within 6 months

On receiving an adverse event notification, the legal manufacturer, importer or authorized representative must investigate and answer ISP using form ANDID/008 (including root cause analysis…

Reportable events, forms and channel

Notifiable adverse events are those that harm the patient or user of the device (e.g., device malfunction when used as intended causing temporary harm). ISP's notification system uses four…

Vigilance notification deadlines

seriousEventsOrSentinel: As soon as possible and no later than 3 working days (días hábiles) from becoming aware · adverseEvents: As soon as possible and no later than 30 working days · inc…

FSCA notification and Spanish field-safety notice

Field safety corrective actions (FSCA) must be notified to ISP using form ANDID/012 sent to tecnovigilancia@ispch.cl; customers must be informed through a Field Safety Notice (FSN) in Spani…

Seizure of non-certified devices

Devices marketed or distributed by any title without the corresponding conformity verification certificate shall be seized (decomisados), without prejudice to other measures the health auth…

No source-verified answer is published for this dimension yet.

Written claims within 15 working days

Persons whose devices are rejected in the conformity verification by an authorized entity may claim in writing to ISP within 15 working days from communication of the non conformity (Art. 6…

Deficiency handling and communications

Once evaluation starts, if problems are detected in the submitted documents, the applicant receives an email notification with the details of the observations to be cured; the resolution is…