Pure Global AI
ISP/ANDIM · structured requirements

🇨🇱 Chile medical device regulatory data

Explore the medical device requirements currently available for Chile, organized by topic and linked to official sources.

49 facts23 dimensions12 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

Compare countries

Deceptive publication or propaganda on preventive or curative medicine prohibited

advertising.deceptive-sanitary-publicity-prohibited
Fact-level verified

Any form of publication or propaganda concerning hygiene, preventive or curative medicine and similar branches which, in the judgement of the health service, tends to deceive the public or to harm collective or individual health is prohibited.

Conditions
  • The prohibition is assessed by the health authority ('a juicio del Servicio Nacional de Salud'); it is a substantive deception standard, not a pre-clearance requirement, and no advertising approval is issued for it.
  • The article does not use the term 'dispositivo médico'. It is the Código Sanitario's general sanitary-publicity prohibition and is cross-referenced by art. 100 for pharmaceutical advertising; its reach to a given device claim follows from the 'higiene, medicina preventiva o curativa y ramas semejantes' wording, not from an express device reference.
  • The article still names the Servicio Nacional de Salud, a body that no longer exists; I did not verify which authority now exercises this particular power for devices.

Effective from 1968-01-31

Source is Spanish. Código Sanitario, Libro I, Título V ('De la divulgación y educación sanitaria'). The article carries no amendment marker in the consolidated text in force from 18.11.2025, so it is quoted as original text; effectiveFrom is the Diario Oficial publication date of D.F.L. N° 725 (31.01.1968).

Goods may not be announced as of medical utility without prior authorisation

advertising.medical-utility-claim-requires-authorisation
Fact-level verified

No product may be advertised as 'medicinal, nutritive or of medical utility' other than those that have been authorised or recognised as such by the health service. The provision states the rule by claim category and does not enumerate product types.

Conditions
  • The rule is expressed as a prohibition on the claim, and the authorisation it refers to is the health service's recognition of the product, not a separate advertising clearance.
  • The article names 'productos medicinales, nutritivos o de utilidad médica'; the Código Sanitario's own device title (Título IV, art. 111) uses different vocabulary ('instrumentos, aparatos, dispositivos y otros artículos o elementos') and contains no advertising rule, so the reach of this provision to a device presented as being of medical utility is not express.
  • The article still names the Servicio Nacional de Salud; I did not verify which authority now exercises this power over devices.

Effective from 1968-01-31

Source is Spanish. Código Sanitario, Libro I, Título V, art. 54, second sentence. The first sentence of art. 54 defines sanitary deception for the offer of services by persons not legally authorised to practise medicine; the quoted second sentence is the one that speaks to advertised product claims. No amendment marker appears on the article in the consolidated text in force from 18.11.2025.

Incentive prohibition names devices and may be extended to elements of medical use

advertising.prescriber-incentive-prohibition-device-extension
Fact-level verified

Advertising-purpose donation of pharmaceutical products is prohibited, as are incentives of any kind that induce preference for the use, prescription, dispensing, sale or administration of one or more pharmaceutical products to any person; the Ministry of Health may by reasoned supreme decree include certain 'elementos de uso médico' (elements of medical use, i.e. medical devices) within this prohibition; and 'incentive' is defined to cover any payment, gift, service or economic benefit given by anyone with an interest in preference being given to the use of one or more products or devices.

Conditions
  • The prohibition itself is stated for pharmaceutical products. Its extension to elements of medical use is an enabling power of the Ministry of Health, exercisable by reasoned supreme decree; as at 2026-09-16 I found no such decree, so the extension is not asserted as being in force.
  • Devices are named in two places: the enabling clause ('algunos elementos de uso médico') and the statutory definition of 'incentive' ('...el uso de uno o más productos o dispositivos').
  • The restriction targets promotion directed at generating preference (including towards prescribers); it is the only provision in the Código Sanitario I found that names medical devices in a promotion context.

Source is Spanish. Código Sanitario, Libro IV, art. 100, fourth and fifth paragraphs. The Ley Chile consolidated text places amendment markers inside these paragraphs: the fourth paragraph was incorporated by Ley N° 20.850, Art. 34 N° 1 a), D.O. 06.06.2015, and amended by Ley N° 20.895, Art. 1 N° 1, D.O. 26.01.2016. I did not verify the entry into force of the amending act, so no effectiveFrom is asserted; the quotation is the consolidated text as published on Ley Chile. The excerpt is a single contiguous run of that consolidated text and therefore reproduces the publisher's own markers exactly, including the awkward points where they fall inside the article's wording: the marker for Ley N° 20.895 interrupts the word 'persona' ('a cualquier per' + marker + 'so' + the 'NOTA' anchor + 'na.'). Remove the two markers and the anchor and the sentence reads '...a cualquier persona. Con todo, ...'; nothing else differs.

Devices displayed at trade fairs may not be presented as marketable

advertising.trade-fair-display-not-for-sale-notice
Fact-level verified

A medical device may be imported for display at trade fairs, exhibitions or demonstrations without undergoing conformity verification only on authorisation by the Director of the Instituto de Salud Pública, and a visible sign on the devices must clearly state that they cannot be commercialised or put into service until the applicable requirements have been met.

Conditions
  • This is the only provision in the device reglamento that conditions a promotional channel; it restricts how an unregistered device may be displayed, it does not create a general advertising approval.
  • The authorisation is granted by the ISP Director ('el Director del Instituto'), i.e. the Instituto de Salud Pública de Chile.

Effective from 1999-09-01

Source is Spanish. DS 825 was promulgated on 30.11.1998 and published in the Diario Oficial on 21.08.1999; art. 32 of the reglamento provides that it enters into force 'a contar del día 1º del mes siguiente a su publicación', hence effectiveFrom 01.09.1999. Quoted from the consolidated text on Ley Chile.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

Compare countries

Registration validity 3 years, auto-renewed

validity.three-years-auto-renewal
Fact-level verified

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 periods unless expressly revoked — i.e., no renewal application is required.

Conditions
  • Applies to the registro sanitario of devices under control (prestación 9100003).

Authority & regime

Which authority and binding regime govern this product, task, and date?

Compare countries

Competent authority

authority.competent-authority
Fact-level verified

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 quality for these products. Device regulation is implemented by ISP's Departamento Agencia Nacional de Dispositivos Médicos, Innovación y Desarrollo (ANDIM).

Conditions
  • Applies to all device classes and to IVDs (DMDIV).

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

Compare countries

Change notification duty under DE 25/2026

changes.notification-duty-de25
Fact-level verified

Any device that, after verification of conformity and obtaining the registro sanitario, undergoes modifications in design, manufacture, intended use, raw materials or components, performance, labeling or other relevant characteristics must notify ISP; if the modification is significant, a new registro sanitario is required.

Conditions
  • Applies to devices incorporated by Decreto Exento 25/2026.

Significant change requires new registration

changes.significant-requires-new-registration
Fact-level verified

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 device's safety and/or performance, or that imply alterations in design, chemical composition of the manufacturing material or main component, biocompatibility, energy source or manufacturing processes — those cases constitute a new registro sanitario. A modification prestación exists (catalog code 9100017).

Conditions
  • Applies to registered DM/DMDIV.

Classification rules

What local class follows from which rules and decisive product facts?

Compare countries

Classification detail 2

classification.detail-2
Fact-level verified

ISP's risk-classification guide (2nd ed., June 2018) applies 22 classification rules (non-invasive, invasive, active, additional) on IMDRF/GHTF principles; if several rules apply the highest class prevails (criterio 3.8); accessories are classified separately (3.9); software integral to equipment takes the equipment's class and standalone software is classified by its own rules (3.6); ISP may assign a different class based on historical market behavior (3.11); borderline devices take the higher class.

Classification detail 3

classification.detail-3
Fact-level verified

Class determines documentation/controls under D.S. 825/1998 Art. 21: Clase I — product/manufacturer/distributor identification, materials declaration, sterilization/storage data, background evidence of quality, performance evaluation per official norms, legalized export certificate for imports; Clase II — all of Clase I plus quality-system manufacturing certificate NCh-ISO 9002 or GMP; Clase III — Clase I plus supporting scientific literature, manufacturer safety/effectiveness studies, NCh-ISO 9001 or GMP certificate; Clase IV — Clase III plus studies in representative patient groups, study of all inherent risks, and biological studies.

Classification scheme (full axis)

classification.scheme-classes
Fact-level verified
Axis

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

Classes
  • Id

    i

    Label

    Clase I

    Normalized Risk Level

    low

  • Id

    ii

    Label

    Clase II

    Normalized Risk Level

    medium

  • Id

    iii

    Label

    Clase III

    Normalized Risk Level

    high

  • Id

    iv

    Label

    Clase IV

    Normalized Risk Level

    highest

Regulator

ISP

Notes
  • Art. 20 D.S. N°825/1998: devices are grouped into 4 classes by risk level associated with use (I very low, II moderate, III high potential, IV most critical).
  • ISP's risk-classification guide (2nd ed., June 2018, ispch.cl) applies 22 classification rules (non-invasive, invasive, active, additional) on IMDRF/GHTF principles; when several rules apply the highest class prevails (criterio 3.8); accessories are classified separately (3.9); software integral to equipment takes the equipment's class, standalone software by its own rules (3.6); ISP may assign a different class based on historical market behavior (3.11); borderline devices take the higher class.
  • Class scales documentation/controls under Art. 21 (Clase II adds quality-system manufacturing certificate NCh-ISO 9002 or GMP; Clase III adds scientific literature, safety/effectiveness studies, NCh-ISO 9001; Clase IV adds studies in representative patient groups, inherent-risk and biological studies).
  • Application is progressive via product-incorporation decrees listing devices and their class (Art. 22); currently 10 DM/DMDIV types require registration, extended by Decreto Exento 25/2026 (39 categories).

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

Compare countries

Authorization for investigational use

clinical.research-use-authorization
Fact-level verified

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 registered devices intended to be used differently from their registration. The application (after approval under Article 10 of Law N°20.120) includes the investigation protocol, informed-consent form, insurance policy and other regulatory documents; the authorization may not exceed 1 year, renewable for equal successive periods; ISP keeps a public registry of authorized studies.

Conditions
  • Applies to clinical/scientific investigation use of DM/DMDIV in humans.
  • The Ministry of Health may exempt low-risk elementos de uso médico from this requirement by decree supremo.
  • Products under the authorization may only be used for the authorized purpose; transfer/distribution for other use is prohibited.

Trial adverse-event notification duty

clinical.trial-adverse-event-notification
Fact-level verified

The authorization holder, sponsoring entity, principal investigator and the study center are responsible for notifying ISP and the corresponding Scientific Ethics Committee of adverse reactions and adverse events occurring during the study, within the time and form set by the respective regulation, and for complying with pharmacovigilance/tecnovigilance rules.

Conditions
  • Applies to authorized clinical investigations of devices.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

Compare countries

Borderline products decided by ISP

definition.borderline-regime-determination
Fact-level verified

For borderline products (between device, medicine, cosmetic, sanitary-use pesticide, etc.), ISP determines the applicable sanitary control regime by reasoned resolution (resolución fundada), based on D.S. N°3 Article 8; the determination is made where doubt exists about classification given the product's characteristics and intended use.

Conditions
  • Applies to medical devices/IVDs as stated.

IVD definition

definition.ivd
Fact-level verified

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, instrument, apparatus, equipment or system, intended by the manufacturer for in-vitro examination of samples from the human body (including blood/tissue donations) to provide information on a physiological or pathological state, congenital anomaly, or safety/compatibility with potential recipients.

Conditions
  • Applies to medical devices/IVDs as stated.

Medical device definition

definition.medical-device
Fact-level verified

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 combination and defined by the manufacturer for direct use in humans, whose principal intended action is not achieved by pharmacological, immunological or metabolic means; purposes include diagnosis, prevention, monitoring, treatment or alleviation of disease, investigation, replacement/modification of anatomy or a physiological process, and contraception.

Conditions
  • Applies to medical devices/IVDs as stated.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

Compare countries

AED-specific dossier documents

dossier.aed-specific-documents
Fact-level verified

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 local post-sale technical service; declaration of spare-parts and accessory assurance; technical and/or user manual; risk-management report and mitigation measures; biocompatibility report; operator/quick-start guide.

Conditions
  • Applies only to portable AEDs under Decreto Exento N°42/2021.

Common registration dossier documents

dossier.common-documents
Fact-level verified

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 defibrillators); (2) export or free-sale certificate from the country's health authority, consularized or apostilled; (3) manufacturer's document recognizing the applicant as authorized representative/distributor (not for local manufacturers); (4) manufacturer's quality-management-system certificate (ISO 13485, ISO 9001 or equivalent), consularized or apostilled; (5) sterility certificates of declared lots, when applicable, consularized or apostilled; (6) draft label; (7) draft instructions for use; (19) supporting scientific literature; (20) studies in representative patient groups or clinical investigations.

Conditions
  • Foreign documents must be consularized or apostilled.
  • Document set varies with device type (class/category).

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

Compare countries

Applicant: local manufacturer or authorized representative/titular

roles.applicant-representative-titular
Fact-level verified

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 has received and accepted a written mandate (power letter/letter of designation or signed contract) from a legal manufacturer located outside Chile to act on its behalf for its sanitary obligations before ISP; the registration is held under that representative's titularidad.

Conditions
  • Applies to all applications for DM/DMDIV registration.

Company enrollment prerequisite

roles.company-enrollment-prerequisites
Fact-level verified

Before filing for device registration, the company must have completed: company enrollment (Inscripción de Empresa), warehouse authorization (Autorización de Bodega), and the request for the Customs Destination Certificate (Certificado de Destinación Aduanera, CDA) for devices with sanitary registration. A company-enrollment prestación exists for manufacturers/exporters, importers and distributors together with the list of devices they market in Chile (catalog code 9100016).

Conditions
  • Applies to manufacturers, exporters, importers and distributors of devices under sanitary control.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

Compare countries

Import customs control

import.customs-control-cda
Fact-level verified

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 and disposition must be authorized by ISP.

Conditions
  • Applies to imported devices under sanitary control.

Current practice per Ficha 9100003: CDA requested via GICONA; an 'Autorización de Uso y Disposición' issued by ISP is also required to obtain conformity-verification certificates (Nota 1).

Warehouse sanitary authorization

import.warehouse-sanitary-authorization
Fact-level verified

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 (regional health authority) or by ISP; warehouse entry into GICONA is processed via giconaprocesos@ispch.cl. A specific prestación covers authorization of installation, operation or modification of device storage warehouses (catalog code 9200007).

Conditions
  • Applies to companies importing/marketing devices under sanitary control.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

Compare countries

Label/IFU language rules for HIV IVDs

label.language-rules-hiv-selftest
Fact-level verified

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 be supplied in the Spanish version used for marketing in Chile (for imported products the English version is also submitted); for self-tests, the prospectus must be provided to the user printed and in Spanish mandatorily; documents in a language other than Spanish require a simple translation under sworn declaration.

Conditions
  • Stated for DMDIV HIV self-test/professional-test registration applications; instructivo-specific.

Also from the same instructivo: 'El prospecto debe ser proporcionado al usuario en formato impreso y en idioma castellano obligatoriamente.'

Verification statement on product or packaging

label.verification-mark
Fact-level verified

Devices subject to conformity verification must state, legibly on the product itself or its packaging, that they have been verified and the number assigned by ISP; where product nature/size makes this impossible, ISP may exempt or substitute the indication by resolution.

Conditions
  • Applies to medical devices/IVDs as stated.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

Compare countries

Manufacturer investigation report within 6 months

pms.investigation-report-deadline
Fact-level verified

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, risk evaluation, corrective/preventive actions and follow-up); the deadline to submit the follow-up and final report to ISP is a maximum of 6 months from the communication to ISP.

Conditions
  • Applies to legal manufacturers, importers and authorized representatives of DM/DMDIV.
  • ISP may request progress information or the final report earlier depending on severity.

Official forms & portals

Which current form, portal, account, and submission package must be used?

Compare countries

Electronic filing platforms (SAFIS/GICONA)

forms.electronic-filing-platforms
Fact-level verified
Submission Surface

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 payment through the SAFIS platform (safis.ispch.gob.cl) using clave única, with the resolution delivered in SAFIS 'Trámites Finalizados'; CDA applications run through GICONA.

Exceptions

Registration of HIV-detection IVDs (autotest) is filed in person at the Sección Gestión Productos y Servicios, ISP, Av. Marathon 1000, Ñuñoa, Santiago.

Conditions
  • Electronic route for covered products; in-person route only for the stated HIV IVD exception.

Baseline fact confirmed and refined: ANDIM page (opened) names GICONA for the electronic trámite ('se debe ingresar al sistema informático de tramitación en línea GICONA'); ficha 9100003 v02 names SAFIS as the current form/payment platform.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

Compare countries

QMS and risk standards basis under DE 25/2026

qms.de25-standards
Fact-level verified

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 16142-1 and NCh ISO 16142-2 (essential principles of safety and performance for DM and DMDIV), NCh ISO 13485 (quality management systems, regulatory purpose) and NCh ISO 14971 (application of risk management); product-specific norms in the decree's table apply where corresponding.

Conditions
  • Applies to the 39 categories incorporated by Decreto Exento 25/2026.

Manufacturer QMS certificate in dossier

qms.manufacturer-qms-certificate
Fact-level verified

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

Conditions
  • Applies to current registration applications (ficha 9100003).

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

Compare countries

FSCA notification and Spanish field-safety notice

recall.fsca-notification-and-fsn
Fact-level verified

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 Spanish, with a clear title (e.g. 'Retiro del Mercado'), identified recipients, device identification (model, lot, serial, expiry, manufacturer, country of origin), reasons/problem description and associated hazards. Market recalls must be communicated in writing to ISP immediately at the start of the recall process, and distribution records must be readily available to the manufacturer/importer/representative and to ISP on request.

Conditions
  • Applies to legal manufacturers, importers and authorized representatives conducting FSCA/recalls in Chile.

Same guide, recall-requirements list: 'Comunicar por escrito por medio del formulario, al ISP inmediatamente al inicio del proceso de retiro al correo tecnovigilancia@ispch.cl'.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

Categories requiring registro sanitario today

registration.current-mandatory-categories
Fact-level verified
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-examination latex gloves and latex condoms (Decreto Exento 342/2004); sterile single-use hypodermic needles and syringes (Decreto Exento 1887/2007); synthetic and female condoms (Decreto Exento 93/2018); portable automated external defibrillators (Decreto Exento 42/2021); HIV self-test IVDs (Decreto Exento 41/2022 and 96/2022); professional-use HIV detection IVDs (Decreto Exento 41/2022 and 15/2024).

Upcoming

Immunohematological reagents (Decreto Exento 5/2025, in force from 21 February 2026); 39 further categories (Decreto Exento 25/2026); blood-donation microbiological screening reagents (Decreto Exento 31/2026).

Conditions
  • Devices outside these categories are not currently subject to mandatory registration until the respective decrees take effect.

DE 25/2026 products need registro sanitario

registration.de25-mandatory-from-transition
Fact-level verified

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 verification of conformity, which for these purposes is a registro sanitario granted by ISP.

Conditions
  • Applies to the 39 categories listed in Art. primero.
  • Dates run per Art. primero transitorio from publication (19 March 2026); voluntary early registration allowed once the instructivo técnico is issued (Art. segundo transitorio).

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Chile approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Chile (5 records)

ChileEU conformity assessment

Prior approval / evidence record

CE Mark (EU MDR)

Authority

CE Mark (EU MDR)

Accepted

Yes

Benefit

Chile requires ISP registration only for the controlled device families; for everything else the certificate supports importation rather than a registration decision. Where registration does apply, the ISP period does not vary with origin.

Timeline Savings

None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

ChileSource authority not specified

Regulatory reference

Foreign export/free-sale certificate accepted

reliance.export-or-freesale-certificate
Fact-level verified

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 current ISP filing sheet equally requires an export or free-sale certificate from the competent health authority, consularized or apostilled.

Conditions
  • Applies to imported medical devices.

Ficha 9100003 'Documentos requeridos' n°2 states the same requirement in the form 'consularizado o apostillado'.

ChileSource authority not specified

Regulatory reference

Alternative international standards accepted

reliance.alternative-international-standards
Fact-level verified

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 alternative or complementary standards, national or international, in place of the specific standards listed in the decree; ISP will set criteria for recognizing updated standard versions by reasoned resolution (Art. tercero).

Conditions
  • Applies to devices incorporated by Decreto Exento 25/2026.

ISP news (20-03-2026): the ISP verification 'consistirá en la obtención del registro sanitario, sin exigencia de controles locales' — documentary review without local testing/controls.

ChileNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence
Pending verification
Statement

Decreto Supremo 825/1998 Art. 21 a) 6 requires, for every imported device subject to control, a certificate for export purposes issued in the country of origin, authorized by the corresponding state authority and duly legalized; an NMPA-issued export/free-sale certificate therefore satisfies this documentary requirement for China-made devices. Neither DS 825 nor Decreto Exento 25/2026 (which brought a further group of devices/IVDs under registration) names any foreign reference agency or provides an abridged review based on foreign approvals; conformity is verified by ISP against NCh-ISO 16142, 13485 and 14971 and product standards.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

chile

China Classes In Scope

NMPA Class I/II/III (all ISP classes I–IV, since Class I requirements apply cumulatively to higher classes)

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Applies to devices incorporated into the control regime by decree (Art. 22 DS 825; Decretos Exentos 342/2004, 1887/2007, 93/2018, 41/2022, 5/2025, 25/2026, 31/2026 etc.)
  • Certificate must be legalized (consular) or apostilled per current ISP practice
  • Decreto Exento 25/2026 Art. segundo lets the holder show conformity via alternative national or international standards, not via foreign approvals
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 1999-08-21

Source passage: 6. Certificado para propósitos de exportación otorgado en el país de origen, autorizado por la autoridad estatal correspondiente y debidamente legalizado, en el caso dispositivos médicos que se importen a Chile.

ChileUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

Yes

Benefit

Accepted as evidence of conformity alongside the certificate of free sale, with no published reduction.

Timeline Savings

None published

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Silence deemed approval

clocks.silence-deemed-approval
Fact-level verified

If the health authority does not pronounce within the applicable period, the authorization is deemed granted, except for matters that by law require express authorization (which cannot start operating without it).

Conditions
  • General Código Sanitario rule for authorizations/permits; whether device registration is an express-authorization matter is not stated in the source.

Statutory 30-working-day decision clock with one-shot cure

clocks.statutory-decision-30-days
Fact-level verified

Under Article 7 of the Código Sanitario, the health authority must decide on an authorization/permit application within 30 working days from filing; where there are formal observations, it may — only once — grant the applicant a deadline to cure or attach documents, failing which the application is deemed withdrawn; denial must be founded.

Conditions
  • General rule for authorizations/permits under the Código Sanitario.
  • ISP's published processing time for device registration (prestación 9100003) is 60 working days on average (see typedFindings).

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Emergency provisional sale/use authorization

special.emergency-provisional-use
Fact-level verified

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 population urgently requires the product.

Conditions
  • Requires a national emergency or urgent population need; granted by the ISP Director.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Written claims within 15 working days

appeal.claims-15-days
Fact-level verified

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). Separately, applicants for entity-authorization denied or not answered within 30 working days may claim in writing to the Ministry of Health within 15 working days (Art. 14), resolved by founded resolution.

Conditions
  • Art. 6: rejection in conformity verification; Art. 14: denial/silence on entity-authorization applications.

Second route quoted from Art. 14: 'podrán reclamar por escrito al Ministerio de Salud dentro del término de quince días hábiles'.

Deficiency handling and communications

communications.deficiency-notification
Fact-level verified

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 notified by email and is available in the 'Trámites Finalizados' section of the user's SAFIS account; queries run through the ISP online OIRS citizen-attention platform (siac.ispch.gob.cl).

Conditions
  • Applies to prestación 9100003 filings (device registration).

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Distribution traceability records

traceability.distribution-records
Fact-level verified

Storage/distribution establishments must keep distribution records sufficient for traceability (recipient location/name/address, batch number, manufacture and expiry dates, quantity distributed) to support complaints, adverse events and market recall; traceability records must be kept for no less than the device's shelf life, and never less than 2 years from product release; records must be available for inspection.

Conditions
  • Applies to establishments storing/distributing DM/DMDIV (BPA guide).

Record retention generally at least 1 year beyond shelf life of the longest-validated device stored.

Implantable-device traceability registry

traceability.implantables-registry
Fact-level verified

Establishments must keep a traceability registry for all implantable devices considered high risk for the patient, specifically: cardiac implants and central circulatory-system vascular implants; central nervous system implants and neurostimulation systems; spinal implants; hip, shoulder and knee prostheses; mammary implants; intraocular lenses; auditory implants; intragastric balloons; and others designated by ISP resolution. For implantable devices the minimum record-retention period is 10 years.

Conditions
  • Applies to storage/distribution establishments handling the listed implant categories.

Retention: 'En el caso de DM implantables el periodo mínimo de retención es de 10 años.' (sección 5.2).

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Statutory notification duty of health institutions

vigilance.institutional-notification-duty
Fact-level verified

Public or private health institutions using devices governed by D.S. N°825/1998 must communicate to ISP any defective behavior, failure or deterioration of characteristics or functioning, as well as missing label or instructions-for-use information that directly or indirectly could or could have led to a patient's or user's death or health deterioration.

Conditions
  • Applies to health-care institutions using regulated devices.

Vigilance notification deadlines

vigilance.notification-deadlines
Fact-level verified
Serious Events Or Sentinel

As soon as possible and no later than 3 working days (días hábiles) from becoming aware

Adverse Events

As soon as possible and no later than 30 working days

Incident Trends

Adverse incidents showing increased occurrence: no later than 30 days after analysis/validation by the tecnovigilance responsible

Conditions
  • Deadlines counted from knowledge of the event; guide-level rule of the National Tecnovigilance System.

Reportable events, forms and channel

vigilance.reportable-events-and-forms
Fact-level verified

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 forms on its website: ANDID/006 (health-care providers), ANDID/008 (legal manufacturer, authorized representative or importer), ANDID/010 (DMDIV-associated events) and ANDID/012 (FSCA communication), sent by the responsible tecnovigilance officer to tecnovigilancia@ispch.cl; providers also send complete forms to their Servicio de Salud and to the manufacturer/importer/representative. Non-notifiable situations include expected/probable occurrence and events associated with abnormal use of the device.

Conditions
  • Applies to the National Tecnovigilance System participants (providers, manufacturers, importers, authorized representatives).

Related structured datasets

Classification systems · 1 record
Open Risk classes I through IV for conformity-verification purposes (D.S. 825/1998). →
Id

chile:medical-device

Jurisdiction Id

chile

Domains
  • medical-device
Name

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

Classes
  • Id

    i

    Label

    Clase I

    Normalized Risk Level

    low

  • Id

    ii

    Label

    Clase II

    Normalized Risk Level

    medium

  • Id

    iii

    Label

    Clase III

    Normalized Risk Level

    high

  • Id

    iv

    Label

    Clase IV

    Normalized Risk Level

    highest

Regulator

ISP

Official Domains
  • ispch.cl
  • bcn.cl
  • leychile.cl
Notes
  • Art. 20 D.S. N°825/1998: devices are grouped into 4 classes by risk level associated with use (I very low, II moderate, III high potential, IV most critical).
  • ISP's risk-classification guide (2nd ed., June 2018, ispch.cl) applies 22 classification rules (non-invasive, invasive, active, additional) on IMDRF/GHTF principles; when several rules apply the highest class prevails (criterio 3.8); accessories are classified separately (3.9); software integral to equipment takes the equipment's class, standalone software by its own rules (3.6); ISP may assign a different class based on historical market behavior (3.11); borderline devices take the higher class.
  • Class scales documentation/controls under Art. 21 (Clase II adds quality-system manufacturing certificate NCh-ISO 9002 or GMP; Clase III adds scientific literature, safety/effectiveness studies, NCh-ISO 9001; Clase IV adds studies in representative patient groups, inherent-risk and biological studies).
  • Application is progressive via product-incorporation decrees listing devices and their class (Art. 22); currently 10 DM/DMDIV types require registration, extended by Decreto Exento 25/2026 (39 categories).
Source Status

official-source-verified

Source Title

D.S. N°825/1998, Art. 20 (reglamento de dispositivos y elementos médicos)

Source Url

https://www.bcn.cl/leychile/navegar?idNorma=141005

Verified On

2026-08-25

Source Supports
  • class-axis
Registration pathways, prior approvals and planning · 1 record
Open Chile registration →
Country

Chile

Jurisdiction Id

chile

Country Code

CL

Flag

🇨🇱

Regulator

Public Health Institute of Chile

Regulator Abbrev

ISP/ANDIM

Region

americas

Tier

3

Risk Classification

4-class (I, II, III, IV) — D.S. 102/2014

Classes
  • Id

    isp-registration

    Class Name

    ISP sanitary registration (medical devices)

    Pathway

    ISP registration

    Official Timeline
    Min

    60

    Max

    60

    Unit

    working-days

    Realistic Timeline
    Min

    3

    Max

    5

    Unit

    months

    Notes
    • ISP ficha 9100003 v03: 60 working days on average, provided no new documents are requested; the clock is a service-charter average rather than a statutory maximum
    • The ficha allocates a single clock to the whole route and does not split it by risk class
    • Applies only to the device categories placed under sanitary control by decree, not to devices generally
    Gmp Required

    Yes

    Verification Status

    official-verified

    Official Source
    Title

    ISP Chile ficha 9100003 v03 (25-09-2025) — registro sanitario de dispositivos médicos: 60 días hábiles en promedio, vigencia 3 años

    Url

    https://www.ispch.cl/wp-content/uploads/prestaciones/30725/9100003_v3.pdf

    Accessed Date

    2026-08-30

  • Id

    isp-ivd-registration

    Class Name

    ISP sanitary registration (in vitro diagnostics)

    Pathway

    ISP registration

    Official Timeline
    Min

    60

    Max

    60

    Unit

    working-days

    Realistic Timeline
    Min

    3

    Max

    5

    Unit

    months

    Notes
    • ISP ficha 9100019 v08: 60 working days on average counted from the date evaluation starts, provided no new documents are requested
    • HIV self-test applications must be filed on paper at Av. Marathon 1000; the remaining IVD routes run through the GICONA portal
    • An ISP conformity-verification certificate is a documentary prerequisite for the professional-use HIV assay route
    Gmp Required

    Yes

    Verification Status

    official-verified

    Official Source
    Title

    ISP Chile ficha 9100019 v08 (01-07-2026) — registro sanitario de DMDIV: 60 días hábiles en promedio desde el inicio de la evaluación

    Url

    https://www.ispch.cl/wp-content/uploads/prestaciones/2110169/9100019.pdf

    Accessed Date

    2026-08-30

Key Requirements
  • Registration is category-scoped rather than universal: only the products a decree has placed under sanitary control need an ISP registration, currently latex surgical and examination gloves, latex and synthetic male condoms, female condoms, sterile single-use hypodermic needles and syringes, portable AEDs, HIV self-tests and professional HIV assays, and immunohaematology reagents
  • Decreto Exento 25/2026 adds further device and IVD categories to that list with staged application dates, so products outside the current list should plan for a registration clock they do not yet face (the decree's product tables are image-only, so the category count and dates are not asserted here)
  • Three prerequisites gate the registration file and carry their own published clocks: company inscription (ficha 9100016, 25 working days, indefinite validity), warehouse authorisation (ficha 9200007, 45 working days in the Región Metropolitana and 60 working days elsewhere, 5-year validity), and the customs-destination certificate (CDA) obtained through GICONA
  • Local Authorized Representative (Chilean legal representative) holding the registration on the foreign manufacturer's behalf under a written mandate
  • Free-sale certificate, ISO 13485 evidence and manufacturer designation letters must be consularised or apostilled
  • Changes that alter design, material chemistry, principal component, biocompatibility, energy source or manufacturing process are treated as a new registration rather than a modification
Prior Approvals
  • Authority

    CE Mark (EU MDR)

    Accepted

    Yes

    Benefit

    Chile requires ISP registration only for the controlled device families; for everything else the certificate supports importation rather than a registration decision. Where registration does apply, the ISP period does not vary with origin.

    Timeline Savings

    None published

  • Authority

    FDA 510(k)/PMA

    Accepted

    Yes

    Benefit

    Accepted as evidence of conformity alongside the certificate of free sale, with no published reduction.

    Timeline Savings

    None published

Local Rep Required

Yes

Local Rep Name

Chilean Legal Representative

Mdsap Accepted

Yes

Mdsap Benefit

Accepted as QMS evidence

Registration Validity

3 years under Código Sanitario art. 7, automatically and successively extended for equal periods unless expressly revoked

Last Updated

2026-08-30

Verification Status

official-verified

Official Sources
  • Title

    ISP Chile ficha 9100003 v03 (25-09-2025) — registro sanitario de dispositivos médicos: 60 días hábiles en promedio, vigencia 3 años

    Url

    https://www.ispch.cl/wp-content/uploads/prestaciones/30725/9100003_v3.pdf

    Accessed Date

    2026-08-30

  • Title

    ISP Chile ficha 9100019 v08 (01-07-2026) — registro sanitario de DMDIV: 60 días hábiles en promedio desde el inicio de la evaluación

    Url

    https://www.ispch.cl/wp-content/uploads/prestaciones/2110169/9100019.pdf

    Accessed Date

    2026-08-30

  • Title

    ISP Chile ficha 9100016 v02 (28-08-2024) — inscripción de empresa: 25 días hábiles en promedio, vigencia indefinida

    Url

    https://www.ispch.cl/wp-content/uploads/prestaciones/30727/9100016.pdf

    Accessed Date

    2026-08-30

  • Title

    ISP Chile ficha 9200007 v2 (21-07-2025) — autorización de bodega: 45 días hábiles Región Metropolitana, 60 días hábiles regiones

    Url

    https://www.ispch.cl/wp-content/uploads/prestaciones/30735/9200007_v2.pdf

    Accessed Date

    2026-08-30

  • Title

    ISP Chile ANDIM — registro sanitario de DM y DMDIV: lista de categorías bajo registro obligatorio por decreto

    Url

    https://www.ispch.cl/andim/registro-y-autorizacion/registro/

    Accessed Date

    2026-08-30

Reviewed On

2026-08-30

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by ISP/ANDIM. Appoint a Chilean Legal Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to ISP/ANDIM including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    ISP/ANDIM reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. ISP/ANDIM may issue questions.

    Duration

    60 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, ISP/ANDIM issues Chile market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Chile fees →
Jurisdiction Id

chile

Country

Chile

Country Code

CL

Authority

ISP/ANDIM

Low Risk Local
Min

165628

Max

165628

Currency

CLP

Per Product

Yes

High Risk Local
Min

487880

Max

487880

Currency

CLP

Per Product

Yes

Details
  • Id

    dossier-review

    Item

    Registration dossier review (item 9100002)

    Currency

    CLP

    Amount Local

    487880

    Amount Local Formatted

    CLP 487,880

    Frequency

    Per dossier

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ispch.cl/productos-y-servicios/prestaciones?buscar=dispositivos

    Source Title

    ISP Chile Aranceles Prestaciones 2025: medical-device service fees

    Source Effective Date

    2025-01-01

    Verified On

    2026-08-25

  • Id

    registration-authorization

    Item

    Registration authorization (item 9100003)

    Currency

    CLP

    Amount Local

    165628

    Amount Local Formatted

    CLP 165,628

    Frequency

    Per authorization

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ispch.cl/productos-y-servicios/prestaciones?buscar=dispositivos

    Source Title

    ISP Chile Aranceles Prestaciones 2025: medical-device service fees

    Source Effective Date

    2025-01-01

    Verified On

    2026-08-25

  • Id

    company-inscription

    Item

    Company inscription (item 9100016)

    Currency

    CLP

    Amount Local

    311935

    Amount Local Formatted

    CLP 311,935

    Frequency

    Per company

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ispch.cl/productos-y-servicios/prestaciones?buscar=dispositivos

    Source Title

    ISP Chile Aranceles Prestaciones 2025: medical-device service fees

    Source Effective Date

    2025-01-01

    Verified On

    2026-08-25

  • Id

    registration-modification

    Item

    Registration modification (item 9100017)

    Currency

    CLP

    Amount Local

    69321

    Amount Local Formatted

    CLP 69,321

    Frequency

    Per modification

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ispch.cl/productos-y-servicios/prestaciones?buscar=dispositivos

    Source Title

    ISP Chile Aranceles Prestaciones 2025: medical-device service fees

    Source Effective Date

    2025-01-01

    Verified On

    2026-08-25

  • Id

    dmdiv-hiv-registration

    Item

    DMDIV (HIV) registration (item 9100018)

    Currency

    CLP

    Amount Local

    5776551

    Amount Local Formatted

    CLP 5,776,551

    Frequency

    Per registration

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ispch.cl/productos-y-servicios/prestaciones?buscar=dispositivos

    Source Title

    ISP Chile Aranceles Prestaciones 2025: medical-device service fees

    Source Effective Date

    2025-01-01

    Verified On

    2026-08-25

  • Id

    dmdiv-hiv-authorization

    Item

    DMDIV (HIV) authorization (item 9100019)

    Currency

    CLP

    Amount Local

    487880

    Amount Local Formatted

    CLP 487,880

    Frequency

    Per authorization

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ispch.cl/productos-y-servicios/prestaciones?buscar=dispositivos

    Source Title

    ISP Chile Aranceles Prestaciones 2025: medical-device service fees

    Source Effective Date

    2025-01-01

    Verified On

    2026-08-25

  • Id

    export-certificate

    Item

    Export certificate (item 9200001)

    Currency

    CLP

    Amount Local

    71022

    Amount Local Formatted

    CLP 71,022

    Frequency

    Per certificate

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ispch.cl/productos-y-servicios/prestaciones?buscar=dispositivos

    Source Title

    ISP Chile Aranceles Prestaciones 2025: medical-device service fees

    Source Effective Date

    2025-01-01

    Verified On

    2026-08-25

  • Id

    warehouse-authorization

    Item

    Warehouse authorization (item 9200007)

    Currency

    CLP

    Amount Local

    911573

    Amount Local Formatted

    CLP 911,573

    Frequency

    Per authorization

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ispch.cl/productos-y-servicios/prestaciones?buscar=dispositivos

    Source Title

    ISP Chile Aranceles Prestaciones 2025: medical-device service fees

    Source Effective Date

    2025-01-01

    Verified On

    2026-08-25

  • Id

    stock-exhaustion-authorization

    Item

    Stock-exhaustion authorization (item 9200010)

    Currency

    CLP

    Amount Local

    80872

    Amount Local Formatted

    CLP 80,872

    Frequency

    Per authorization

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ispch.cl/productos-y-servicios/prestaciones?buscar=dispositivos

    Source Title

    ISP Chile Aranceles Prestaciones 2025: medical-device service fees

    Source Effective Date

    2025-01-01

    Verified On

    2026-08-25

  • Id

    technovigilance-inscription

    Item

    Technovigilance inscription (item 9500000)

    Currency

    CLP

    Amount Local

    71948

    Amount Local Formatted

    CLP 71,948

    Frequency

    Per inscription

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ispch.cl/productos-y-servicios/prestaciones?buscar=dispositivos

    Source Title

    ISP Chile Aranceles Prestaciones 2025: medical-device service fees

    Source Effective Date

    2025-01-01

    Verified On

    2026-08-25

  • Id

    technovigilance-modification

    Item

    Technovigilance modification (item 9500001)

    Currency

    CLP

    Amount Local

    39456

    Amount Local Formatted

    CLP 39,456

    Frequency

    Per modification

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.ispch.cl/productos-y-servicios/prestaciones?buscar=dispositivos

    Source Title

    ISP Chile Aranceles Prestaciones 2025: medical-device service fees

    Source Effective Date

    2025-01-01

    Verified On

    2026-08-25

Notes
  • All ISP tariff amounts are exclusive of IVA (VAT), which is added at invoicing.
  • Item numbers are the official tariff (arancel) codes effective 2025.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    ISP Chile Aranceles Prestaciones 2025: medical-device service fees

    Url

    https://www.ispch.cl/productos-y-servicios/prestaciones?buscar=dispositivos

    Effective Date

    2025-01-01

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Chile certifications →
Slug

chile

Market

Chile

Confidence

high

Schemes
  • Id

    isp-nch-norms-documentary-verification

    Name

    ISP NCh-norm documentary verification

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Decreto Exento N° 25/2026 names NCh ISO 16142-1/2 (essential principles of safety and performance), NCh ISO 13485 (QMS) and NCh ISO 14971 (risk management) as the technical-norm basis of ISP documentary verification, plus product-specific norms listed in the decree table; alternative or complementary national/international standards are accepted where the decree norms are not met directly (Art. segundo, final paragraph); class-based technical evaluation runs per official Chilean (INN) norms or MINSAL-approved international norms (D.S. 825 Art. 21 a)5).

    Source Binding

    unresolved

  • Id

    product-specific-iec-and-sterility-certificates

    Name

    Product-specific IEC and sterility certificates

    Category

    Product Specific Conformity

    Status

    Included In Medical Registration

    Object

    Listed Product Category

    Note

    Ficha 9100003 items 8-11: portable AEDs require IEC 60601-1, IEC 60601-2-4 and IEC 60601-1-2 compliance certificates in the registration dossier; item 5 requires sterility certificates for declared lots (consularized or apostilled) when applicable.

    Source Urls
    • https://www.ispch.cl/wp-content/uploads/prestaciones/30725/9100003.pdf
    Source Binding

    reviewed

  • Id

    subtel-srd-medical-certificate-and-qr

    Name

    SUBTEL short-range radio certificate or QR marking

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Short Range Radio Equipment

    Note

    Ley 18.168 Art. 7° charges MTT with the technical rules so that equipment generating electromagnetic waves does not cause harmful interference. The current short-range technical standard is the 10 July 2026 texto refundido of Resolución Exenta N° 1.985/2017 (Resolución Exenta N° 1.247/2026). Art. 2(1) requires a SUBTEL certificate, before sale or any transfer for use in Chile, for the Art. 1 literales g and h equipment: Medical Implant Communication Systems (MICS) in 401-406 MHz, 2.400-2.483,5 MHz, 430-440 MHz medical data-acquisition devices and 9-315 kHz extremely-low-power active implants, plus other equipment used for medical applications in the listed bands. That certificate does not authorise medical use. Art. 2(2) requires the remaining SRD categories (a-f, i-k) to hold a test report and carry a QR code on the outer packaging before they are commercialised.

    Source Urls
    • https://www.bcn.cl/leychile/navegar?idNorma=1225920
    Source Binding

    reviewed

  • Id

    ds133-ionizing-generator-authorization

    Name

    DS 133 ionizing-generator and radioactive-substance authorisation

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Ionizing Generator Or Radioactive Substance

    Note

    Decreto Supremo N° 133/1984 Art. 2° forbids radioactive installations or equipment that generates ionizing radiation from operating without prior authorisation of the Health Service of the territory (the environmental health service in the Región Metropolitana). Art. 3° requires an individual authorisation for anyone who works in those installations or operates such equipment and is exposed. Art. 4° forbids acquiring, possessing, using, storing, importing, exporting, distributing or selling radioactive substances without the corresponding sanitary authorisation. This is a use-site and substance gate, not an ISP product-registration certificate.

    Source Urls
    • https://www.bcn.cl/leychile/navegar?idNorma=9794
    Source Binding

    reviewed

  • Id

    ds298-sec-protocol-certification

    Name

    SEC protocol certification before commercialisation

    Category

    General Electrical Components

    Status

    Mandatory If Feature

    Object

    Electrical Product On A Sec Protocol

    Note

    Decreto Supremo N° 298/2005 Art. 1° sets the procedure for certifying electrical and fuel products for safety and quality before they are commercialised. Art. 2° applies that procedure to every electrical product that current rules require to be certified before sale, whatever its use or field of application, and to the importers, manufacturers and sellers of those products. No PE protocol naming electromedical equipment was read in this pass, so the scheme is the live SEC protocol list rather than a blanket medical-device certificate. Art. 9° is only the fallback where no authorised certification body exists for a listed product.

    Source Urls
    • https://www.bcn.cl/leychile/navegar?idNorma=246921
    Source Binding

    reviewed

  • Id

    ds22-rep-aee-and-batteries-producer

    Name

    REP producer registration for AEE and batteries

    Category

    Environmental And Batteries

    Status

    Mandatory If Feature

    Object

    Producer Introducing Aee Or Batteries

    Note

    Ley 20.920 Art. 10 lists aparatos eléctricos y electrónicos, baterías and pilas as priority products. Decreto Supremo N° 22 of 7 May 2026 is the metas decree for pilas and AEE. Art. 3° applies it to every pila and AEE placed on the national market; the exclusions (military, large fixed industrial tools, large fixed installations, vehicles needing a circulation permit, professional off-road mobile machinery, R&D-only professional AEE, components of an excluded apparatus, and cells destined only for larger batteries) do not name medical devices. Art. 4° puts non-AIT, non-photovoltaic AEE in the residual category 'Otros aparatos eléctricos y electrónicos'. Art. 6° and 8° require producers who introduce pilas and/or AEE to enrol in Ventanilla Única del RETC and, except micro-enterprises, to organise collection and meet the metas through a management system; a first-time introducer has four months from first placing to complete the RETC inscription. Art. 49 brings Título II into force on publication (7 May 2026) and postpones Títulos III and IV (the metas themselves) by 24 months, so 7 May 2028.

    Source Urls
    • https://www.bcn.cl/leychile/navegar?idNorma=1223902
    Source Binding

    reviewed

Official Sources
  • Authority

    Biblioteca del Congreso Nacional de Chile

    Topic

    Decreto Exento N° 25/2026 technical norms NCh ISO 16142-1/2, 13485, 14971

    Url

    https://www.bcn.cl/leychile/navegar?idNorma=1222514

  • Authority

    Instituto de Salud Pública de Chile

    Topic

    Ficha 9100003 required documents — IEC 60601 certificates and sterility certificates

    Url

    https://www.ispch.cl/wp-content/uploads/prestaciones/30725/9100003.pdf

  • Authority

    Biblioteca del Congreso Nacional de Chile

    Topic

    Ley 18.168 Art. 7° MTT interference rules for radiating equipment

    Url

    https://www.bcn.cl/leychile/navegar?idNorma=29591

  • Authority

    Biblioteca del Congreso Nacional de Chile

    Topic

    Resolución Exenta N° 1.247/2026 texto refundido of the short-range technical standard, Arts. 1 g-h and 2

    Url

    https://www.bcn.cl/leychile/navegar?idNorma=1225920

  • Authority

    Biblioteca del Congreso Nacional de Chile

    Topic

    Decreto Supremo N° 133/1984 Arts. 2-4 ionizing-generator and radioactive-substance authorisation

    Url

    https://www.bcn.cl/leychile/navegar?idNorma=9794

  • Authority

    Biblioteca del Congreso Nacional de Chile

    Topic

    Decreto Supremo N° 298/2005 Arts. 1-2 and 9 SEC certification before commercialisation

    Url

    https://www.bcn.cl/leychile/navegar?idNorma=246921

  • Authority

    Biblioteca del Congreso Nacional de Chile

    Topic

    Decreto Supremo N° 22/2026 Arts. 3-4, 6, 8 and 49 REP producer duties for pilas and AEE

    Url

    https://www.bcn.cl/leychile/navegar?idNorma=1223902

Keep researching this market
View the Chile resource hub →
DJ Fang
Need to apply Chile's requirements to a product?
Confirm the current ISP/ANDIM pathway, evidence, and local-role details for the actual device before filing.
Pricing