ISP/ANDIM · structured requirements

🇨🇱 Chile IVD regulatory data

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

13 facts5 dimensions14 official sourceslatest verification 2026-10-21

Changes after registration

Common questions about changing a registered IVD in Chile. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Source-linked rules available
How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
What changes when the manufacturer's office address changes? →Source-linked rules available
Does a catalogue or reference code change affect registration or UDI? →Source-linked rules available
Can a registration transfer to a different legal entity? →Source-linked rules available
Can several changes be filed together? →Source-linked rules available

Change control

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

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Check the actual Chilean product-control scope

changes.compulsory-control-product-scope

Fact-level verified

DS825 Art. 22 applies compulsory conformity control progressively through product-specific decrees. Being an MD or IVD does not by itself prove that the product already has a sanitary registration. Identify the actual ISP registration, conformity certificate or antecedent-review certificate before selecting a change service.

Conditions

Product-specific decrees and their commencement/transition provisions control scope.

IVD name, office address and product codes are reportable administrative changes

changes.ivd-administrative-name-office-code

Fact-level verified

ISP’s IVD guidance IVc.2 lists trade name, product code, legal-manufacturer corporate name/commercial address, plant corporate name, representative/holder particulars and holder transfer as reportable administrative changes. A legal-manufacturer name/commercial-address change without a plant-address change is administrative. Provide a sworn no-impact declaration, reasons and updated labels/IFU. A logo-only exemption is not expressly stated by this list.

Changed certificate details must match CFS and QMS evidence

changes.ivd-certificate-cfs-qms

Fact-level verified

For9200004 certificate modifications involving product name, models/codes or legal manufacturer, the current free-sale/export certificate must reflect the changed details. Imported certificates are legalized/apostilled. An export-only certificate saying the product is not authorized/marketed in its issuing country is insufficient without another official free-sale proof. The instructivo also requires current legal-manufacturer and applicable OEM/OBL/ODM/plant QMS evidence with at least six months remaining at filing, including assembly sites where applicable.

Conditions

This is the 9200004 IVD certificate branch; it is not a universal demand for every unrelated artwork update to obtain a new CFS or a new QMS certification.

IVD certificate modifications need an explicit change comparison

changes.ivd-certificate-comparison-materials

Fact-level verified

For9200004, the administrative-IVD instructivo requires a Spanish change report with comparison, justification and signatures, plus a sworn statement that no other changes are made. Provide highlighted primary/secondary labels and Spanish IFU, or signed unchanged documents; imported-product English and Spanish IFUs must correspond to the same current version.

Registered IVD name and holder-transfer materials

changes.ivd-registered-transfer-name-materials

Fact-level verified

The registered-IVD instructivo requires competent-authority corporate-name proof, constitution and amendments where applicable, a notarized holder-transfer agreement and explicit legal-manufacturer authorization for the requested modification. Submit only the change-specific documents, with foreign documents legalized/apostilled as stated. Manufacturer, holder and factory addresses are separate fields.

IVD filing follows the kind of ISP authorization

changes.ivd-two-change-services

Fact-level verified

For an IVD conformity or antecedent-review certificate, use service 9200004; for an issued sanitary registration, use9100017. The holder submits the appropriate form, a Spanish technical-notification report explaining the changes, supporting documents and a comparative table. ISP may require further assessment, new conformity verification or a new registration according to the change’s impact.

Product decrees have distinct commencement and change rules

changes.product-control-currentness

Fact-level verified

DE 47/2025 for its listed sterile single-use needles/syringes is in the current10October2026 expression and requires later relevant modifications to be notified, with possible renewed assessment. DE 25/2026 has product-specific24/36-month deferred implementation from its 19March2026 publication, with the stated conditional voluntary early route; DE 31/2026 blood-donation serology has12-month deferred implementation from 24March2026 and its own exclusions. Do not treat these future groups as if every device/IVD were already registered in October 2026.

Conditions

Match the actual product type and transition row. These transition periods are not variation review clocks.

Decreto Exento25/2026 — official Gazette eight pages Decreto Exento31/2026 — official Gazette four pages

Fees

What regulator fee applies to this class, route, event, and date?

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A registered-IVD form may select multiple changes with a charge for each

changes.ivd-registration-multiple-change-fees

Fact-level verified

Registered-IVD instructivo§6 allows selection of more than one modification but expressly says the tariff must be paid for each. The comparable MD instructivo allows multiple selections without that same sentence; do not silently extend the IVD charging statement to every MD or certificate service.

Descargar Instructivo para DM

Named modification services have a2026 net tariff

changes.modification-fees-2026

Fact-level verified

E1199’s2026 schedule sets9200004 certificate/antecedent modification and9100017 sanitary-registration modification at CLP69,321 net each. Company-enrollment modification9200003 is separately CLP69,321; warehouse corporate-name modification9200008 is CLP184,850. Applicable tax is additional. E1729 states commencement10April2026; a multi-change or multi-registration total is not established by the single service row.

E1729/2026 correcting E1199 fee commencement

Label, IFU & language

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

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Old stock requires a separate justified exceptional request

changes.exceptional-stock-application

Fact-level verified

ISP service 9200010 is an application for exceptional device-stock exhaustion with documents supporting and justifying the request, submitted through the SAFIS electronic form. Its published average is30 working days if no additional information is needed; an issued authorization is valid six months from its resolution. Neither period is an automatic stock grace for a name, brand or entity change. The 2026 fee schedule lists this service at CLP80,872 net plus applicable tax.

Resolución E1199/2026 tariff complete signed original

The service sheet retains a pharmaceutical/donation template phrase in workflow step13; it is not adopted as a device eligibility condition.

Reliance & recognition

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

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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 (3 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

ISP Chile ficha 9100003 v03 (25-09-2025) — registro sanitario de dispositivos médicos: 60 días hábiles en promedio, vigencia 3 años ISP Chile ficha 9100019 v08 (01-07-2026) — registro sanitario de DMDIV: 60 días hábiles en promedio desde el inicio de la evaluación ISP Chile ficha 9100016 v02 (28-08-2024) — inscripción de empresa: 25 días hábiles en promedio, vigencia indefinida ISP Chile ficha 9200007 v2 (21-07-2025) — autorización de bodega: 45 días hábiles Región Metropolitana, 60 días hábiles regiones ISP Chile ANDIM — registro sanitario de DM y DMDIV: lista de categorías bajo registro obligatorio por decreto

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

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?

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Certificate change service publishes its own conditional average

changes.certificate-change-average

Fact-level verified

The 9200004 technical sheet publishes45 working days on average only if new supporting information is not required. Its certificate validity is a separate period, not review time. Do not substitute conformity-provider authorization clocks or a registration’s validity for this modification estimate.

Registered change service publishes a conditional45-working-day average

changes.registration-change-average

Fact-level verified

The 9100017 technical sheet, version3 updated2January2026, publishes45 working days on average only if no new supporting information is required. Evaluation follows payment and may generate observations for correction. This is a service average, not a guaranteed statutory decision date or a period to add to another service automatically.

Related structured datasets

Classification systems · 0 records

No maintained record.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Chile registration →

Country

Chile

Jurisdiction Id

chile

Country Code

Flag

🇨🇱

Regulator

Public Health Institute of Chile

Regulator Abbrev

ISP/ANDIM

Region

americas

Tier

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Chile fees →

Jurisdiction Id

chile

Country

Chile

Country Code

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

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

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