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Does my medical device need SUBTEL short-range radio certificate or QR marking in Chile?

Describe your device to check whether SUBTEL short-range radio certificate or QR marking may apply, why, what facts are missing, and which official source to review.

6 maintained routes7 official source links

Preliminary applicability · country-specific scope

What you receive

Not just a yes or no

A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.

Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.

Official starting points. Open the regulator or government sources behind the maintained country matrix.

Maintained country rule

What this SUBTEL short-range radio certificate or QR marking check is screening

Checks Wi-Fi, Bluetooth, cellular, NFC, RFID, UWB, telemetry, and proprietary radio approval. Applies when the product, feature, component, or use is in scope.

Requirement family: Radio and spectrum approval
Regulatory object: short range radio equipment
Maintained rule status: mandatory if feature
Useful product facts: Radio technologies, bands, power, antenna, module model, approval IDs, and host integration changes.

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.

How to read the answer

Classification is only the first layer

A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

Dossier or import evidence

Testing can belong inside the medical dossier, while some documents apply to each shipment.

Site or operator licence

Radiation, installation, use, or measurement controls may apply to a facility or operator.

Country-specific scope

Other Chile routes to check

Check every Chile route →

Electrical safety

ISP NCh-norm documentary verification

Evidence is normally handled inside the medical-device registration route.

Product-specific

Product-specific IEC and sterility certificates

Evidence is normally handled inside the medical-device registration route.

Radiation

DS 133 ionizing-generator and radioactive-substance authorisation

Applies to the facility, operator, or installation rather than only the product.

Adapters / components

SEC protocol certification before commercialisation

Applies when the product, feature, component, or use is in scope.

Environmental / battery

REP producer registration for AEE and batteries

Applies when the product, feature, component, or use is in scope.

Official starting points

Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.

Biblioteca del Congreso Nacional de Chile

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

About this checker

A preliminary tool, not a regulatory determination

Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Chile scheme matrix and links each route to its official source.

Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.

Is this the same as medical device classification in Chile?: No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
Does “no separate certificate” mean no testing is required?: No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
Is the result an official regulatory determination?: No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.