Medical devices are the only short-range category that still requires formal SUBTEL certification after Resolution 737. It is exactly the filing Certificación Telecom has made for every category for 22 years, since 2004, before Resolution 737 replaced it with self-declaration for everything else. We handle the request end to end: we review the test report against the standard, assemble the technical file and take it through to the Oficio de Certificación.
Because Resolution 737 decided it that way. The point of the reform was to lighten the regulatory load on consumer devices, whose interference risk is low and whose volume of requests had become unmanageable with the rise of 5G and IoT. For medical devices, the standard kept prior control in place.
The result is that two regimes now coexist under the same technical standard: formal certification for literales g) and h), self-declaration with a QR code for everything else.
Se estima procedente reservar el trámite de certificación solamente para equipos de alcance reducido destinados a aplicaciones médicas.
It is deemed appropriate to reserve the certification procedure only for short-range devices intended for medical applications. (Unofficial translation.)
Literales g) and h) of article 1 of the technical standard. Specifically:
| Literal | Devices | Band | Maximum power |
|---|---|---|---|
| g.1 | Medical implants (MICS): pacemakers, insulin pumps, neurostimulators, cochlear implants | 401 - 406 MHz | 25 µW EIRP |
| g.2 | Medical devices at 2.4 GHz, with frequency hopping | 2,400 - 2,483.5 MHz | 2.5 mW radiated |
| g.3 | Medical data acquisition devices, with frequency hopping | 430 - 440 MHz | 0.1 µW EIRP |
| h | Other medical equipment: telemetry and biomedical devices that are not implants | 9 - 70 kHz · 140 - 200 kHz · 13.553 - 13.567 MHz · 608 - 614 MHz · 902 - 928 MHz | Depends on band |
Literal g.3 was added by Resolution 2219 and has been in force since 24 November 2025, ahead of the rest of the reform: medical data acquisition devices can already be certified.
Obtaining a certificate from SUBTEL before selling or transferring the device, on any basis, for use in the country. It is not a self-declaration and not a QR code: it is prior authorization.
Todo fabricante o importador de equipos descritos en los literales g) y h) del artículo 1°, antes de venderlos o cederlos a terceros, a cualquier título, para su uso dentro del país, debe obtener un certificado de la Subsecretaría de Telecomunicaciones acreditando el cumplimiento de las disposiciones de la presente norma técnica en materia de emisiones radioeléctricas. Las certificaciones de equipos que se otorguen conforme la presente norma técnica no autorizan, en ningún caso, su utilización para fines médicos.
Every manufacturer or importer of equipment described in literales g) and h) of article 1, before selling it or transferring it to third parties, on any basis, for use within the country, must obtain a certificate from the Undersecretariat of Telecommunications attesting compliance with this technical standard regarding radio emissions. Certificates granted under this technical standard do not, under any circumstance, authorize the equipment's use for medical purposes. (Unofficial translation.)
The article says so itself, and it is worth being clear about before starting: SUBTEL certification attests compliance on radio emissions and nothing else. Health-authority approval of the device is a separate process, and we do not handle it.
Put differently: our work covers the device's radio, not the device as a medical product.
If you are considering entering Chile with a medical device, this is where most projects lose time: the two processes are independent, and it is worth starting them in parallel rather than in sequence.
We handle the full request before SUBTEL. This is the filing this company was built on, and the one we made for two decades across every kind of device, back when it applied to all of them.
Los Informes de Ensayo o Test Reports que el fabricante o importador debe presentar, según se indica en el artículo 2°, sólo serán aceptados si provienen de laboratorios que cuenten con al menos una acreditación internacional que asegure la calidad y objetividad de sus ensayos. Las acreditaciones correspondientes deberán estar estampadas en todas las páginas del respectivo Informe de Ensayo o Test Report.
The Informes de Ensayo or Test Reports that the manufacturer or importer must present, as indicated in article 2, will only be accepted if they come from laboratories holding at least one international accreditation ensuring the quality and objectivity of their testing. The corresponding accreditations must be stamped on every page of the respective Informe de Ensayo or Test Report. (Unofficial translation.)
We do not commit to a turnaround on this service: processing times are set by SUBTEL, not by us. The two-business-day turnaround we offer applies to self-declared compliance, which is a different process.
Write to us with the device, the band it operates in and its test report. We will confirm whether it requires certification and what the filing involves.
Ask about a medical deviceCompliance page and QR code for WiFi, Bluetooth, Zigbee, RFID and IoT devices. The regime that applies to almost every wireless device.
For manufacturers with no Chilean entity. The standard requires a manufacturer, importer or representative with legal domicile in the country, with no exceptions.