ORBIS Compliance

Chile SUBTEL Updates Technical Standard for Short-Range Devices, QR Code Rules and Low-Power Active Implantable Medical Devices

Published /Effective /Chile

Chile’s Subsecretaría de Telecomunicaciones (SUBTEL) published Resolution Exenta N° 966/2026, modifying Resolution Exenta N° 1.985/2017, which establishes the Technical Standard for Short-Range Devices.

The update introduces three main regulatory changes. First, it adds a new category of equipment to the standard: active implantable medical devices of extremely low power operating in the 9–315 kHz frequency band, provided that the field strength does not exceed 30 dBµA/m, or its equivalent in dBµV/m, measured at 10 meters.

Second, the resolution modifies the QR code requirements applicable to devices covered by the short-range equipment standard. SUBTEL indicates that the objective is to facilitate the application of the QR code to a growing variety of devices while preserving the minimum conditions necessary for correct reading and functionality. The QR code size may now be freely determined by the responsible party, provided that proper readability and operation are ensured. The resolution also recommends compliance with ISO/IEC 18004, rather than imposing a fixed size requirement.

Third, the resolution introduces an alternative method for submitting confidential versions of test reports. Instead of only relying on publication or standard filing routes, the confidential version of the report may be submitted through SUBTEL’s Virtual Filing Office, indicating the corresponding entry number and equipment references to the institutional email address established for this purpose.

The modification reflects SUBTEL’s intention to modernize verification tools, reduce administrative friction for QR marking, and incorporate emerging low-power medical technologies into Chile’s telecommunications technical framework.

This is a medium-impact regulatory update because it introduces confirmed changes to Chile’s technical framework for short-range devices, but the scope is relatively targeted. The most relevant impacts are the incorporation of extremely low-power active implantable medical devices operating in the 9–315 kHz band, the flexibilization of QR code design requirements, and the new administrative option for submitting confidential test reports.

Key reasons for medium impact:

  • Confirmed regulatory change
    This is not a proposal or public consultation. Resolution Exenta N° 966/2026 was officially published and modifies the existing short-range device technical standard.
  • New device category added
    The regulation adds active implantable medical devices of extremely low power operating in 9–315 kHz, with a field-strength limit of 30 dBµA/m or equivalent at 10 meters.
  • QR code compliance flexibility
    The change reduces rigidity in QR code size and format requirements, allowing the responsible party to determine the QR size as long as readability and functionality are preserved.
  • Administrative simplification for confidential test reports
    The confidential version of test reports may now be submitted through SUBTEL’s Virtual Filing Office with the relevant entry number and equipment references.
  • Limited product scope
    The update does not overhaul the entire Chilean homologation or telecom approval regime. It mainly affects short-range devices, QR marking, test report submission and a specific category of implantable medical devices.
  • Potential benefit for manufacturers
    Manufacturers and importers may benefit from more flexible QR design rules and a clearer method for submitting confidential technical documentation.
  • Compliance review still required
    Companies should review QR label templates, technical files, test report submission workflows and product classification for devices operating in the 9–315 kHz range.

Who is affected?

  • Manufacturers of short-range devices.
  • Importers and distributors of RF devices in Chile.
  • Manufacturers of active implantable medical devices.
  • Medical device companies with low-power RF implantable products.
  • Regulatory affairs and product compliance teams.
  • Testing laboratories and certification bodies.
  • Labeling and packaging teams responsible for QR code implementation.
  • Local representatives managing SUBTEL submissions.

Conclusion

The update should be classified as medium impact. It is a confirmed regulatory change and may require action for companies dealing with short-range devices, QR code marking or active implantable medical devices. However, it does not create a broad new approval system or affect all telecom equipment categories. Its impact is concentrated on QR compliance flexibility, confidential test report handling and the inclusion of a specialized medical device category.

Regulatory Authority

Subsecretaría de Telecomunicaciones (SUBTEL), Ministerio de Transportes y Telecomunicaciones

Regulatory Impact

Impact TypeStatus
Top Priority
Type Certificate
Spectrum Bands
Import Changes (HS Codes)
Standard Changes
Product Changes
Label Changes

Chile Quick Facts

Regulatory AgencySubsecretaría de Telecomunicaciones (SUBTEL)
Certification TypeMandatory
License ValidityIndefinite
Application LanguageSpanish
Legal License HolderNot required
In-country Testing RequirementNo testing required

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