Summary of Resolución 966 EXENTA (Chile)
Scope and Impact
Published in May 2026, Resolución 966 EXENTA modifies the technical standards for Short Range Devices (Equipos de Alcance Reducido) in Chile. The regulation aims to modernize certification procedures by facilitating the use of QR codes for labeling, streamlining the submission of confidential technical documentation, and incorporating specific provisions for active implantable medical devices.
Permitted Radio Bands and Technical Parameters
The regulation introduces a new category for medical devices with the following technical specifications:
Designated Use: Active implantable medical devices of extremely low power.
Frequency Range: 9 - 315 kHz.
Maximum Field Strength: 30 dBµA/m (or its equivalent in dBµV/m) measured at a distance of 10 meters.
Conformity Assessment and Testing Procedures
The regulation updates the procedures for submitting technical evidence to the Undersecretary of Telecommunications (SUBTEL):
Test Report Submission: As an alternative to public filing, confidential versions of Test Reports may now be submitted through SUBTEL’s Virtual Filing Office (Oficina de Partes Virtual).
Electronic Delivery: Documentation can also be sent via email to the designated institutional mailbox. Submissions must include the specific Entry Number (Número de Ingreso) and relevant equipment identification references to ensure correct processing.
Labeling Requirements
The requirements for the mandatory QR code labeling have been made more flexible to accommodate diverse device designs:
Size: The dimensions of the QR code may be freely determined by the responsible party, provided that the code remains readable and functional.
Standards: It is recommended, though not strictly mandatory, that the QR code complies with the ISO/IEC 18004 standard.
Design: Previous restrictions requiring specific "squared" formats have been replaced with a "free choice" of design, allowing manufacturers to adapt the label to the device's aesthetics while ensuring it meets minimum readability conditions.
Modifications to Existing Regulations
This regulation directly modifies Resolución No. 1.985 Exenta de 2017, de la Subsecretaría de Telecomunicaciones, que fija Norma Técnica de Equipos de Alcance Reducido. The amendments specifically target Article 1 (adding new device categories) and Article 2 (updating administrative procedures for test reports and labeling specifications).
