On 27 May 2026, Chile published Resolución 966 EXENTA, which introduces amendments to the existing technical standards for Short Range Devices (SRD) originally established under Resolution 1.985. These changes are designed to modernize certification processes and accommodate emerging radio technologies within the Chilean market.
The regulatory update introduces several key changes that manufacturers should be aware of:
- New Medical Device Category: Specific provisions have been added for extremely low power active implantable medical devices. These devices are now permitted to operate in the 9-315 kHz frequency range with defined field strength limits.
- Flexible Labeling Requirements: The mandatory QR code labeling requirements have been relaxed. Manufacturers now have greater autonomy over the size and design of the QR code, moving away from rigid formatting as long as the code remains functional and readable.
- Streamlined Documentation: The procedure for submitting confidential technical evidence to SUBTEL has been updated, allowing for electronic submissions via the Virtual Filing Office and designated institutional mailboxes.
These amendments aim to reduce administrative barriers and facilitate easier market entry for manufacturers, particularly those in the medical technology sector. Manufacturers are encouraged to review their current labeling designs and technical documentation processes to ensure alignment with these new provisions.