MICS (Medical Implants) - SUBTEL Resolution 737 Compliance Chile

Regulatory category

Literal g of Resolution 1985

MICS (Medical Implant Communication Service) falls under literal g of Resolution 1985. It is the ONLY short-range equipment category that RETAINS the requirement of prior formal SUBTEL certification under Resolution 737. The MICS 402-405 MHz band is for exclusively medical use at very low power, typically to connect pacemakers, insulin pumps, neurostimulators, and cochlear implants with external devices.

Frequency bands authorized in Chile

Band	Range	Maximum power	Typical use
MICS 402-405 MHz	402 – 405 MHz	25 μW (-16 dBm)	Cardiac pacemakers, implantable cardioverter-defibrillators (ICD), insulin pumps, neurostimulators, cochlear implants, continuous glucose monitors with subcutaneous implant
2.4 GHz Medical	2.4 – 2.484 GHz	2.5 mW (4 dBm)	Wideband medical communication (short-range telemetry)

MICS 402-405 MHz: Extremely low power: 25 μW EIRP (equivalent to 0.025 mW). Maximum bandwidth 300 kHz. Must use interference reduction techniques per ITU-R RS.1346 Annex 1.

2.4 GHz Medical: Must use frequency hopping. Not to be confused with WiFi's 2.4 GHz band: here the regulatory limit and use are medical.

Source: SUBTEL Resolution 1985 EXENTA — official text on BCN. View Resolution 1985 on BCN

Regime under Resolution 737

Track 1 — Formal SUBTEL certification

MICS (Medical Implants) is one of the two categories (literals g and h) that Resolution 737 kept under the prior formal certification regime. Each device requires a certificate issued by SUBTEL before it can be marketed in Chile, in addition to ISP health registration when applicable.

View Resolution 737 on BCN

Edge cases and common compliance mistakes

MICS is the only case where Resolution 737 did NOT simplify the process: it retains prior formal certification before SUBTEL. Manufacturers expecting the QR self-declaration regime must plan ahead — the formal process takes weeks.

SUBTEL certification only covers radio-emission parameters. The medical device also requires health registration with the ISP (Instituto de Salud Pública), which is a separate process with its own timelines. Both run in parallel.

Medical equipment must additionally comply with IEC 60601 (medical electrical equipment) and with the EMC requirements of Resolution 3.103/2012. SUBTEL does not validate IEC 60601 — the manufacturer must present it separately.

No devices in our public catalog

MICS (Medical Implants) devices are uncommon in our public catalog because they still require Track 1 formal certification before SUBTEL under Resolution 737. If you need to process one, contact us: we manage the full process, from the test report to the SUBTEL submission.

Frequently asked questions about MICS (Medical Implants)

Do implantable medical devices require formal SUBTEL certification post-Resolution 737?

Yes. Resolution 737 explicitly reserved formal certification for literals g (MICS / medical implants) and h (other medical equipment). All other short-range devices moved to the QR self-declaration regime, but medical devices remain in Track 1: prior certificate issued by SUBTEL before they can be marketed in Chile.

What is the MICS band and why is it regulated separately?

The MICS (Medical Implant Communication Service) band occupies 402-405 MHz and is internationally reserved for communication with medical implants: pacemakers, insulin pumps, neurostimulators, ICDs. The reservation exists because implants operate at extremely low power (25 μW EIRP = 0.025 mW) and need a clean band free from WiFi, Bluetooth, and other commercial services. In Chile it is regulated under literal g of Resolution 1985.

Does SUBTEL validate the medical safety of the device?

No. SUBTEL certification only covers the device's radio-emission parameters: frequencies, power, modulation, electromagnetic interference. Clinical safety and medical-device health registration fall under the ISP (Instituto de Salud Pública de Chile), which is a separate process based on IEC 60601 and specific health regulation. Both processes must run in parallel.

What is the maximum power allowed in the MICS band?

25 μW EIRP (-16 dBm), equivalent to 0.025 mW. It is one of the most restrictive bands in the Chilean spectrum in terms of power, precisely because it is designed for ultra-low-power implantable devices that must last years on a single battery. Maximum bandwidth is 300 kHz and it must use interference reduction techniques per ITU-R RS.1346 Annex 1.

Can I import a pacemaker into Chile without SUBTEL certification?

No. Any implantable medical device that uses radio communication requires formal SUBTEL certification before it can be imported and sold in Chile. It additionally needs ISP health registration. Both processes are mandatory and there are no exceptions under Resolution 737 — the QR self-declaration regime applies only to literals a, b, c, d, e, f, i, j, k, not g or h.

MICS (Medical Implants) in Chile