Medical IoT device certification by Kominfo/Komdigi is a critical requirement for manufacturers, importers, and distributors planning to market IoT-based medical devices in Indonesia. These devices combine healthcare functions with wireless communication technologies, making regulatory compliance essential.
Without proper certification, medical IoT devices may face import restrictions, distribution bans, or rejection for clinical use.
What Is Medical IoT Device Certification?
Medical IoT device certification is a technical evaluation process to ensure compliance with Indonesian telecommunication regulations, lawful radio frequency usage, and device safety.
The certification is issued by SDPPI (Postel) under the Ministry of Communication and Digital Affairs (Kominfo/Komdigi), covering wireless technologies such as Wi-Fi, Bluetooth, LTE, NB-IoT, and LoRa.
Medical IoT Devices Requiring Certification
Examples include:
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Smart medical wearables (heart rate, oxygen, blood pressure monitors)
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Remote patient monitoring devices
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Medical equipment with Wi-Fi or Bluetooth connectivity
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Telemedicine IoT systems
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Diagnostic devices with wireless communication modules
In addition to telecommunication certification, medical devices generally require approval from the Ministry of Health.
Medical IoT Device Certification Requirements
Typical requirements include:
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RF test reports from accredited laboratories
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Compliance with approved frequency bands
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Technical documentation (datasheets, block diagrams, user manuals)
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Company legal documents (business registration)
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Supporting documents based on wireless technology
Each embedded communication module must comply with Indonesian regulations.
Importance of Medical IoT Device Certification
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Telecommunication Regulatory Compliance
Ensures lawful spectrum usage. -
Device Safety and Reliability
Guarantees stable and interference-free operation. -
Smooth Import and Market Approval
Supports customs clearance and medical distribution permits. -
Healthcare Market Trust
Certified devices gain trust from hospitals and healthcare providers.
Conclusion Biruni Consulting
Medical IoT device certification is essential for compliant and legal deployment of connected medical devices in Indonesia.
Biruni Consulting provides end-to-end medical IoT device certification services, including regulatory assessment, RF testing coordination, and SDPPI/Postel certification assistance, ensuring a smooth, compliant, and efficient certification process.
