Skip to main content

Telemedicine & Connected Devices

Overview​

Telemedicine has grown significantly in Indonesia, particularly following the COVID-19 pandemic, which accelerated digital health adoption. The regulatory landscape for telemedicine and connected medical devices in Indonesia sits at the intersection of:

  • Medical device regulation (Kemenkes / Regalkes)
  • Telemedicine service regulation (Ministry of Health telemedicine regulations)
  • Telecommunications regulation (Ministry of Communications and Information Technology — Kominfo)
  • Personal Data Protection Law

What Is a Connected Medical Device?​

A connected medical device is a hardware medical device that transmits data electronically — either to a healthcare provider, a companion app, a cloud platform, or another device. Examples:

  • Remote patient monitoring devices (blood glucose meters with connectivity, home ECG monitors, continuous glucose monitors)
  • Connected pulse oximeters and blood pressure monitors
  • Smart inhalers
  • Implantable devices with remote telemetry capability
  • Wearable biosensors for clinical use

Device Registration Requirements​

The hardware connected medical device requires a standard NIE registration through Regalkes, classified by its risk class under the general ASEAN classification rules. Connectivity features do not change the fundamental classification — the device is classified based on its primary medical function.

However, the connected aspects of the device do add additional documentation requirements:

  • Cybersecurity risk assessment (how could the wireless/network connectivity be exploited to harm patients or compromise data?)
  • Data integrity measures
  • Description of the companion app/software, if any (is it a medical device in its own right — SaMD?)
  • Cloud data storage architecture and data residency

Telemedicine Service Regulation​

Telemedicine platforms (video consultation, e-prescription, remote diagnosis services) are regulated separately from medical devices under:

  • Permenkes No. 20/2019 on telemedicine services (and subsequent updates)
  • Telemedicine services must be operated by licensed healthcare facilities
  • Physicians providing telemedicine services must hold valid Indonesian medical licences

If a medical device is specifically designed to enable or support a telemedicine service (e.g. a remote stethoscope, a telepathology imaging system), it may face dual regulatory scrutiny — both as a medical device (NIE from Kemenkes) and as part of a telemedicine service setup.

Personal Data Protection (UU PDP)​

The Personal Data Protection Law (Law No. 27 of 2022) came into force in 2024 and sets requirements for the processing of personal data — including health data generated by connected devices. Key obligations for connected device manufacturers:

  • Lawful basis for data collection (patient consent)
  • Data minimisation
  • Security measures for health data
  • Breach notification
  • Data subject rights (access, correction, deletion)
  • Restrictions on cross-border data transfer

Manufacturers of connected devices that process Indonesian patient data must assess UU PDP compliance alongside the device registration process.