SaMD Overview
Indonesia's regulatory approach to Software as a Medical Device (SaMD) — current classification principles, GHTF/IMDRF alignment, and the evolving guidance landscape.
IVD Digital Platforms
Regulatory considerations for AI/ML-driven IVD platforms, laboratory information systems (LIS), and molecular diagnostic software in the Indonesian regulatory framework.
Telemedicine & Connected Devices
Regulatory considerations for remote patient monitoring devices, connected wearables, and telemedicine platforms in Indonesia — the intersection of device regulation and telemedicine law.