Digital Health & SaMD

Regulation of software, Software as a Medical Device (SaMD), AI/ML devices, and cybersecurity requirements in Vietnam.

📄️Software & SaMD Overview

How Vietnam regulates Software as a Medical Device (SaMD) — DAV's approach, classification, and key obligations under Decree 98/2021.

Regulatory considerations for artificial intelligence and machine learning medical devices in Vietnam.

Cybersecurity requirements and expectations for networked and connected medical devices in Vietnam.