What Malaysia Medical Device Authority (MDA) SaMD & Digital Health Framework 2026 requires
MDA aligns SaMD classification with IMDRF while requiring local registration and cybersecurity testing. 2026 guidance introduces fast-track for AI-enabled devices with reference approvals from FDA, CE, or HSA.
Pillar: Medical & Healthcare · Authority: Medical Device Authority Malaysia · Version: 1.0.0 · Last updated:
Primary source: https://www.mda.gov.my/
SHA-256 integrity: 8d14074e74ce0daee7245a9ed765e49a16f3f19c4ce1c71688fa15f2e2ffdd8d
Primary Citations — 5 traced to source
- Medical Device Authority (MDA) Malaysia, Guidelines on Software as a Medical Device (SaMD) 2021
- International Medical Device Regulators Forum (IMDRF) SaMD Guidance Document 2019
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/malaysia-mda-samd-2026.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/malaysia-mda-samd-2026.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/malaysia-mda-samd-2026
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