How Classification Works
The SFDA risk-based classification system for medical devices — how rules are applied, the role of MDS-REQ 1 and MDS-G008, and the four risk classes.
Class A — Low Risk
SFDA Class A medical devices — definition, sub-types (As, Am, Ar), documentation requirements, and registration pathway.
Class B — Low-to-Moderate Risk
SFDA Class B medical devices — definition, documentation requirements, QMS obligations, and PSUR frequency.
Class C — Moderate-to-High Risk
SFDA Class C medical devices — definition, documentation depth, SFDA audit exposure, and annual PSUR obligations.
Class D — High Risk
SFDA Class D medical devices — definition, maximum documentation and clinical evidence requirements, mandatory SFDA audit, and annual PSUR.
IVD Classification
SFDA risk-based classification for in vitro diagnostic (IVD) medical devices — classes and key criteria.
Software & SaMD Classification
How the SFDA classifies Software as a Medical Device (SaMD) — IMDRF principles, version management, and AI/ML considerations.
Borderline & Combination Products
SFDA approach to borderline products, combination devices, and products that span multiple regulatory sectors.
Classification Guidance — MDS-G008
The SFDA's MDS-G008 classification guidance document — how to use it, what it covers, and when to apply it for borderline and difficult classification cases.