Class C — Moderate-to-High Risk Devices
Definition
Class C devices present a moderate-to-high risk and correspond to EU MDR Class IIb. Examples include haemodialysis machines, ventilators, surgical lasers, spinal fixation devices (non-implantable), and phototherapy equipment.
MDMA pathway
Class C requires a comprehensive technical file with full clinical evaluation, detailed risk management, and performance testing data. SFDA review timelines are longer than for Class A/B, and SFDA may request additional information or clarifications during review.
QMS and inspections
For Class C, the SFDA may require an on-site inspection or audit of the manufacturer's QMS, in addition to CAB/IAF certification. Manufacturers should ensure their manufacturing facilities and quality systems are inspection-ready at all times.
Post-market for Class C
Class C devices require an annual PSUR — the most frequent update interval. The PSUR must include risk-benefit conclusions, PMCF results, sales volume, and any safety signals identified through PMS activities.