Class B — Low-to-Moderate Risk Devices
Definition
Class B devices present a low-to-moderate risk and correspond broadly to EU MDR Class IIa. Typical examples include hypodermic needles, blood transfusion sets, short-term skin contact devices, and simple surgical instruments supplied sterile.
MDMA pathway
Class B devices require full MDMA via the TFA route with a more detailed technical file than Class A, and are subject to a deeper SFDA review.
Technical file requirements
In addition to the Class A elements, Class B devices require:
- Full risk management file (ISO 14971)
- Clinical evaluation report
- Detailed manufacturing process description
- Performance and safety testing data
- Post-market clinical follow-up plan (if applicable)
QMS requirements
Class B manufacturers must hold ISO 13485 certification from an SFDA-accredited CAB or IAF-accredited CB. SFDA may conduct manufacturing site audits.
Post-market for Class B
Class B devices require a Periodic Safety Update Report (PSUR) — more comprehensive than the Class A PMS Report. Class B PSURs must include risk-benefit conclusions, PMCF results, and sales volume data. PSURs must be updated at least every two years (or more frequently if triggered by new safety data).