Class A — Low Risk Devices
Definition
Class A devices present the lowest level of risk to patients and users. Under the SFDA framework, Class A broadly corresponds to EU MDR Class I devices. Classification follows the rules in MDS-REQ 1.
Typical Class A devices include non-sterile, non-measuring consumables and instruments: cotton wool, non-sterile examination gloves, stethoscopes, tongue depressors, and non-powered wheelchairs.
Class A sub-types
Despite being Class A overall, three sub-categories carry heightened requirements:
| Sub-type | Meaning | Additional requirement |
|---|---|---|
| Class As | Supplied in a sterile condition | Annex II/III conformity assessment; sterility must be maintained |
| Class Am | Incorporates a measuring function (e.g. calibrated thermometer, graduated syringe) | Metrological aspects must be verified |
| Class Ar | Reusable surgical instruments intended to be re-sterilised by healthcare facilities | Validation of cleaning/sterilisation instructions |
MDMA pathway for Class A
All Class A devices (including As, Am, and Ar sub-types) require MDMA via the TFA route. There is no longer a simple self-declaration or listing pathway — the MDNR (Medical Device National Registry) was cancelled in September 2022.
Before September 2022, basic Class A non-sterile, non-measuring devices could be registered via the simplified MDNR (listing) route. This route is no longer available. All devices must now follow the TFA pathway.
Technical file requirements for Class A
Standard Class A devices require an abbreviated technical file compared to higher classes. Key elements include:
- Device description and intended use
- Labelling and IFU
- Proof of QMS certification (ISO 13485)
- Declaration of Conformity (Annex 14 of MDS-REQ 1)
- Risk management summary
- Reference country approval evidence (if available)
Class As, Am, and Ar devices require more detailed technical documentation aligned with the specific conformity assessment route.
QMS for Class A
Class A manufacturers must hold a QMS certified by an SFDA-accredited CAB or IAF-accredited CB. SFDA inspection of manufacturing sites is less common for Class A but remains an SFDA option.
Post-market for Class A
Class A manufacturers must maintain a PMS Report (rather than the full PSUR required for Class B–D). The PMS Report must:
- Summarise PMS data collected
- Document findings and conclusions
- Record any CAPAs taken
- Be updated as needed and available on SFDA request