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 (Medical Device National Registry listing) route. This route is no longer available as of September 2022. All devices must now follow the TFA (Technical File Assessment) 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
Further reading
On first mention of 'TFA route', add: 'All Class A devices (including As, Am, and Ar sub-types) require MDMA via the TFA route (Technical File Assessment) — the standard pathway for device registration with the SFDA.'