Pulse oximeters, glucometers at grocery stores? Centre plans rule change
The proposal covers Class A devices, which are considered low-risk products such as absorbent cotton, surgical dressings, bandages and digital thermometers, as well as select Class B devices, which carry low-to-moderate risk, including digital blood pressure monitors, pulse oximeters, glucometers and rapid urine pregnancy test kits. Higher-risk Class C and D devices, including ventilators, dialysis machines, orthopaedic implants and infusion pumps, will continue to be subject to licensing and other regulatory requirements.