Prior to July 1, 1998, The "Medical Devices Regulations" of the Food and Drugs Act prohibited medical devices which were designed to generate airborne ozone to
which humans may be exposed. A limit of 0.05 ppm (vol/vol) was set
for other medical devices which generated ozone incidental to their
normal operation.
However,
when the new "Medical
Devices Regulations" came into effect on July
1, 1998, the old regulations and schedules ceased to exist and presently there
are no regulations on medical devices that produce ozone.*
To
replace the old Schedule VIII, the Therapeutic Products Programme
has drafted a policy on ozone generators. Meanwhile, the new "Medical Devices Regulations" establish general safety and effectiveness requirements for medical devices.
The policy describes the performance and quality standards in which
to measure the safety and effectiveness of subject devices. Health
Canada does not recognize any health benefits from human exposure
to ozone and therefore precludes approval of such devices under the "Medical Devices Regulations".
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