Health Canada Begins Ranking Inspections According to Risk

Observations made during device facility inspections in Canada are now being ranked according to risk, a final Health Canada guidance says.

The new approach, which went into effect this month, applies to regular, follow-up and targeted inspections. It is intended to ensure uniformity among Health Canada inspectors and advise devicemakers on deviations the agency considers unacceptable.

Following an inspection, devicemakers will be given an overall compliance rating based on the number of observations and risks involved, the guidance says.
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