Health Canada citation
MDR s.45 (h.1) incident reporting and/or provision of information in respect of serious…
Health Canada inspection citation · Medical Devices Regulations (SOR/98-282)
Key facts
| Requirement | MDR s.45 (h.1) incident reporting and/or provision of information in respect of serious risk of injury to human health |
|---|---|
| Regulation | Medical Devices Regulations (SOR/98-282) |
| Example observations (excerpt) | deficiencies were noted in the procedure for incident reporting. deficiencies were noted in the procedure for the provision of information related to serious risk of injury to human health. deficiencies were noted in the written procedures. no written procedures were provided one or more procedures… |
At a glance
- 100–999 Health Canada inspections citing this requirement
- No Among the 20 most-cited Health Canada requirements
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Health Canada regulation sections cited in inspections
Health Canada inspection reports cite the section of the Food and Drug Regulations, Medical Devices Regulations or Blood Regulations behind each observation. This page counts the published inspections that cite the requirement.
Source: Health Canada, Drug and Health Product Inspections; citation counts by Orca1. Contains information licensed under the Open Government Licence – Canada
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