Health Canada citation
MDR s.45(h) - mandatory problem reporting
Health Canada inspection citation · Medical Devices Regulations (SOR/98-282)
Key facts
| Requirement | MDR s.45(h) - mandatory problem reporting |
|---|---|
| Regulation | Medical Devices Regulations (SOR/98-282) |
| Example observations (excerpt) | risk 2: the company did not have a written procedure in place for mandatory problem reporting. risk 2: the company did not have a written procedure in place for mandatory problem reporting, contrary to what was committed to on its establishment licence application. risk 2: the written procedure for… |
At a glance
- 100–999 Health Canada inspections citing this requirement
- Yes 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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