Health Canada citation
MDR s.61.4(1) - summary reports
Health Canada inspection citation · Medical Devices Regulations (SOR/98-282)
Key facts
| Requirement | MDR s.61.4(1) - summary reports |
|---|---|
| Regulation | Medical Devices Regulations (SOR/98-282) |
| Example observations (excerpt) | risk 2: the manufacturer did not prepare summary reports annually for class iii or iv devices. risk 2: the manufacturer did not prepare summary reports on a biennial basis for class ii devices. risk 2: the manufacturer did not prepare summary reports on a biennial basis for class ii devices. risk 2… |
At a glance
- 10–99 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
Browse all Health Canada regulation sections cited in inspections