Health Canada citation
MDR s.61.4 (1)(a) preparation of summary reports for class ii medical devices
Health Canada inspection citation · Medical Devices Regulations (SOR/98-282)
Key facts
| Requirement | MDR s.61.4 (1)(a) preparation of summary reports for class ii medical devices |
|---|---|
| Regulation | Medical Devices Regulations (SOR/98-282) |
| Example observations (excerpt) | risk 2: the manufacturer did not prepare summary reports on a biennial basis for one or several class ii medical devices. the manufacturer did not prepare summary reports for one or more devices. |
At a glance
- 1–9 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