Guidance on safety and performance specifications for filtering facepiece respirators (FFRs) during COVID-19: Appendix B, checklist for interim order submission

Find information on the requirements for getting medical devices authorized in Canada on the medical devices page.

#	Item	Check
1	engineering drawings	N/A
2	materials specifications	N/A
3	intended use	N/A
4	biocompatibility test results	N/A
5	particulate filter efficiency	N/A
6	airflow resistance	N/A
7	fit testing	N/A
8	mechanical headstrap strength testing	N/A
9	elastomeric respirator-specific PFE and breathability testing (if applicable)	N/A
10	cleaning and disinfection (if applicable)	N/A
11	filter reuse conditions (if applicable)	N/A
12	flammability (if applicable)	N/A
13	fluid resistance (if applicable)	N/A
14	other testing (if applicable) for any additional labelling claims	N/A
15	shelf life/expiration date validation and/or plan	N/A
16	mask labelling representation (as directed in tables 3 and 4)	N/A
17	packaging labelling (all information to be marked on packages or provided to the user)	N/A
18	quality management arrangements: manufacturing process flow chart	N/A
19	manufacturing process outline	N/A
20	sampling plan and acceptance criteria	N/A
21	quality control records plan	N/A

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2024-01-03