1. Medical Devices Program Performance Report
Second Quarter (Q2)
Fiscal Year
Therapeutic Products Directorate
Health Products and Food Branch
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

2. Outline Licences and Authorizations
Screening Time against 15 Day Target
Volume of Screening Deficiencies
Time To First Decision
Volume of Additional Information Requests
Time For Second Decisions
Market Authorization Time
Publication Impact on SDL and AI Trends
HPFBI Stats
MHPD Stats 1
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

3. Licences 2
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

4. Licences 3
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

5. Licences 4
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

6. Licences 5
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

7. Licences 6
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

8. Authorizations 7
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

9. Authorizations 8
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

10. Screening Time Against 15 Day Target9
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

11. Volume of Screening Deficiencies10
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

12. Volume of Screening Deficiencies11
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

13. Volume of Screening Deficiencies12
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

14. Volume of Screening Deficiencies13
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

15. Time To First Decision 14
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

16. Volume of Additional Information Requests15
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

17. Volume of Additional Information Requests
MEDEC CRITICAL 16
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

18. Volume of Additional Information Requests17
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

19. Volume of Additional Information Requests18
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

20. Time For Second Decisions (Average AI Review Time)19
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

21. Market Authorization Time20
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

22. Market Authorization Time21
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION

23. Inspectorate – Statistics

24. Inspectorate – Statistics

25. Inspectorate – Statistics

26. Inspectorate – Statistics

27. Inspectorate – Statistics

28. Inspectorate – Statistics

29. MHPD – Statistics

30. MDB_Enquiries@hc-sc.gc.ca 22
DRAFT DATA ONLY - NOT FOR DISTRIBUTION OR PUBLICATION