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Medical device meetings draft guidance document: Appendices

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Device Advice: Meeting process map

This map outlines the steps for the Device Advice: Medical Device Meeting Program.

Figure 1: Device Advice: Meeting process map
Figure 1
Figure 1 - Text equivalent

Step 1: The Requestor sends a Meeting Request Form to Health Canada via email.

Step 2: Health Canada processes the form within 10 calendar days.

Step 3: Is the meeting accepted by Health Canada?

  • No: If the meeting is not accepted, Health Canada will send a Meeting Decision Letter to Requestor with written guidance; process ends here
  • Yes: If the meeting is accepted, process continues to step 4

Step 4: Health Canada sends a Meeting Decision Letter to requestor with meeting details.

Step 5: Requestor to provide meeting package, based on meeting type, to Health Canada 4 weeks prior to meeting date.

Step 6: If applicable, Health Canada will provide advanced feedback to requestor 1 week before meeting date.

Step 7: The meeting between Health Canada and requestor takes place.

Step 8: Requestor provides the meeting record of decisions (ROD) to Health Canada within 2 weeks of meeting date.

Step 9: Health Canada reviews and provides comments on the record of decisions to requestor within 2 weeks.

Step 10: Does requestor agree with comments from Health Canada on ROD?

  • Yes: Requestor to accept Health Canada comments on ROD within 1 week.
  • No: Requestor to communicate concerns regarding comments on ROD to Health Canada via email within 1 week. Any unresolved differences will be noted on the ROD by Health Canada.

Step 11: The record of decision is finalized.

Innovation information meeting record of decision template

Innovation Information Meeting – [DD-MM-YYYY]
Record of Decisions

Name of Manufacturer:

Name of Device:

Location:   

Time:

Participants

Health Canada Participants: (Name, Title, Bureau)

Manufacturer Participants: (Name, Title, Organization)

Other Participants: (Name, Title, Organization)

Record of Decisions

Presentation: Questions raised by Health Canada during the presentation and corresponding key points discussed (if applicable):

Action Items (if applicable):

Question 1 (from Innovation Information Meeting Package – if applicable):

Main points of Discussion/Summary of advice:

Action Items (if applicable):

Question 2 (from Innovation Information Meeting Package – if applicable):

Discussion/Summary of advice:

Action Items (if applicable):

Question 3 (from Innovation Information Meeting Package – if applicable):

Discussion/Summary of advice:

Action Items (if applicable):

Note: Duplicate the table above as necessary for additional questions.

Pre-clinical meeting record of decision template

Pre-Clinical Meeting – [DD-MM-YYYY]
Record of Decisions

Name of Manufacturer:

Name of Device:

Location:   

Time:

Participants

Health Canada Participants: (Name, Title, Bureau)

Manufacturer Participants: (Name, Title, Organization)

Other Participants: (Name, Title, Organization)

Record of Decisions

Presentation: Questions raised by Health Canada during the presentation and corresponding key points discussed (if applicable):

Action Items (if applicable):

Question 1 (from Pre-Clinical information package):

Main points of Discussion/Summary of advice:

Action Items (if applicable):

Question 2 (from Pre-Clinical information package):

Discussion/Summary of advice:

Action Items (if applicable):

Question 3 (from Pre-Clinical information package):

Discussion/Summary of advice:

Action Items (if applicable):

Note: Duplicate the table above as necessary for additional questions.

Pre-submission meeting record of decision template

Pre-Submission Meeting – [DD-MM-YYYY]
Record of Decisions

Name of Manufacturer:

Name of Device:

Location:   

Time:

Participants

Health Canada Participants: (Name, Title, Bureau)

Manufacturer Participants: (Name, Title, Organization)

Other Participants: (Name, Title, Organization)

Record of Decisions

Presentation: Questions raised by Health Canada during the presentation and corresponding key points discussed (if applicable):

Action Items (if applicable):

Question 1 (from Pre-Submission information package):

Main points of Discussion/Summary of advice:

Action Items (if applicable):

Question 2 (from Pre-Submission information package):

Discussion/Summary of advice:

Action Items (if applicable):

Question 3 (from Pre-Submission information package):

Discussion/Summary of advice:

Action Items (if applicable):

Note: Duplicate the table above as necessary for additional questions.

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