Hi Anon,
So HC has changed the way they process applications and this "intent to reject" is not actually in the guidance document for the management of applications. This "intent to reject" is to give an opportunity to the manufacturer to respond to the issues that are outlined in the letter in an attempt to possibly change HC's mind and reconsidered. This is equivalent to Level 1 - Opportunity to be Heard: Reconsideration as described in Section 2.14 Opportunity to be Heard Process in the guidance document.
Hope this helps,
Shirley
Shirley Furesz, Ph.D., RAC
Amerisource Bergen
TPIreg, Innomar Strategies
Director Regulatory Affairs, Medical Devices
Cell phone: 519-242-6476
Fax: 888-887-8686
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Oakville ON L6L0C4
Canada
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Original Message:
Sent: 9/30/2022 4:50:00 PM
From: Anonymous Member
Subject: Health Canada: Notice of Intent to Reject
This message was posted by a user wishing to remain anonymous
Hello
In the eyes of Health Canada, is a 'RE: Notice of Intent to Reject' the same as a 'RE: Rejection Letter' as per section 2.14.1 of: Guidance Document: Management of Applications for Medical Device Licences?