Health Canada - Device Changes to include in License Renewal

tehuff

Involved In Discussions
#1
Hi - has anyone received feedback from Health Canada about the types of device changes that should be reported in the annual license renewal? There are no guidances for this. Thanks!
 
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yana prus

#3
Hi,
According to Guidance Document - Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices, http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/md_licren_mm_homren-eng.php
Changes not accepted on the Renewal Form.

Changes to information other than changes to the contact information and notification of discontinuance must be made by submitting the appropriate amendment forms listed below and available on the Health Canada website:

Medical Devices Licence Amendment Fax-Back Form - Guidance for Non-Significant Additions/Deletions (non-significant changes to catalogue numbers);
Medical Devices Licence Amendment Fax-Back Form - Guidance for Changes to Manufacturer's Name and/or Address of Existing Device Licences;
Licence Amendment Fax-Back Form - Guidance for Changes to the Name of a Device for Existing Device Licences;
Class II Medical Device Licence Amendment Application Form;
Class III Medical Device Licence Amendment Application Form;
Class IV Medical Device Licence Amendment Application Form.
 

tehuff

Involved In Discussions
#4
I contacted the Medical Devices Bureau of Health Canada to clarify and this is the response:
"Non-significant administrative changes should be reported by amendment or faxback. Other changes can be reported as a notification during renewal and the regulatory requirement can be found in section 43(1)(b) of the Medical Devices Regulations ( http://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/index.html)."
 
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