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Karen Zhou, RAC, JD

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Canada

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1 to 5 of 50+ total

RE: Health Canada - A non-significant/Administrative Class III Amendment Submission

Posted By Karen Zhou 26-Apr-2023 09:18
Found In Egroup: Regulatory Open Forum \ view thread
Hello Sravan There is no guidance on Administrative Amendment. Usually, this is submitted for multiple changes or changes that cannot be submitted through a fax-back. Faxback is pretty limited. Follow the folder structure (ToC structure for Class II, III, IV). It's the same format for regular amendments. ...

RE: Registering Non Sterile Reusable Device in Canada

Posted By Karen Zhou 25-Apr-2023 13:12
Found In Egroup: Regulatory Open Forum \ view thread
Hello Anon, I came across this document. I hope it helps.  https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-information-manufacturers-sterilization-reusable-medical-devices.html ------------------------------ ...

RE: Canadian MDL - discontinuation

Posted By Karen Zhou 18-Oct-2022 09:44
Found In Egroup: Regulatory Open Forum \ view thread
Here is the provision in the CMDR:  43(3) If the holder of a medical device licence discontinues the sale of the medical device in Canada, the licensee shall inform the Minister within 30 days after the discontinuance, and the licence shall be cancelled at the time that the Minister is informed. Upon ...

RE: MDL application to CA

Posted By Karen Zhou 20-Sep-2022 07:05
Found In Egroup: Regulatory Open Forum \ view thread
Hello, For these MDL submissions, it depends on the size of your application.  I believe 20 MB is the cut-off for sending by email. More than that, you will require sending by mail with your submission on a USB stuck or burned on a CD.    ------------------------------ Karen Zhou ----------- ...

RE: ISO 13485

Posted By Karen Zhou 07-Sep-2022 05:13
Found In Egroup: Regulatory Open Forum \ view thread
Hello Anon In my experience, which type of certification to go for depends on the person's role within the organization. There is no prerequisite to the Lead Auditor certification (e.g., you do not need the internal auditor certification first before the lead auditor certification). ------------ ...