Hi there. Wonder if you can elaborate on the "importer of record" citation? I assume you are based outside of Canada and have an importer based in Canada? That importer needs a MDEL to operate in compliance with Canadian MDRs. Assume for the purposes of ISO 13485 / MDSAP you would consider them as a distributor but would appreciate a little more context to see if I can help.
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Don Boyer BSc, RAC, FRAPS
President
BOYER@RegulatorySolns
Ottawa ON
Canada
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Original Message:
Sent: 26-Apr-2021 17:52
From: Anonymous Member
Subject: Health Canada/MDSAP Requirement: Importer of Record
This message was posted by a user wishing to remain anonymous
Hi all,
As a medical device manufacturer, Class III device (in Health Canada), I am having difficulty understanding the requirements as it relates to the "Importer of Record". I understand they need to be listed as a supplier however, would this be a distributor/customer or a customs broker? I need a little clarification. How does anyone else list their importer of record and maintain it as a supplier?