Correct, pursuant to CMDR Section 44(2)(c), the "manufacturer" of a class II, III, or IV medical device who imports or sells the device in Canada is required to old a Medical Device Licence (MDL) but not a Medical Device Establishment Licence (MDEL) (notwithstanding other importation/sales activities in which the manufacturer might be involved that could separately trigger an MDEL obligation, such as importation/distribution of another manufacturer's medical devices, or such as class I device manufacturing).
The Section 44(2)(c) exemption from MDEL stands even if the manufacturer is also the importer of the subject device (but again, notwithstanding other activities in which the manufacturer may be engaged which could separately trigger an MDEL obligation). Health Canada's Medical Devices and Clinical Compliance Directorate clarified that for me during an inspection last year. They specifically pointed me to their MDEL guidance document which excludes manufacturers from the definition of "importer" even though the manufacturer might import the device themselves.
Remember also that if the class II, III, or IV device manufacturer works through a distributor(s) who import(s) and sell(s) the device in Canada, then each distributor who imports and sells the manufacturer's device in Canada is required to hold an MDEL except as follows: In Canada, "manufacturer" means a person who sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf. Accordingly, if the original manufacturer's device is private-labeled for a distributor who imports and sells the device in Canada under the distributor's own name, then the distributor becomes a private-label manufacturer and is thus, as a general rule, required to hold an MDL, not an MDEL.
Hope this helps.
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Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
ComplianceAcuity, Inc.
Golden, CO
United States
www.complianceacuity.com© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 19-Jan-2020 10:17
From: Anonymous Member
Subject: MDEL Health Canada
This message was posted by a user wishing to remain anonymous
Hi all,
Just for clarification, surrounding the MDEL vs. MDL for Device Licenses associated with Health Canada.
Question: If our organization manufactures Class III medical devices, sells to a distributor/customer and that distributor/customer imports into Canada and sells in Canada, is it correct to state that as the manufacturer we require an MDL, but not a MDEL? From the website it states. A MDEL is required for any person who imports into Canada or sells in Canada, a medical device (Class I-IV) for human use.