It depends; we will need more details in order to answer definitively. But here are some general rules:
- If Company B is a contract manufacturer of a device where such device is identified on Company A's medical device license with Company A acting and identified on the label as the responsible manufacturer (though not the contract manufacturer/fabricator) and Company A's MDSAP QMS controls the design, manufacture, assembly, processing, labeling, packaging, etc., of the Company B device, then Company A can sell that device under the medical device license held by Company A.
- But if Company B makes a medical device independent of Company A (e.g., Company B is not operating under Company A's MDSAP QMS; Company B's device is a different device, etc.) even if Company B's device is like, or the same as, Company A's device yet is not Company A's device [e.g., because the Company B device is not designed, manufactured, assembled, processes, labeled, packaged, etc., under Company A's direct (i.e., MDSAP) control], then Company A cannot sell such a device under Company A's device license. Instead, Company B would need its own device license for such sale (e.g., for Company A to be a distributor, for Company B to sell it, etc.).
- There could be other permutations (such as those related to private labeling) depending on the specifics of your case, and such specifics need to be known in more detail in order to give more definitive direction.
Ultimately, these general rules are governed by Health Canada's regulatory provision establishing that medical device licensing requirements apply to the "manufacturer" of Canadian class II, III, and IV devices. Essentially, the "manufacturer" is the one so named on the label. This is based on Health Canada's CMDR definition: 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.
In practical terms, the "manufacturer" definition isn't clearly contingent on matters of corporate legal ownership. Instead, a bottom line is that it is governed by practical and operational intents and purposes, such as by who is the MDSAP QMS operator and certificate holder; who is the MDSAP design/development file owner/holder/controller; etc.
Nor is the "manufacturer" obligation contingent on who actually makes/fabricates the device. Instead, in practical terms, it is governed by who is responsible and in MDSAP control and so named on the label.
Finally, note also that Health Canada's CMDR requirements don't include the notion of "registering" products. Instead, the official concepts are "Medical Device Licensing" (along with associated MDSAP QMS registration/certification) and/or "Medical Device Establishment Licensing".
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Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 11-Mar-2024 15:33
From: Nicole Thibodeau
Subject: Health Canada
Hello,
If Company A has a Medical Device License in Canada and wants to sell a product manufactured by Company B (which is owned by Company A), can Company A register Company B's products in Company A's name?
Thank you!
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Nicole Thibodeau
Regulatory Affairs Specialist II
Hamilton Thorne Inc.
Beverly MA
United States
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