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How does Health Canada define “Manufacturer”?
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Health Canada defines a "Manufacturer" as: A person who sells a medical device under their own name, or under a trade-mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labeling, 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. (MDR P.C. 1998-783, 7 May 1998) |
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