Medical Devices Regulations (SOR/98-282)

UNDER THE Medical Devices Regulations

I, , certify that I have knowledge of all matters contained in this certificate and that

• 1 I am (check applicable box)

  • (a) where the medical device described in this certificate is exported by a corporation

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      the exporter’s senior executive officer,
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      the exporter’s senior regulatory officer,
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      the authorized agent of the exporter’s senior executive officer, or
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      the authorized agent of the exporter’s senior regulatory officer; and

  • (b) where the medical device described in this certificate is exported by an individual

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      the exporter, or
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      the exporter’s authorized agent.

  

  , (State name and address of exporter or, if a corporation, name and address of principal place of business in Canada).

• 2 On the day of , , a package containing (description of device, including serial number, model name, lot number and quantity, as applicable; if additional space required, attach as Appendix “A”) is/will be consigned to (name and address of consignee).

• 3 The package is marked in distinct overprinting with the word “Export” or “Exportation”.

• 4 The medical device was not manufactured for consumption in Canada.

• 5 The medical device is not sold for consumption in Canada.

• 6 The package and its contents do not contravene any known requirement of the law of the country of (state country of consignee).

• 7 All relevant information is contained in this certificate and no relevant information has been knowingly withheld.

Signature

Position title

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Date