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The FDA approves new human drugs and biological products. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards.
The Canadian Food Inspection Agency (CFIA) will instead issue the Certificate of Free Sale (CFIA/ACIA 5786) when a certificate or commercial document is required for export.
FDAs export certification provides the agencys official attestation concerning a products regulatory or marketing status, based on available information at the time FDA issues the certificate (including, as appropriate, attestations provided by the person seeking the certificate).
An export certificate is a type of official assurance, providing an importing country with confirmation from the Canadian government in this case, the Canadian Food Inspection Agency (CFIA) that your product or commodity meets certain standards and requirements. Not all countries or all products require them.
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nations ability to prepare for and respond to public health emergencies.
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Complete the following 4 steps to get a Safe Food for Canadians licence (SFC licence). Step 1: create an account in My CFIA. Step 2: determine your licence structure. Step 3: complete the licence application. Step 4: receive your licence.
FDA approval is usually mandatory to market or sell products in the US that might have a docHub risk of injury or illness, but can also benefit your health -- such as prescription medications, over-the-counter medications, vaccines and Class III medical devices.
To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use.

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