Are Your Products Properly Labeled and Packaged?
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Questions and Answers

What is the requirement for language in the user manual for devices sold in Canada and the USA?

  • It must be written in both English and French
  • It must be written in French only
  • It must be written in the official language of the purchaser's jurisdiction
  • It must be written in English only (correct)

    • Under what circumstance will Swift Medical translate the materials to French?

  • If the materials are not available in French
  • If requested by a Canadian customer (correct)
  • If requested by a US customer
  • If the manufacturer is based in Quebec

    • What is the manufacturer's responsibility regarding directions for use in other jurisdictions?

  • To include them in the user manual
  • To make them available upon request of the purchaser (correct)
  • To provide them in both English and French
  • To ensure they are written in the official language of the purchaser's jurisdiction

    • What is the purpose of validating packaging integrity according to international shipping standards?

    <p>To ensure that the packaging materials maintain their integrity throughout shipping and storage</p> Signup and view all the answers

    What is the purpose of recording control numbers in the production report form?

    <p>To minimize labelling errors such as the application of incorrect control numbers to new product</p> Signup and view all the answers

    What is included in the validation of electronic labelling?

    <p>Ensuring the proper design and functioning of the instructions for use in electronic form</p> Signup and view all the answers

    What is the purpose of the designated Product Storage area at Swift Medical?

    <p>To ensure safe storage of inspected and accepted labels and packaging</p> Signup and view all the answers

    What is the purpose of the labeling procedure outlined in the text?

    <p>To minimize labelling errors for Swift Medical products</p> Signup and view all the answers

    What products does the labeling procedure apply to?

    <p>Both Swift Medical manufactured products authorized for sale in Canada and the USA, as well as investigational medical devices</p> Signup and view all the answers

    What is the main goal of providing warnings and cautions in the labeling procedure?

    <p>To minimize risk and potential hazards for customers using Swift Medical products</p> Signup and view all the answers

    What is the scope of the labeling procedure?

    <p>Labeling, packaging, and related Swift Medical processes of finished Swift Medical manufactured product authorized for sale in Canada and the USA</p> Signup and view all the answers

    What information must be included on the label of a medical device according to the text?

    <p>The device's intended purpose</p> Signup and view all the answers

    What additional information must be included on the label of an investigational testing drug in the United States according to the text?

    <p>A warning that it is limited by Federal law for investigational use</p> Signup and view all the answers

    What is the purpose of including the batch code on a medical device label according to the text?

    <p>To track and recall specific batches of the product</p> Signup and view all the answers

    What type of products may provide instructions for use in electronic form only according to the text?

    <p>Software products</p> Signup and view all the answers

    What is the purpose of stating the performance specifications of an investigational testing drug on the label according to the text?

    <p>To inform users that the drug's performance specifications have not been established</p> Signup and view all the answers

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