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Listening Quiz: Hồ Sơ Nộp Cơ Quan Quản Lý Cho Sản Phẩm Dệt May Y Tế – Advanced Level
Th3 4, 2025
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bởi
Anna Phạm
trong
Tiếng Anh dành cho Kỹ sư dệt may (English for Textile Engineer)
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1.
What are Sarah and Kevin mainly discussing?
Preparing a regulatory submission for a medical textile product
Planning a marketing campaign for a new product
Negotiating a contract with a supplier
Training staff on workplace safety procedures
Explanation:
The conversation is about finalizing and submitting regulatory documents for a medical textile product.
2.
What type of product class does Sarah believe the item fits under?
Class III surgical equipment
Class II medical textiles
Class IV laboratory supplies
Class I medical devices
Explanation:
Sarah says, “I believe it fits under Class II medical textiles.”
3.
What does Sarah say is required for the submission instead of clinical data?
Patent documents and financial statements
Customer surveys and sales data
Installation manuals and warranty forms
Only bench testing and biocompatibility reports
Explanation:
Sarah says no clinical data is needed, and that only bench testing and biocompatibility reports are required.
4.
What can be inferred about the status of the technical file?
It only contains test reports and nothing else
It is being prepared but is not yet finished
It was rejected because it lacked labeling information
It has already been submitted to the regulatory body
Explanation:
Sarah says, “I am working on it,” which shows the technical file is still being prepared and not yet finished.
5.
When does Sarah plan to complete the final review?
After the submission is approved
By the end of the week
By tomorrow morning
By this afternoon
Explanation:
Sarah says, “I plan to complete it by this afternoon.”
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