NRN-523 Exam Questions and Answers

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NEW QUESTION: 1
A global company is developing a sophisticated implantable medical device that is coated with antibiotics
and biologics to enhance its efficacy. The product is marketed in Country X. where it is regulated as a
medical device. The same product, without the antibiotics and biologics, is marketed as a medical device
in Country Y. The company is proposing to start marketing the coated device in Country Y. Which
regulatory approach should the company propose?
A. Submit the product for review as a pharmaceutical product in Country Y.
B. Submit the product as a medical device in Country Y as the product is already marketed in Country X
as a medical device.
C. Examine decisions made about similar products in Country Y to propose the classification of the
product.
D. Apply for review of the additional part of the product as a pharmaceutical product in Country
Answer: D


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