RAC-US Exam Dumps | A global company is developing a sophisticated implantable medical device that is coated with antibiotics

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RAPS.RAC-US.v2022-06-11.q34
Question 16

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Question 16/34

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. Examine decisions made about similar products in Country Y to propose the classification of the product.

B. Apply for review of the additional part of the product as a pharmaceutical product in Country

C. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.

D. Submit the product for review as a pharmaceutical product in Country Y.

Correct Answer: B

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