Q8
Multiple choice
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 theantibiotics 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?
Select all that apply.