Dear colleagues,
I came across an article that some Chinese manufacturers aim to submit their MD in countries that recognize NMPA marketing approval. I don't recall any country that accepts NMPA approval as a predicate approval. Please educate me on this :)
My other question is regarding CE marking recognition outside of the EU - what are the countries that 1) require a predicate approval, AND 2) accept CE Mark as that predicate approval?
I deeply appreciate your valuable insights into this topic.
Thanks,
Jo
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Jo Huang RAC
Assoc Manager - Regulatory Affairs
Irvine CA
United States
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