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Hi Christoph, Thank you so much for your advice! We have obtained CE marking under MDD and our MDR "conversion" application has been under review for almost two years during which a lot of non-significant changes have been made mainly by our suppliers. While in the US, these are either 30-day notice ...

This is very helpful, deeply appreciate it, Kevin! ------------------------------ Jo Huang RAC Dir, Regulatory Affairs San Diego, CA ------------------------------

Dear Colleagues, It has been very challenging to deal with our NB since we submitted our MDR for class 3, AIMD. While under MDR review, NB has been asking that we submit every and all changes, regardless of significance made to the product. We've been receiving micro review requests on non-significant ...

Thank you so much, Grace, for adding more context! Deeply appreciate it :) ------------------------------ Jo Huang RAC Assoc Manager - Regulatory Affairs Irvine CA United States ------------------------------

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 ...