Hello all,
So we're a contract manufacturer (non-US based) and will be manufacturing an unclassified medical device for a US based company. We have FDA medical device registration for class 1 but in order to add unclassified product, is there anything else i need to ensure regulatory requirements wise?
I understand i would probably need to ask my US agent to add the unclassified product to the med device registration. Is that it or is there more to ensure compliance?
My research for this question did not help me find answers. Please advise.
Regards
N
So we're a contract manufacturer (non-US based) and will be manufacturing an unclassified medical device for a US based company. We have FDA medical device registration for class 1 but in order to add unclassified product, is there anything else i need to ensure regulatory requirements wise?
I understand i would probably need to ask my US agent to add the unclassified product to the med device registration. Is that it or is there more to ensure compliance?
My research for this question did not help me find answers. Please advise.
Regards
N