A marketing company has arranged to manufacture a class II medical device in a foreign country that will be sold in the USA. The supplier of the medical device will label the medical device with the marketing company's name. The marketing company will provide customer support and handle recalls, and complaints.
The supplier is already registered with the FDA.
Does the marketing company need to get establishment registration with the FDA?
Does the marketing company need to comply with 21CFR820 and if yes, why?
Thanks for your help.
Danny
The supplier is already registered with the FDA.
Does the marketing company need to get establishment registration with the FDA?
Does the marketing company need to comply with 21CFR820 and if yes, why?
Thanks for your help.
Danny