Hi,
A medical device contract manufacturer (CM) located outside US is responsible for finished device manufacturing but does not plan for distribution in US. The CM supplies to the OEM located in US. The OEM is responsible for distribution.
Does the CM need to register with FDA? Does the CM need to appoint a US agent? What are the product liability clauses applicable to CM?
Please help...
Thanks In advance
A medical device contract manufacturer (CM) located outside US is responsible for finished device manufacturing but does not plan for distribution in US. The CM supplies to the OEM located in US. The OEM is responsible for distribution.
Does the CM need to register with FDA? Does the CM need to appoint a US agent? What are the product liability clauses applicable to CM?
Please help...
Thanks In advance