In case the manufacture sells medical devices directly to customers without an Authorized Representative (AR), who is responsible for informing the affected customers and providing the corrective action plan and closure?
Question
In case the manufacture sells medical devices directly to customers without an Authorized Representative (AR), who is responsible for informing the affected customers and providing the corrective action plan and closure?
Answer
The manufacturer is responsible for the medical devices marketed in the KSA, as well as the supplier and distributor.
