Search Results

Containing any of the words

Only of the type

If the Authorized Representative (AR) was unable to obtain a response to provide the corrective plan or ensure if the Kingdom is not affected within 5 working days, what is required and how is the response? FAQ

Who should fill out the risk evaluation form? The manufacturer or Authorized Representative (AR) and the importer? FAQ

Is it possible to provide risk assessment form from the manufacturer instead of the form mentioned in the Guidance on Medical Device Field Safety Corrective Actions? FAQ

What is the procedure if the medical device was supplied without telling the manufacturer? FAQ

What are the documents that SFDA has the right to request which support the closure process for Field Safety Corrective Actions? FAQ

If the corrective action includes destroying the affected devices, and the affected products were collected in the facility's warehouse, is it accepted to delay the destroying of the affected devices for some reasons (Some facilities destroy these products annually or semi-annually) FAQ

Are text messages, WhatsApp messages, or other programs considered as an acceptable way to inform users of Field Safety Notice FAQ

Is it possible to extend the period of informing the customers for more than 5 working days if we have large number of affected users? FAQ

What is the reference number meant in Statement Confirming Saudi Arabia is Not Affected form or Confirmation Statement for Completing the Field Safety Corrective Action form mentioned in the Guidance on Medical Device Field Safety Corrective Actions ? FAQ

If the Field Safety Notice was sent via e-mail, is receiving the e-mail sufficient for the notification? FAQ