Search Results

Containing any of the words

Only of the type

(SG-2007-242-H) cases of structural valve deterioration insufficiency and early revision Medical Report

In case the products affected by the corrective action are related to specific serial numbers or lot numbers, Is KSA considered as not affected if the imported devices have different serial numbers or lot numbers? FAQ

Is it mandatory to submit the Field Safety Notice on the company’s account on NCMDR if it is received directly from SFDA via e-mail? FAQ

Should the manufacturer standardize the contents of the Field Safety Notice so it includes all the contents (Annex (B))? of the guidelines for corrective actions for safety warnings for medical devices and products? FAQ

How long does the manufacturer or the Authorized Representative (AR) must keep the records proving implementing the Field Safety Corrective Actions? FAQ

What is SFDA procedure if some users do not respond to the Authorized Representative (AR) or the supplier? regarding a Field Safety Corrective Action? FAQ

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