Medical Devices

Question

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


Answer

The manufacturer should fill out the risk assessment form


Question

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?


Answer

 Authorized Representative (AR) should respond to SFDA with any remarks and justifications within the specified period.


Question

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


Answer

If users are not responding to the Authorized Representative (AR) or the supplier in regards to implementing the corrective or preventive action and evidence is provided, the necessary actions will be taken to ensure safe use of the medical device.


Question

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


Answer

According to requirements and standards of the approved quality management system in the manufacturer.


Question

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?


Answer

The Annex specifies the requested information in the Field Safety Notice, other information may be added by the manufacturer, according to the type of the problem and the corrective or preventive actions to reduce or remove a risk.


Question

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?


Answer

Yes, manufacturer through its Authorized Representative (AR) or importer shall report to the SFDA any Field Safety Corrective Action when the KSA is affected within (2) working days from Field Safety Corrective Action issuance date by manufacturer


Question

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?


Answer

Yes, KSA is considered as not affected.


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