FAQ
FAQ
What are the expected outcomes of post-marketing evaluation studies?
• Corrective actions
• Preventative measurements
• Request additional clinical studies to provide the evidence of the safety and efficiency of the medical device
• Disseminating safety communication to users and health care providers
What do we mean by post-marketing evaluation studies?
These are studies that are conducted with a scientificmethodology on a medical device to verify its safety / effectiveness as a result of the presence of safety signals on that device that is marketed locally
Is the approval of SFDA required to conduct a clinical study on a medical device ?
SFDA represented by the medical devices sector requires obtaining prior approval before conducting any clinical study in accordance with the requirements mentioned in the 'Guideline for the Requirements of Clinical Studies for Medical Devices and Products (MDS - G20) and in compliance with the International Standard (ISO 14155) Concerning Good Clinical Practice.
The guidelines of the requirements for conducting clinical studies on medical devices can be referred to through the following links on the SFDA website:
- النسخة العربية: https://sfda.gov.sa/sites/default/files/2020-09/MDS-G20a.pdfG20)ar.pdf
- النسخة الإنجليزية: https://sfda.gov.sa/sites/default/files/2020-09/MDS-G20e_0.pdf
If software update for a medical device imported to KSA is released, but this update is only for improvement not due to a problem or malfunction in the device. Is it mandatory to inform SFDA about this action and provide all the requirements for its closure?
In case there is a problem or malfunction affects patient or user’s safety, the manufacturer should issue the Field Safety Corrective Action and inform SFDA accordingly.
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?
The manufacturer is responsible for the medical devices marketed in the KSA, as well as the supplier and distributor.
If Field Safety Corrective Action is issued by the manufacture on specific serial or lot numbers, and these products with these numbers have not been imported into the KSA or put on the market, should we inform the SFDA about this Field Safety Corrective Action?
No, KSA is considered not affected in this case. But in case SFDA inquires about these products, you must provide a statement confirming KSA is Not Affected by Field Safety Corrective Action.
In the event that a corrective action is issued by the factory, is it necessary for affected customers to be notified immediately even before the corrective plan is provided?
Yes, and they should be informed again if there are additional corrective or preventive recommendations or actions.
In case of receiving inquiries from SFDA about a medical device Field Safety Corrective Action that they received from more than one source, but for the company is considered as one Field Safety Notice should all of them be closed, or it should be reported that they are the same Field Safety Notice which was previously answered?
SFDA must be informed of any duplicated Field Safety Notices and any updated information related to affected medical device or the corrective action.
If a new Field Safety Corrective Action is issued and there is no affected device in KSA, but we as a manufacturer know that there is a request for a number of devices that will be available in the Kingdom (e.g. after two months), in this case, does KSA considered affected or not?
Any affected device should not be imported until the corrective action is implemented and providing SFDA with supporting documents.