FAQs

Manufacturers, Authorized Representative, Importers, Distributors shall report to the SFDA, upon becoming aware that adverse event, incident, a complaint has occurred, as follows: − Not later than (2) working days from the date of awareness, if the adverse event, incident, and complaint represent a serious public health threat. − Not later than (10) working days from the date of awareness if the adverse event, incident, complaint that results in an unanticipated death or unanticipated serious injury.

Refer to SFDA requirements in this regard, as well as the following procedural rules and guidelines: • Implementing Rule for licensing facilities (MDS-IR4) https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/implementing_rules.aspx • Post-Marketing Control Implementing Rule (MDS-IR7) https://www.sfda.gov.sa/en/medicaldevices/regulations/Pages/implementing_rules.aspx • Relevant Guidance

Not necessarily, and regulatory bodies often take the manufacturer's recommendations into account in such cases, and it is not prohibited to add some requirements according to each case separately.  

Yes, KSA is considered as not affected.

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