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What should be done immediately after the incident? FAQ

Are the requirements for reporting incidents and adverse events of medical devices included in clinical studies different from the general requirements? FAQ

SFDA urges home users to report accidents and problems of home use medical devices FAQ

"What is Field Safety Corrective Action?" FAQ

What is the procedure followed to appoint a manufacturer liaison officer or his authorized representative with SFDA? FAQ

When does SFDA set requirements for corrective actions for reported devices? FAQ

What is a Field Safety Notice? FAQ

What is required of the authorised representative in the event that the distributor (s) do not respond to him / her regarding the implementing of Field Safety Corrective Action? FAQ

"If the authorised representative of a manufacturer has a authorised representation certificate for devices classified with a specific classification, but the device affected by the Field Safety Corrective Action is not from the production line responsible for it even though it is of the same classification, is he responsible for closing the Field Safety Corrective Action for this device? " FAQ

How do I make sure that the Field Safety Corrective Action has been closed? FAQ