THAILAND: Updated Regulation on the Device Defect or Adverse Event (AE) Report and Field Safety Corrective Action (FSCAs) Report 2020

• 2021-02-22 02:20:12

This newest announcement is regarding the Device Defect or Adverse Event (AE) Report and Field Safety Corrective Action (FSCAs) Report. It targets to increase level of post-marketing surveillance by including the reporting of device defect or adverse event which occurred in foreign countries.

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SINGAPORE: FSCA reporting made easy: HSA introduces OSCAR – March, 2019

• 2020-05-06 05:36:45

Using the available digital technologies, HSA is seeking to improve their Post Market Surveillance mechanism via Field Safety Corrective Action (FSCA) reporting. Last March 2019, has introduced OSCAR, their new Online System which will serve as a one-stop platform for FSCA.

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