The updated announcement for the Device Defect or Adverse Event (AE) Report and Field Safety Corrective Action (FSCAs) Report 2020 effectively supersedes the 2016 version. The following procedure describes the amended guidelines:
For Device Defect or Adverse Event (AE)
a) Domestic
1. Initial report
1.1 Within 48 hours for "Serious threat to public health"
1.2 Within 10 days for "Death or Serious injury"
1.3 Within 30 days for "Potential to cause death or serious injury if the event recurs"
2. Follow up report within 30 days after initial report.
b) Device Defect or Adverse Event (AE) which occurred inf countries shall be reported to Thai FDA twice a year. If it occurs in January – June, it shall be reported by August and if in July - December, it shall reported by February.
Field Safety Corrective Action (FSCAs) Report in both Domestic and Foreign countries
a) Initial report within 48 hours of implementation of the FSCA
b) Follow up report within 21 days after previous report
Remarks: This decree shall be in force by February 5th, 2021 onwards.