Hi,
A. Adverse Events
1. Singapore +EU+ Canada:
Resulted in death or serious injury or malfunction: Initial report in 10 days; final report in 30 days
Could result in death or serious injury if re-occurred: Single report in 30 days(initial/final)
Could cause serious threat to public health: initial report in 2 days; final report in 30 days for SG and EU; For Canada, up on agreed time-line between Ministry and Manufacturer
2. China:
i. Within 5 working days for an AE that caused death
ii. Within 15 working days for an AE that caused or may cause serious injury
iii. Annual report to SFDA summarizing all AEs, in January every year.
3. Taiwan:
i. Pharmaceutical dealers holding the permit license of the medical device have 15 calendar days after becoming aware of a serious AE drug reaction to submit a report. (thi is applicable for both drugs and medical devices).
ii. A complete follow-up report within 8 additional calendar days.
4. New Zealand:
i. death (actual or potential): within 7 calendar days
ii. Serious Injury (actual or potential ): within 7 calendar days
iii. Injury (actual or potential): Within 30 calendar days
iv. No injury: within 30 calendar days
B. Field Safety Corrective Action (FSCA) Reporting
1. Singapore:
Field Safety Notice/Recall Notice: within 24 hrs
Initial FSCA report: 24hrs from commencement of FSCA
final FSCA report: within 21 days
2. Canada
FSN/Recall Notice: before start implementation of FSCA
Initial Report: Not applicable
Final Report: Soon after the completion of FSCA/Recall
3. EU
FSN: Immediately, not later than 48 hrs
Initial Report: Immediately, not later than 10 days
Final FSCA Report: Immediately, not later than 30 days
Regards,
Sreenu