Taiwan Medical Device Adverse Event Reporting

E

Ethan Loh

#1
Hi everybody,

My company is planning to market some medical device in Taiwan and we need to have a medical device adverse event reporting procedure.

Can anybody share their adverse event report on Taiwan?:)
 
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Stijloor

Staff member
Super Moderator
#2
Hi everybody,

My company is planning to market some medical device in Taiwan and we need to have a medical device adverse event reporting procedure.

Can anybody share their adverse event report on Taiwan?:)
Can someone help Ethan?

Thank you!

Stijloor.
 

Ajit Basrur

Staff member
Admin
#3
Hi everybody,

My company is planning to market some medical device in Taiwan and we need to have a medical device adverse event reporting procedure.

Can anybody share their adverse event report on Taiwan?:)
Taiwan accepts GHTF documents and hence you can adopt the practise as per GHTF Document on Adverse Event Reporting, SG2 N21R8 that I have attached.

You could also refer the FAQs on Adverse Event Reporting issued by Department of Health (DOH), Taiwan.

.
 

Attachments

J

JenniferLe

#6
Can anyone provide a more up-to-date document on Taiwan's requirement for reporting Medical device-related events? Or is the response and attachment on GHTF document from 2005 still valid?

I am also looking for an English version of Taiwan's equivalent documents to US FDA 21CFR812 (Medical device) and Part 50 (Protection of Human Subjects) and 56 (IRB)?

Any assistance is greatly appreciated.
 

Ajit Basrur

Staff member
Admin
#7
Can anyone provide a more up-to-date document on Taiwan's requirement for reporting Medical device-related events? Or is the response and attachment on GHTF document from 2005 still valid?

I am also looking for an English version of Taiwan's equivalent documents to US FDA 21CFR812 (Medical device) and Part 50 (Protection of Human Subjects) and 56 (IRB)?

Any assistance is greatly appreciated.
I donot have any updates.

Does anyone have answers for JenniferLe's question ?
 
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