E
Ethan Loh
Hi everyone,
What are the differences between STED and CSDT?
Please advice.
What are the differences between STED and CSDT?
Please advice.
Re: Differences between STED (Summary Technical Document) and CSDT
My guess: Common Submission Dossier Template - part of the Asean Medical Device Directive (AMDD)
My guess: Common Submission Dossier Template - part of the Asean Medical Device Directive (AMDD)
S
SteveK
Re: Differences between STED (Summary Technical Document) and CSDT
Hi Ethan,
Have a look at this article:
https://www.mpo-mag.com/articles/2009/01/asean-medical-device-regulatory-integration
Extract:
"The two documents are similar, but they are not exactly the same. One difference is the CSDT’s “device description” section contains additional items. They include device counterindications, potential adverse effects and alternative therapies."
I hope this helps
Steve
Hi everyone,
What are the differences between STED and CSDT?
Please advice.
Hi Ethan,
Have a look at this article:
https://www.mpo-mag.com/articles/2009/01/asean-medical-device-regulatory-integration
Extract:
"The two documents are similar, but they are not exactly the same. One difference is the CSDT’s “device description” section contains additional items. They include device counterindications, potential adverse effects and alternative therapies."
I hope this helps
Steve
pseudoazurin
Involved In Discussions
Re: Differences between STED (Summary Technical Document) and CSDT
Is the comparison still of interest to anyone? I think AHWP got a comparison or is doing such a comparison.
Is the comparison still of interest to anyone? I think AHWP got a comparison or is doing such a comparison.
Hi everyone,
Differences of CSDT (AMDD) and Technical File (MDD) in my understanding:
1) Classification: AMDD class A, B, C, D and the responsibilities of each. Class A require only e-listing; others need CSDT submission which include clinical study/evaluation. Class D and implant need clinical investigation.
2) 19 items x Essential Performance..(AMDD), compared to 14 items x Essential requirements (MDD)
3) Some document must be in local language, such as Risk Management File
4) Labeling/instruction in local language.
I would recommend big help from a professional consultant firm / Authorized agent in the country you submit CSDT.
Hope this help.
Cheers,
Pete
Differences of CSDT (AMDD) and Technical File (MDD) in my understanding:
1) Classification: AMDD class A, B, C, D and the responsibilities of each. Class A require only e-listing; others need CSDT submission which include clinical study/evaluation. Class D and implant need clinical investigation.
2) 19 items x Essential Performance..(AMDD), compared to 14 items x Essential requirements (MDD)
3) Some document must be in local language, such as Risk Management File
4) Labeling/instruction in local language.
I would recommend big help from a professional consultant firm / Authorized agent in the country you submit CSDT.
Hope this help.
Cheers,
Pete
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