Similarities between format of technical file for CE and ASEAN common submission dossier template (CSDT)

Gandhali

Registered
Hello, I am currently working in Medical device industry. We are looking to export our products in Africa, Middle East and South East Asia. If we prepare the technical file as per EU MDR 2017, would we able to prepare the ASEAN CSDT document with minor changes by ourselves? How similar are these two formats?
 

WAQAR-QMS

Medical Devices Expert
It depends on your skill on relevant regulations.
But it can be tricky and mess up your registration process.
You should have a some pro involve in this.
 
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