Overview
A Taiwanese medical device manufacturer had received a rejection from MDA on their Class B device their third attempt in 18 months. They came to us after two previous submissions by a competitor agency had failed.
We identified the root cause, rebuilt the dossier, and secured approval on our first submission.
The Challenge
Three previous rejections all citing different documentation deficiencies suggesting a structural misunderstanding of MDA Class B device requirements. Technical files prepared for ISO 13485 standards but did not align with MDA specific submission format requirements.
Our Approach
Full root-cause analysis of all three rejection letters. Rebuilt the entire technical file in MDA-required format, translated and reformatted ISO documentation to meet local standards, and conducted a pre-submission
review with our MDA liaison contacts.
The Outcome
MDA approval received on first submission. The client's Malaysian distributor launched commercial sales within the
same quarter.