Before any medical device registration application is submitted, dozens of technical files pass across review desks, and we consistently notice the same gaps recurring — regardless of the product or manufacturer. Here are the most common ones.
One of the most frequent findings: the narrative text in the file cites a particular international standard (such as an ISO standard), while the attached test report actually relies on a different local standard (such as a Chinese or other national standard), with no equivalence table showing that one covers the requirements of the other. This inconsistency usually triggers a formal deficiency from the authority.
Many technical files are built on ready-made templates, and traces of the previous product sometimes remain (a different product name in the page header, or "clinical benefit" paragraphs describing an entirely different device). These details may seem minor, but they reveal that the file wasn't reviewed carefully enough.
When using a predicate device methodology in clinical evaluation, the evidence provided must relate to a genuine, documented equivalent device — not a competitor's retail product photo without any real technical equivalence analysis.
Some files simply state that "the product was tested and results conform" without attaching an actual test report or verifiable data.
We review the technical file item by item before submission, cross-checking every reference to a standard or data point in the narrative text against the actual supporting document, to reduce the likelihood of deficiencies and speed up the registration pathway.
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