EASY REGNA TOOLS Free · no sign-in
Medical device regulatory work,
Make it Easy
REGNA knows where a QA/RA specialist's time actually goes. Downloading an annex and comparing it by eye, opening guidance documents one at a time — this is a set of free tools that shortens the part you repeat every time.
What works right now
No upload · no account · all free
TOOLS · 8
Tools available now
Everything runs in your browser, and every result comes with the notice it relied on and a link to the original.
KGMP product group finder
Enter an item code or item name and the GMP product group and grade come back with the notice they rest on. No more scrolling Annex 3 of the GMP notice.
Open toolProduct standard finder
Search by item code or name for the Korean individual product standard in the 「의료기기 기준규격」 notice, plus the ISO/IEC standards it refers to. Common standards are pointed out too.
Open toolBiological safety test selector
Choose the contact site and duration and you get the biological evaluations required. Taken straight from the annex of the common standard on biological safety.
Open toolEasy redaction
Drop in a PDF and personal data, company names and figures are found and genuinely removed — you get a redacted PDF and a text version. Nothing is uploaded, no account needed.
Open toolDigital device: in scope, code, grade
Whether standalone software, AI or a digital therapeutic counts as a digital medical device, how the 7-digit product code is built and which grade applies — taken from the annexes of the classification and grading rule and the MFDS guidance cases.
Open toolMinor change finder
Describe the change in one sentence and it finds the matching item number in Annex 3 of the review regulation and whether it is a 30-day or annual report, then uses the Annex 4 flowchart to check it is not a variation instead.
Open toolRegulatory news
MFDS statutes and notices, Korean regulatory trends, and FDA/EU developments, selected and summarised by REGNA. Every item links to the primary source.
Open toolKGMP audit statistics
Pick a product group to see what three years of GMP audits most often asked to supplement, in the actual wording of the notices. The clause wiki puts those notices next to the Annex 2 requirements they belong to.
Open toolWant to hear when a new tool opens?
We turn the things that hold up real work into tools, one at a time. When a new one opens we send a single email. You can keep using every tool without subscribing.
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