Korea · Medical devices & IVDs
Korean device regulation, finally searchable
Korea publishes its device rules as HWP attachments and board posts. You cannot search them, and a revision history does not always say what really changed. REGNA reads the primary sources and answers narrow questions from them — free, no sign-up.
What you can look up
Each tool answers one question from the notice itself, and shows the notice name, number, effective date and annex it read.
The tools are in Korean, on purpose
The answers are Korean regulatory terms — item names, notice numbers, annex rows — and they have to match what you actually file. Translating them would create a second vocabulary that no reviewer recognises. If you work with a Korean partner, agent or consultant, these pages give you the same primary source they are reading.
KGMP product-group finder
Look up which GMP product group (품목군) an item code belongs to, straight from Annex 3 of the GMP notice.
/gmp →Product standard finder
Find the individual product standard (기준규격) for an item code, or see that none is designated and which common standards apply instead.
/standard →Biological safety test selector
Pick contact type and duration; get the required ISO 10993 evaluations under the Korean common standard, with the clauses that sit outside the table.
/bio →Minor change or variation
Check whether a change can be reported as a minor change (경미한 변경) under the review regulation, with the annex row and reporting deadline.
/change →Digital medical device classifier
Decide whether software is a digital medical device under the Digital Medical Products Act, build the 7-digit product code and read the grade from the status-impact matrix.
/digital →KGMP audit statistics
What Korean GMP audits actually ask for: three years of supplementary-request notices grouped by document type, with the real sentences and the Annex 2 clause they map to.
/kgmp →Document redaction
Strip names, numbers and company details from a PDF in your browser. Nothing is uploaded.
/mask →Regulatory news
Korean, US and EU medical device changes, each with the primary source.
/news →Where the answers come from
Nothing here is written from memory. Every tool is built from published Korean sources, and each build checks the version in force before it replaces what it had.
- Notices and statutes — pulled from the National Law Information Center (law.go.kr), including the HWPX annexes that hold the tables. The build compares the notice number and effective date against the version in force and stops if they disagree.
- MFDS guidance — the full medical device set of public guidance documents (민원인 안내서) and reviewer manuals (공무원 지침서), kept current as they are revised.
- MFDS open data — item information, GMP supplementary-request records and related APIs published through data.go.kr.
- Version tracking — MFDS replaces a guidance document by posting a new one and taking the old post down. We keep both, so when a document is revised we can compare the full text, not just the revision note. That has already caught paragraphs removed without being listed.
Who this is for
- Manufacturers entering Korea — check classification, grade, applicable standards and GMP scope before you commit to a filing strategy.
- RA consultants and agents — stop re-reading annexes by eye; link a client straight to the clause.
- Quality teams preparing a KGMP audit — see what Korean auditors actually raised over three years, in their own words.
- Anyone tracking Korean changes — the news page follows MFDS, FDA and EU updates with the primary source attached.
For teams: REGNA Office
Beyond the free tools there is a workbench for RA teams — regulatory Q&A that cites the clause it relied on, document redaction, technical file review, team channels and mail. It requires an account and its interface is Korean. Write to us if you want a walkthrough.
Hear about it when we ship
We add tools as we hit the next thing that is hard to look up. Leave an address and we will write when a new one opens — nothing else.
Independence and sources
REGNA is a private service operated by 테일게이트랩 (TailgateLab). It is not affiliated with, endorsed by, or acting on behalf of the Ministry of Food and Drug Safety or any other regulator. Public works are used under Article 24-2 of the Korean Copyright Act and attributed under Article 37; we do not display the Korea Open Government License mark or any agency logo, because that mark belongs to the institution that opens the work.