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Minor change finder

Describe the change in one sentence and it finds the matching item number in Annex 3, minor changes of 「의료기기 허가·신고·심사 등에 관한 규정」, tells you whether it is a 30-day or an annual report (Article 19 ⑤ and ⑥), and checks against the Annex 4 flowchart whether it is in fact a variation rather than a minor change.

It first reads what your sentence is about (supplier, manufacturer, model name, packaging…) and what happened to it (renamed, transferred, deleted, recoloured…), maps that onto the Annex 3 items, then narrows further by wording, synonyms and meaning. Click an item number to see the text in full.

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When to report — Article 19 ⑤ (annual) · ⑥ (30 days)
When it is not minor — Article 19 ① (new approval) · ② (variation) · Article 19-2 (software)
Annex 4 decision flowchart (original)
Class-certified or notified items · entry on the back of the licence · six-month grace for product made before the change — Article 19 ⑦⑧ and Article 19-3

This tool is free. Why we started this · The data is built from MFDS notices and every result carries its source.

This result is for reference and has no legal force. The Annex 3 item wording and the 30-day vs annual split are taken from the notice; the mapping from your sentence to an item and the “not a minor change” signal are REGNA's own. Confirm what must be reported, and when, against the notice and the entries on your licence. A minor change report is filed on Form 1 (electronic document).