Possible Administrative Guidance against 医療機器メーカー

医療機器メーカー (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfarePossible entity match

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/api/v1/enforcements?company=%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%83%A1%E3%83%BC%E3%82%AB%E3%83%BC&limit=10

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Action summary

Company: 医療機器メーカーJapanese original
Original: 医療機器メーカー
Entity match: Possible entity match60/100Machine extracted
Company name extracted from the Japanese public disclosure
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type: Administrative Guidance
行政指導
Action date: Unknown
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

In 2019, the Pharmaceuticals and Medical Devices Act was amended to establish a system considering the characteristics of medical devices such as IDATEN, and its enforcement has commenced. Such systems need to adapt to the rapidly evolving medical technologies, medical devices, in vitro diagnostic reagents, and software medical devices.

Show original Japanese text

令和元年に薬機法が改正されて、いわゆるIDATENなどの医療機器の特性を踏まえた制度ができ、その施行もされております。こうした制度というものは、日々、日進月歩で変わる医療技術、医療機器・体外診断薬、あるいはプログラム医療機器などに対応したものとする必要があります。

Compliance context

Low-medium

Administrative guidance or supervision was publicly disclosed by the authority.

Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.

Use as a monitoring signal. Confirm details before treating it as a formal sanction.

This context is an operational aid for review workflows, not a credit opinion or legal conclusion.

Evidence pack

Original Ministry of Health, Labour and Welfare announcement (Japanese)Archived source snapshot

Extracted at: 2026-04-24T23:37:42.616+00:00
Evidence checked: 2026-04-24T23:37:42.616+00:00
Archive captured: 2026-04-03T06:51:09.322+00:00

Show audit JSON

{
  "record": {
    "id": "705c62e6-fadc-49f3-9833-74ab7d06837d",
    "url": "https://regbase.jp/en/enforcement/yakkiho-yi-liao-ji-qi-meka-unknown",
    "company_name_original": "医療機器メーカー",
    "company_name_registry": "医療機器メーカー",
    "corporate_number": null,
    "law": {
      "ja": "薬機法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "行政指導",
      "en": "Administrative Guidance"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "possible",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": null
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Low-medium",
    "actionMeaning": "Administrative guidance or supervision was publicly disclosed by the authority.",
    "practicalNote": "Use as a monitoring signal. Confirm details before treating it as a formal sanction.",
    "lawContext": "Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/yakkiho-yi-liao-ji-qi-meka-unknown",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_21919.html",
    "archiveUrl": "https://kiroku.today/view/2077ea6711ijow9q",
    "archiveCapturedAt": "2026-04-03T06:51:09.322+00:00",
    "extractedAt": "2026-04-24T23:37:42.616+00:00",
    "translatedAt": "2026-05-01T06:51:50.121+00:00",
    "evidenceCheckedAt": "2026-04-24T23:37:42.616+00:00",
    "generatedAt": "2026-06-19T10:40:54.487Z"
  },
  "limitations": [
    "RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
    "English summaries are provided for reference. The original Japanese source is authoritative.",
    "Possible or unresolved entity matches should be manually verified before use in a decision."
  ]
}

The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.

Language

日本語版を見る (Japanese)

Company info

English name: 医療機器メーカー Japanese original
Japanese name: 医療機器メーカー

See company profile →

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.