Enforcement record

Administrative Guidance disclosure naming 医療機器産業連合会（医機連）

医療機器産業連合会（医機連） (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareGovernment disclosure1 September 2024

Action type

Administrative Guidance

Law

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

Authority

Ministry of Health, Labour and Welfare

Action date

1 September 2024

RegBase evidence report

Japanese public-record enforcement check

Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.

Report ID: RB-EN-ENFORCEMENT-YAKKIHO-YI-LIAO-J-202608041532
Generated at: 5 August 2026 at 00:32
Record URL: https://regbase.jp/en/enforcement/yakkiho-yi-liao-ji-qi-chan-ye-lian-he-huiyi-ji-lian-20240901

1. Review Summary

Disclosure name	医療機器産業連合会（医機連）	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	1 September 2024	Authority	Ministry of Health, Labour and Welfare
Law	Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices	Action type	Administrative Guidance
Source status	Preserved public-source archive recorded

This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.

2. Published Information

Published name	医療機器産業連合会（医機連）

3. Enforcement Record

Target name in disclosure	医療機器産業連合会（医機連）
Authority	Ministry of Health, Labour and Welfare (厚生労働省)
Law / action type	Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices / Administrative Guidance
Action / announcement date	Action: 1 September 2024 / Announcement: 27 April 2026
English summary	Development of human resources for medical devices, streamlining regulations, international regulatory harmonization, improving certification systems, cybersecurity measures, rationalizing QMS, enhancing registry reliability, promoting work style reforms, advancing electronic applications and digitization, and strengthening collaboration with overseas regulatory authorities.
Original Japanese text	医療機器の人材育成、規制の合理化、国際規制調和、認証制度の改善、サイバーセキュリティ対策、QMSの合理化、レジストリの信頼性向上、働き方改革の推進、電子申請・電子化の促進、海外規制当局との連携強化。
Official source	https://www.mhlw.go.jp/stf/newpage_13968.html
Source archive	https://kiroku.today/a/9512ba6ebbgfmie5
Extraction / evidence timestamps	Extracted: 27 April 2026 at 09:01 / Evidence checked: 27 April 2026 at 09:01 / Archive captured: 27 April 2026 at 09:02

4. Business Location and Permit Details

No additional structured business-location or permit fields are recorded for this disclosure.

5. Other Confirmed Records for This Company

This report covers the single government disclosure shown on this page.

Reviewer Notes

Reviewer		Team / company
Review purpose
Additional notes

□ Official source URL or archived source was checked.
□ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
□ This document is understood as a public-record evidence file, not a credit decision or legal opinion.

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Free report

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Preserved evidence by Kiroku

Review the preserved source for 医療機器産業連合会（医機連）

Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.

Open preserved source and evidence pack

For developers: JSON integration details

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/api/v1/enforcements?company=%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E7%94%A3%E6%A5%AD%E9%80%A3%E5%90%88%E4%BC%9A%EF%BC%88%E5%8C%BB%E6%A9%9F%E9%80%A3%EF%BC%89&limit=10

Open JSON Specs

Action summary

Company: 医療機器産業連合会（医機連）Japanese only
Original: 医療機器産業連合会（医機連）
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: 1 September 2024
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医療機器・規制調和

Violation

Machine-translated summary — verify against original

Development of human resources for medical devices, streamlining regulations, international regulatory harmonization, improving certification systems, cybersecurity measures, rationalizing QMS, enhancing registry reliability, promoting work style reforms, advancing electronic applications and digitization, and strengthening collaboration with overseas regulatory authorities.

Show original Japanese text

医療機器の人材育成、規制の合理化、国際規制調和、認証制度の改善、サイバーセキュリティ対策、QMSの合理化、レジストリの信頼性向上、働き方改革の推進、電子申請・電子化の促進、海外規制当局との連携強化。

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 source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-04-27T00:01:30.932+00:00
Evidence checked: 2026-04-27T00:01:30.932+00:00
Archive captured: 2026-04-27T00:02:31.416389+00:00

Show audit JSON

{
  "record": {
    "id": "6a4a1578-0692-40d8-a2e7-61bb6c4bf533",
    "url": "https://regbase.jp/en/enforcement/yakkiho-yi-liao-ji-qi-chan-ye-lian-he-huiyi-ji-lian-20240901",
    "company_name_original": "医療機器産業連合会（医機連）",
    "company_name_registry": null,
    "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": "unresolved",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": "The linked company profile has not been verified under the current identity policy."
  },
  "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-chan-ye-lian-he-huiyi-ji-lian-20240901",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_13968.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/9512ba6ebbgfmie5",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_13968.html",
    "archiveCapturedAt": "2026-04-27T00:02:31.416389+00:00",
    "extractedAt": "2026-04-27T00:01:30.932+00:00",
    "translatedAt": "2026-05-01T09:42:24.606+00:00",
    "evidenceCheckedAt": "2026-04-27T00:01:30.932+00:00",
    "generatedAt": "2026-08-04T15:32:31.483Z"
  },
  "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)

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