Enforcement record

Recommendation disclosure naming 医療機器産業連合会、AMDD、EBC

医療機器産業連合会、AMDD、EBC (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 disclosure

Action type

Recommendation

Law

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

Authority

Ministry of Health, Labour and Welfare

Action date

Unknown

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-202608042059
Generated at: 5 August 2026 at 05:59
Record URL: https://regbase.jp/en/enforcement/yakkiho-yi-liao-ji-qi-chan-ye-lian-he-huiamddebc-unknown

1. Review Summary

Disclosure name	医療機器産業連合会、AMDD、EBC	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	Unknown	Authority	Ministry of Health, Labour and Welfare
Law	Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices	Action type	Recommendation
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、AMDD、EBC

3. Enforcement Record

Target name in disclosure	医療機器産業連合会、AMDD、EBC
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 / Recommendation
Action / announcement date	Action: Unknown / Announcement: 27 April 2026
English summary	Construction of a medical device database, mandatory registration of UDI information, promotion of medical data utilization, regulatory harmonization of clinical trials and research, investigation and improvement of device loss, development of guidelines for medical advertising, strengthening of regulations on cross-border e-commerce, response to environmental regulations, international harmonization of QMS surveys, review of business practices, and revision of management qualification requirements.
Original Japanese text	医療機器データベースの構築、UDI情報登録義務、医療データの利活用促進、臨床試験・研究の規制調和、デバイスロスの調査と改善、医療広告のガイドライン整備、越境ECの規制強化、環境規制への対応、QMS調査の国際整合、業態見直し、管理者資格要件の見直しなど。
Official source	https://www.mhlw.go.jp/stf/newpage_65484.html
Source archive	https://kiroku.today/a/8869646b79h5cx6x
Extraction / evidence timestamps	Extracted: 27 April 2026 at 21:01 / Evidence checked: 27 April 2026 at 21:01 / Archive captured: 27 April 2026 at 21:02

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

Save the disclosure record naming 医療機器産業連合会、AMDD、EBC

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Preserved evidence by Kiroku

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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%E3%80%81AMDD%E3%80%81EBC&limit=10

Open JSON Specs

Action summary

Company: 医療機器産業連合会、AMDD、EBCJapanese only
Original: 医療機器産業連合会、AMDD、EBC
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type: Recommendation
勧告
Action date: Unknown
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医療機器・医薬品

Violation

Machine-translated summary — verify against original

Construction of a medical device database, mandatory registration of UDI information, promotion of medical data utilization, regulatory harmonization of clinical trials and research, investigation and improvement of device loss, development of guidelines for medical advertising, strengthening of regulations on cross-border e-commerce, response to environmental regulations, international harmonization of QMS surveys, review of business practices, and revision of management qualification requirements.

Show original Japanese text

医療機器データベースの構築、UDI情報登録義務、医療データの利活用促進、臨床試験・研究の規制調和、デバイスロスの調査と改善、医療広告のガイドライン整備、越境ECの規制強化、環境規制への対応、QMS調査の国際整合、業態見直し、管理者資格要件の見直しなど。

Compliance context

Medium

A regulator issued a recommendation or formal request for corrective action.

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

Review the facts and follow-up status. This is usually less severe than a suspension or revocation, but still a public enforcement signal.

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: 2026-04-27T12:01:51.544+00:00
Evidence checked: 2026-04-27T12:01:51.544+00:00
Archive captured: 2026-04-27T12:02:02.840529+00:00

Show audit JSON

{
  "record": {
    "id": "65f74e08-58ff-4c08-bd3c-5968162e1fbd",
    "url": "https://regbase.jp/en/enforcement/yakkiho-yi-liao-ji-qi-chan-ye-lian-he-huiamddebc-unknown",
    "company_name_original": "医療機器産業連合会、AMDD、EBC",
    "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": "勧告",
      "en": "Recommendation"
    },
    "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": "Medium",
    "actionMeaning": "A regulator issued a recommendation or formal request for corrective action.",
    "practicalNote": "Review the facts and follow-up status. This is usually less severe than a suspension or revocation, but still a public enforcement signal.",
    "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-huiamddebc-unknown",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_65484.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/8869646b79h5cx6x",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_65484.html",
    "archiveCapturedAt": "2026-04-27T12:02:02.840529+00:00",
    "extractedAt": "2026-04-27T12:01:51.544+00:00",
    "translatedAt": "2026-05-01T09:43:10.277+00:00",
    "evidenceCheckedAt": "2026-04-27T12:01:51.544+00:00",
    "generatedAt": "2026-08-04T20:59:14.448Z"
  },
  "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.