Enforcement record

Recommendation disclosure naming 米国医療機器・IVD工業会（AMDD）

米国医療機器・IVD工業会（AMDD） (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 disclosure14 September 2023

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

14 September 2023

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-MI-GUO-YI-202608041530
Generated at: 5 August 2026 at 00:30
Record URL: https://regbase.jp/en/enforcement/yakkiho-mi-guo-yi-liao-ji-qi-ivdgong-ye-huiamdd-20230914

1. Review Summary

Disclosure name	米国医療機器・IVD工業会（AMDD）	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	14 September 2023	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	米国医療機器・IVD工業会（AMDD）

3. Enforcement Record

Target name in disclosure	米国医療機器・IVD工業会（AMDD）
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: 14 September 2023 / Announcement: 21 April 2026
English summary	Exchange of opinions on efforts toward international harmonization and reference country standardization
Original Japanese text	国際整合とリファレンスカントリー化に向けた取組についての意見交換
Official source	https://www.mhlw.go.jp/stf/newpage_35771.html
Source archive	https://kiroku.today/a/7547e0e12adenpzu
Extraction / evidence timestamps	Extracted: 25 April 2026 at 09:26 / Evidence checked: 25 April 2026 at 09:26 / Archive captured: 14 June 2026 at 15:33

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 米国医療機器・IVD工業会（AMDD）

Includes the published name, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.

Preserved evidence by Kiroku

Review the preserved source for 米国医療機器・IVD工業会（AMDD）

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

You do not need this for normal browsing. Use it only when integrating this enforcement record into an internal tool or AI workflow.

/api/v1/enforcements?company=%E7%B1%B3%E5%9B%BD%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%83%BBIVD%E5%B7%A5%E6%A5%AD%E4%BC%9A%EF%BC%88AMDD%EF%BC%89&limit=10

Open JSON Specs

Action summary

Company: 米国医療機器・IVD工業会（AMDD）Japanese only
Original: 米国医療機器・IVD工業会（AMDD）
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type: Recommendation
勧告
Action date: 14 September 2023
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医療機器国際規制

Violation

Machine-translated summary — verify against original

Exchange of opinions on efforts toward international harmonization and reference country standardization

Show original Japanese text

国際整合とリファレンスカントリー化に向けた取組についての意見交換

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: 2026-04-25T00:26:45.691+00:00
Evidence checked: 2026-04-25T00:26:45.691+00:00
Archive captured: 2026-06-14T06:33:43.074199+00:00

Show audit JSON

{
  "record": {
    "id": "5d0d965a-1c1b-4480-a461-c7e0b5b58612",
    "url": "https://regbase.jp/en/enforcement/yakkiho-mi-guo-yi-liao-ji-qi-ivdgong-ye-huiamdd-20230914",
    "company_name_original": "米国医療機器・IVD工業会（AMDD）",
    "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-mi-guo-yi-liao-ji-qi-ivdgong-ye-huiamdd-20230914",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_35771.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/7547e0e12adenpzu",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_35771.html",
    "archiveCapturedAt": "2026-06-14T06:33:43.074199+00:00",
    "extractedAt": "2026-04-25T00:26:45.691+00:00",
    "translatedAt": "2026-05-01T07:14:38.465+00:00",
    "evidenceCheckedAt": "2026-04-25T00:26:45.691+00:00",
    "generatedAt": "2026-08-04T15:30:38.674Z"
  },
  "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.