Enforcement record
Recommendation disclosure naming 日本臨床検査薬協会
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
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-RI-BEN-LI-202608042310
- Generated at
- 5 August 2026 at 08:10
- Record URL
- https://regbase.jp/en/enforcement/yakkiho-ri-ben-lin-chuang-jian-cha-yao-xie-hui-unknown
1. Review Summary
| Disclosure name | 日本臨床検査薬協会 | 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 | 日本臨床検査薬協会 |
|---|
3. Enforcement Record
| Target name in disclosure | 日本臨床検査薬協会 |
|---|---|
| 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 | Review of the classification of in vitro diagnostics, international harmonization of regulations, digitization of package inserts, revision of administrator qualification requirements, optimization of regulation and review, standardization of in vitro diagnostics, and explanation of the history and current status of regulations. |
| Original Japanese text | 体外診のクラス分類の見直し、規制の国際整合、添付文書の電子化、管理者資格要件の見直し、規制と審査の最適化、体外診の自主基準化、規制の歴史と現状の説明。 |
| 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
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Preserved evidence by Kiroku
Review the preserved source for 日本臨床検査薬協会
Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.
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Action summary
- Company
- 日本臨床検査薬協会Japanese onlyOriginal: 日本臨床検査薬協会
- 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
- 臨床検査薬
Violation
Review of the classification of in vitro diagnostics, international harmonization of regulations, digitization of package inserts, revision of administrator qualification requirements, optimization of regulation and review, standardization of in vitro diagnostics, and explanation of the history and current status of regulations.
Show original Japanese text
体外診のクラス分類の見直し、規制の国際整合、添付文書の電子化、管理者資格要件の見直し、規制と審査の最適化、体外診の自主基準化、規制の歴史と現状の説明。
Compliance context
MediumA 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
- Extracted at
- 2026-04-27T12:01:53.108+00:00
- Evidence checked
- 2026-04-27T12:01:53.108+00:00
- Archive captured
- 2026-04-27T12:02:02.840529+00:00
Show audit JSON
{
"record": {
"id": "9610da04-627f-4a68-9071-5ab03891ed31",
"url": "https://regbase.jp/en/enforcement/yakkiho-ri-ben-lin-chuang-jian-cha-yao-xie-hui-unknown",
"company_name_original": "日本臨床検査薬協会",
"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": "linked_profile_without_source_identifier",
"method_label": "linked_profile_without_source_identifier",
"notes": "The linked profile has a Corporate Number, but the public disclosure does not contain that number and no unique independent NTA name/address match was found."
},
"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-ri-ben-lin-chuang-jian-cha-yao-xie-hui-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": "2026-04-27T12:01:53.108+00:00",
"translatedAt": "2026-05-01T09:43:12.017+00:00",
"evidenceCheckedAt": "2026-04-27T12:01:53.108+00:00",
"generatedAt": "2026-08-04T23:10:48.180Z"
},
"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.