Enforcement record

承認 disclosure naming 日本ストライカー株式会社

日本ストライカー株式会社 (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 disclosure30 August 2019

Action type

承認

Law

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

Authority

Ministry of Health, Labour and Welfare

Action date

30 August 2019

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-OTHER-RI-BEN-SUTO-202608041727
Generated at: 5 August 2026 at 02:27
Record URL: https://regbase.jp/en/enforcement/other-ri-ben-sutoraika-20190830

1. Review Summary

Disclosure name	日本ストライカー株式会社	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	30 August 2019	Authority	Ministry of Health, Labour and Welfare
Law	Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices	Action type	承認
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	日本ストライカー株式会社

3. Enforcement Record

Target name in disclosure	日本ストライカー株式会社
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 / 承認
Action / announcement date	Action: 30 August 2019 / Announcement: 9 April 2026
English summary	The Ministry of Health, Labour and Welfare established a legal framework in 2017 to create a system for the proper collection, disassembly, cleaning, parts replacement, reassembly, sterilization, and other processing (re-manufacturing) of used single-use medical devices (SUD) by medical device manufacturers under their responsibility, to enable their reuse.
Original Japanese text	厚生労働省では、使用済みの単回使用医療機器（一回限り使用できることとされている医療機器。SUD）を医療機器製造販売業者がその責任のもとで適切に収集し、分解、洗浄、部品交換、再組立て、滅菌等の処理を行い、再び使用できるようにすること（「再製造」）に関する制度を創設するための法令整備を平成29 年に行いました。
Official source	https://www.mhlw.go.jp/stf/newpage_06417.html
Source archive	https://kiroku.today/a/51a1d3c929hgepzl
Extraction / evidence timestamps	Extracted: 25 April 2026 at 09:18 / Evidence checked: 25 April 2026 at 09:18 / Archive captured: 12 July 2026 at 16:13

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 日本ストライカー株式会社

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Preserved evidence by Kiroku

Review the preserved source for 日本ストライカー株式会社

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Open preserved source and evidence pack

For developers: JSON integration details

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/api/v1/enforcements?company=%E6%97%A5%E6%9C%AC%E3%82%B9%E3%83%88%E3%83%A9%E3%82%A4%E3%82%AB%E3%83%BC%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Open JSON Specs

Action summary

Company: 日本ストライカー株式会社Japanese only
Original: 日本ストライカー株式会社
Governing law: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
医薬品医療機器等法
Action type: 承認
承認
Action date: 30 August 2019
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

The Ministry of Health, Labour and Welfare established a legal framework in 2017 to create a system for the proper collection, disassembly, cleaning, parts replacement, reassembly, sterilization, and other processing (re-manufacturing) of used single-use medical devices (SUD) by medical device manufacturers under their responsibility, to enable their reuse.

Show original Japanese text

厚生労働省では、使用済みの単回使用医療機器（一回限り使用できることとされている医療機器。SUD）を医療機器製造販売業者がその責任のもとで適切に収集し、分解、洗浄、部品交換、再組立て、滅菌等の処理を行い、再び使用できるようにすること（「再製造」）に関する制度を創設するための法令整備を平成29 年に行いました。

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

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: 2026-04-25T00:18:41.509+00:00
Evidence checked: 2026-04-25T00:18:41.509+00:00
Archive captured: 2026-07-12T07:13:11.670269+00:00

Show audit JSON

{
  "record": {
    "id": "4888d49e-2600-47e5-b0bc-bcaa75d5ac58",
    "url": "https://regbase.jp/en/enforcement/other-ri-ben-sutoraika-20190830",
    "company_name_original": "日本ストライカー株式会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "医薬品医療機器等法",
      "en": "Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices"
    },
    "action_type": {
      "ja": "承認",
      "en": "承認"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "unresolved",
    "confidence": 85,
    "method": "nta_strict_name_nationally_unique",
    "method_label": "nta_strict_name_nationally_unique",
    "notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (日本ストライカー株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Japanese regulatory disclosure under Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-ri-ben-sutoraika-20190830",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_06417.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/51a1d3c929hgepzl",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_06417.html",
    "archiveCapturedAt": "2026-07-12T07:13:11.670269+00:00",
    "extractedAt": "2026-04-25T00:18:41.509+00:00",
    "translatedAt": "2026-05-01T07:07:24.701+00:00",
    "evidenceCheckedAt": "2026-04-25T00:18:41.509+00:00",
    "generatedAt": "2026-08-04T17:27:22.938Z"
  },
  "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.