{"data":[{"id":"b068d1d7-f1f3-4d88-b25e-736ca8fd563c","company_name":"米国医療機器・IVD工業会","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["要望"],"regional_record_count":1,"source_document_count":1,"law_name":"不明","action_type":"要望","action_date":"2024-10-07","announcement_date":"2026-04-20","violation_summary":"米国FDAにて承認された品目のうち、日本で突き合わせた結果、72％が未承認ではないかということになりました。そのうち、切り口を変えると、日本法人がない企業の場合は79％、日本法人がある場合は大分下がって51％という結果でございました。","violation_summary_en":"Among the items approved by the U.S. FDA, it was found that 72% are potentially unapproved in Japan based on cross-referencing. When changing the perspective, 79% of companies without a Japanese subsidiary are potentially unapproved, whereas for companies with a Japanese subsidiary, the percentage drops to 51%.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"linked_profile_without_source_identifier","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_45374.html","url":"https://regbase.jp/enforcement/other-mi-guo-yi-liao-ji-qi-ivdgong-ye-hui-20241007"},{"id":"f75f7d30-5934-4af3-a444-7644251cfea0","company_name":"日本赤十字社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["行政指導"],"regional_record_count":1,"source_document_count":1,"law_name":"不明","action_type":"行政指導","action_date":"2023-07-25","announcement_date":"2026-04-28","violation_summary":"秋篠宮皇嗣妃殿下が、新型コロナウイルス感染症に感染されたことが確認されたため、大会への御臨席をお取りやめになります。","violation_summary_en":"Princess Akishino has canceled her attendance at the event due to confirmation of her infection with COVID-19.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_34357.html","url":"https://regbase.jp/enforcement/other-ri-ben-chi-shi-zi-she-20230725"},{"id":"d54f70c6-b6ca-45a7-94a4-66dd4d1de1a8","company_name":"欧州ビジネス協会","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["行政指導"],"regional_record_count":1,"source_document_count":1,"law_name":"不明","action_type":"行政指導","action_date":"2022-10-18","announcement_date":"2026-04-14","violation_summary":"UDI施行に向けた準備、国際整合、リファレンスカントリー化、欧米での上市優先の課題について意見を述べている。","violation_summary_en":"Expresses opinions on preparations for UDI implementation, international harmonization, becoming a reference country, and prioritizing market launch in Europe and the United States.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_28612.html","url":"https://regbase.jp/enforcement/other-ou-zhou-bizinesuxie-hui-20221018"},{"id":"71617d18-62b5-4993-82fe-22da1ab7ddd2","company_name":"米国医療機器・IVD工業会","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["行政指導"],"regional_record_count":1,"source_document_count":1,"law_name":"不明","action_type":"行政指導","action_date":"2022-10-18","announcement_date":"2026-04-14","violation_summary":"審査の迅速化、国際整合、リファレンスカントリー化、グローバル展開の促進について意見を述べている。","violation_summary_en":"Expresses opinions on speeding up review processes, international harmonization, reference country designation, and promotion of global expansion.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"linked_profile_without_source_identifier","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_28612.html","url":"https://regbase.jp/enforcement/other-mi-guo-yi-liao-ji-qi-ivdgong-ye-hui-20221018"},{"id":"039d4380-3fec-4bd3-89ee-0fe53838e3a6","company_name":"日本臨床検査薬協会","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["行政指導"],"regional_record_count":1,"source_document_count":1,"law_name":"不明","action_type":"行政指導","action_date":"2022-10-18","announcement_date":"2026-04-14","violation_summary":"コロナ検査薬のOTC化推進、承認区分の見直し、検査薬の適正使用と情報提供の強化について提案している。","violation_summary_en":"Proposes the promotion of OTC status for COVID-19 test kits, a review of approval classifications, and the strengthening of proper use and information provision for test kits.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"linked_profile_without_source_identifier","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_28612.html","url":"https://regbase.jp/enforcement/other-ri-ben-lin-chuang-jian-cha-yao-xie-hui-20221018"},{"id":"b3292f0a-ab88-440c-9c14-87e70fb3cac5","company_name":"日本医療機器産業連合会","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["行政指導"],"regional_record_count":1,"source_document_count":1,"law_name":"不明","action_type":"行政指導","action_date":"2022-10-18","announcement_date":"2026-04-14","violation_summary":"規制の国際調和やリファレンスカントリー化、規制制度の見直し、デジタル化推進、医療データの利活用促進、規制制度の長期的な展望について提言している。","violation_summary_en":"It makes recommendations on international harmonization of regulations, becoming a reference country, reviewing regulatory systems, promoting digitalization, facilitating the use of medical data, and long-term prospects of regulatory systems.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":25,"method":"normalized_name_multiple_company_candidates","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_28612.html","url":"https://regbase.jp/enforcement/other-ri-ben-yi-liao-ji-qi-chan-ye-lian-he-hui-20221018"},{"id":"d1e3a1a5-b8a3-4b3f-a0d2-d9021103f3b8","company_name":"フィリピン食品医薬品局","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["行政指導"],"regional_record_count":1,"source_document_count":1,"law_name":"不明","action_type":"行政指導","action_date":"2022-06-30","announcement_date":"2026-04-21","violation_summary":"フィリピンが日本を医薬品簡略審査の対象国に指定しました","violation_summary_en":"The Philippines designated Japan as a country subject to simplified review for pharmaceuticals.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"extracted_japanese_name","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_26556.html","url":"https://regbase.jp/enforcement/other-huiripinshi-pin-yi-yao-pin-ju-20220630"},{"id":"87153303-c56c-491a-a969-69124d78496a","company_name":"日本赤十字社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["行政指導"],"regional_record_count":1,"source_document_count":1,"law_name":"不明","action_type":"行政指導","action_date":"2021-08-31","announcement_date":"2026-04-26","violation_summary":"第57回献血運動推進全国大会の中止についてお知らせします","violation_summary_en":"Notice of cancellation of the 57th National Blood Donation Campaign Promotion Conference","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_20673.html","url":"https://regbase.jp/enforcement/other-ri-ben-chi-shi-zi-she-20210831"},{"id":"9964391f-9201-4a65-8132-d1dde93c064c","company_name":"米国医療機器・IVD工業会","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["勧告"],"regional_record_count":1,"source_document_count":1,"law_name":"不明","action_type":"勧告","action_date":"2021-08-27","announcement_date":"2026-04-27","violation_summary":"国際整合やリファレンスカントリー化、プログラム医療機器の課題と要望、働き方改革とITシステム活用についての取組を説明。","violation_summary_en":"Explanation of efforts related to international harmonization, reference country designation, challenges and requests for programmable medical devices, work style reform, and utilization of IT systems.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":60,"method":"linked_profile_without_source_identifier","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_21919.html","url":"https://regbase.jp/enforcement/other-mi-guo-yi-liao-ji-qi-ivdgong-ye-hui-20210827"},{"id":"f38c5ccb-b31b-4cce-bd78-59f57eac0cdb","company_name":"日本医療機器産業連合会","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["勧告"],"regional_record_count":1,"source_document_count":1,"law_name":"不明","action_type":"勧告","action_date":"2021-08-27","announcement_date":"2026-04-27","violation_summary":"医療機器の規制や働き方改革、デジタル化推進に関する提言を行い、制度の効率化や医療安全の向上を目指す内容を説明。","violation_summary_en":"Provides recommendations on medical device regulations, work style reforms, and digitalization promotion, aiming to improve system efficiency and medical safety.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":25,"method":"normalized_name_multiple_company_candidates","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_21919.html","url":"https://regbase.jp/enforcement/other-ri-ben-yi-liao-ji-qi-chan-ye-lian-he-hui-20210827"}],"meta":{"query":null,"corporate_number":null,"law":"不明","authority":null,"action_type":null,"count":10,"api_docs":"https://regbase.jp/api-docs","openapi_schema":"https://regbase.jp/api/openapi.json","llms":"https://regbase.jp/llms.txt","usage_note":"Use RegBase for targeted public-source screening of Japanese companies and enforcement records. Absence of returned records is not a clearance, legal opinion, sanctions result, or credit decision.","rate_limit":{"limit":10,"window_seconds":60,"remaining":6,"reset_at":"2026-08-06T15:56:24.087Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":267,"reset_at":"2026-08-07T15:55:24.087Z"}}}