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Highlights on the New Drug Recall Regulation of 2022

WebArticle 15 of the 2022 Measures: The MAH shall apply to release the recall information on the website of the provincial MPA. Article 16 of the 2022 Measures: Time limit: within 3 …

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Top 10 Q&As on 2023 China Healthcare Anti-Corruption Initiatives

WebThe key issues of anti-corruption compliance in the healthcare industry cover the whole industry chain. We have summarized a corresponding compliance risk map as …

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Han Kun Newsletter

Web1 www.hankunlaw.com 1. Top 10 Q&As on 2023 China Healthcare Anti-Corruption Initiatives Authors: Aaron GU丨Sophie SHI丨Pengfei YOU丨Duzhiyun ZHENG丨Fengqi …

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the Healthcare Law Review

Webv PREFACE The sixth edition of The Healthcare Law Review covers six new jurisdictions and a total of 17 jurisdictions from Europe, North and South America and Asia. All …

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Education Opening-up: Examining Opinions of the Ministry of …

Web4 www.hankunlaw.com reform and opening-up in China. Among these reform measures, the most important is the revisions to the Regulations on Chinese-foreign Joint Running …

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Top 10 Q&As on 2023 China Healthcare Anti-Corruption …

WebOn May 11, 14 national ministries and commissions jointly issued the Key Points of Work on Rectifying Misconduct in the Fields of Medical Product Purchase and Distribution and …

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Healthcare: Medical Devices 2023

WebCHINA Trends and developmenTs Contributed by: Yang (Aaron) Gu, Pengfei You, Duzhiyun Zheng and Fengqi Yu, Han Kun Law Offices 4 CHAC Current Developments in …

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How Digital Therapeutics (DTx) Products are Regulated in …

WebFavourable policies. Local governments across China have introduced policies to support the DTx industry, most of which target only the DTx products developed and registered …

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Highlights on the New Drug Recall Regulation of 2022

Web1 www.hankunlaw.com Highlights on the New Drug Recall Regulation of 2022 Authors: Aaron GU丨Ruohong YAO丨Pengfei YOU丨Duzhiyun ZHENG1 On October 26, 2022, …

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comparative analysis from top-ranked lawyers Life Sciences …

WebLife Sciences 2022 practiceguides.chambers.com Definitive global law guides offering comparative analysis from top-ranked lawyers China: Trends & Developments

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Han Kun represents Biomerieux in establishing strategic …

WebHan Kun represents Biomerieux in establishing strategic cooperation with Accunome. 2022-12-28. In December 2022, Biomerieux and Jiaxing Accunome …

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Highlights on New Draft Rules of Drug Administration

WebOn May 9, 2022, National Medical Products Administration (NMPA) issued for public comments a draft revision (the “Draft Revision”) to the Regulations for the …

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New LDT Pilot Regulations Key Takeaways

Web1. In terms of personnel: The principal responsible person of the pilot hospital is fully responsible for the R&D, production, and use of in-house made reagents; …

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Regulation of foreign-invested medical institutions in China

WebReproduced from Practical Law, with the permission of the publishers. For further information visit uk.practicallaw.thomsonreuters.com or call +44 20 7542 6664.

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CAC Releases Guidelines for China SCC Filings

WebAuthors: Kevin DUAN丨Kemeng CAI丨Lian XU On May 30, 2023, the Cyberspace Administration of China (the “CAC”) released the Guidelines for Filing Standard Contract …

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New LDT Pilot Regulations Key Takeaways

Web1. In terms of personnel: The principal responsible person of the pilot hospital is fully responsible for the R&D, production, and use of in-house made reagents; Staffing with …

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Highlights on HGR Regulation Implementation Rules

WebIn Article 2 of the Implementation Rules, human genetic resources information refers to data and other information such as human genes and genome data generated from the use of …

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医疗机构监管 — 医疗机构管理条例(2022年修订)新旧对比

Web第一章 总则. 第一条 为了加强对医疗机构的管理,促进医疗卫生事业的发展,保障公民健康,制定本条例。. 第二条 本条例适用于从事疾病诊断、治疗活动的医院、卫生院、疗养院、门 …

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