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Covington & Burling LLP | United Kingdom | 20 Mar 2023
UK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital Technologies as…
PLMJ | European Union | 14 Dec 2022
Extension of the transaction period of the MDR
The European Commission has announced its intention to propose amendments to Regulation (EU) 2017/745 of the European Parliament and of the Council…
Hogan Lovells | USA | 11 Oct 2022
FDA to regulate more AI & software tools as devices, guidance indicates
In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision…
Zhong Lun Law Firm | China | 29 Sep 2022
人工智能（AI）医疗器械行业常见合规问题面面观
由于新冠疫情爆发，医疗智慧化和远程医疗建设兴起，特别是人工智能（AI）医疗进入爆发期。多方资本纷纷入局，以推动人工智能（AI）医…
Hogan Lovells | USA | 23 Sep 2022
Medical device 510(k) submissions must be electronic by October 2023, FDA says
The U.S. Food and Drug Administration (FDA) has finalized its guidance “Electronic Submission Template for Medical Device 510(k) Submissions,” which…
Zhong Lun Law Firm | China | 23 Sep 2022
New Provisions for the Sale of Medical Devices in China
With the rapid development of China’s medical device industry, the Measures on Supervision and Administration of Business Operations of Medical…
Zhong Lun Law Firm | China | 16 Aug 2022
医疗器械经营监管的“放”与“收”——《医疗器械经营监督管理办法》的重大修订解读
近年来，我国医疗器械产业发展迅速，不断释放新的市场活力，相应的监管政策也逐渐渗透入医疗器械的全部生命周期。作为医疗器械从…
Osborne Clarke | European Union, United Kingdom | 28 Jul 2022
Products | Regulatory Outlook July 2022
On 29 June, the European Commission published an updated version of the "Blue Guide" on the implementation of EU product rules. The guide was last…
Oh-Ebashi LPC & Partners | China | 26 Jul 2022
中国ライフサイエンス・ヘルスケアの法務 第11回 ～医療機器監督管理条例改正～
中国における医療機器関連規制については、2020年12月に基本 法である医療機器監督管理条例が改正され（2020年12月21日改正、 2021年6月1…
Osborne Clarke | European Union, United Kingdom | 22 Jul 2022
The UK medical devices regime and the impact of the Northern Ireland Protocol
In the EU, the Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices…
