19 Feb, 2024 FDA’s new Quality Management System Regulation is here: Key takeaways for device companies in US, EU, and China By Bethany Hills Christopher Mikson Perham Gorji Jae Kim Adam Donat Marco de Morpurgo Ting Xiao +4 more... Show less On January 21, 2024, the FDA issued a final rule amending its Quality System (QS) regulations under 21 CFR Part 820, which addresses...
10 Nov, 2023 Implementation Rules of Human Genetic Resource Regulations—what it entails for life sciences clients in China By Ting Xiao Carolyn Bigg On June 1, 2023, China’s Ministry of Science and Technology (the “MOST”) issued the Implementation Rules of Administrative Regulations on...
04 May, 2021 New medical device regulations in China likely to lead to increased regulatory enforcement By Sammy Fang Ting Xiao Han Liang The Chinese State Council has passed the eagerly anticipated revisions to the PRC’s Regulations for Supervision and Administration of...
22 Apr, 2021 China’s Revised Regulations on Medical Devices: Good News for Industry Stakeholders? By Horace Lam William Fisher Ting Xiao On 9 February 2021, the PRC State Council issued the revised PRC Regulations on the Supervision and Administration of Medical Devices...
21 Oct, 2020 China signs off on PRC Biosecurity Law: What this means for industry players in China? By Ting Xiao William Fisher Horace Lam On 17 October 2020, the Standing Committee of the PRC National People’s Congress (“NPC”) passed the PRC Biosecurity Law, which will...