03 September 2019
China Expands Medical Devices Market Authorization Holder Pilot Project to 21 Provinces/Municipalities
www.twobirds.com/en/news/articles/2019/global/china-expands-medical-devices-market-authorization-holder-pilot-project-to-21-provinces

On 1 August 2019, the National Medical Products Administration ("NMPA") issued a notice to extend the pilot project of medical device registrant system (GUO YAO JIAN XIE ZHU (2019) No.33) ("Notice") to 21 ...

15 December 2017
Software as medical device - CJEU applies broad interpretation and clarifies that the software's purpose is decisive for classification
www.twobirds.com/en/news/articles/2017/global/software-as-medical-device

19 September 2016
A-G Sharpston considers Notified Bodies liable to patients for failure to fulfill their duties arising from EU product safety rules
www.twobirds.com/en/news/articles/2016/global/ag-sharpston-considers-notified-bodies-liable-to-patients-for-failure-to-fulfill-their-duties

31 December 2020
Medical Device UDI System Goes Live in China on 1 January 2021
www.twobirds.com/en/news/articles/2020/china/medical-device-udi-system-goes-live-in-china-on-1-january-2021

Those in the medical device industry will be familiar with the Unique Device Identification (“UDI”) system for medical devices. While it has been a global discussion piece for many years, the timeline for implementation ...

08 February 2017
The Changing Face of Medical Devices and In Vitro Diagnostic Medical Devices: White Paper on the New Regulations
www.twobirds.com/en/news/articles/2017/global/medical-devices-white-paper

18 January 2021
Brexit: Medical devices implications
www.twobirds.com/en/news/articles/2016/uk/brexit-medical-devices-implications

The UK exits the EU on 31st January 2020. By virtue of the transition period in the Withdrawal Agreement, EU law will continue to apply in and in relation to the UK only until the 31st December 2020.

20 June 2019
China to accelerate the development of "Smart Supervision System" for drug and medical devices
www.twobirds.com/en/news/articles/2019/global/china-to-accelerate-the-development-of-smart-supervision-system-for-drug-and-medical-devices

The NMPA issued the Drug Smart Supervision Plan aiming to deepen the development of a drug supervision system embracing modern information technologies such as cloud computing, big data, and "Internet+" technologies.

23 April 2020
COVID-19: Our series of regulatory legislation trackers for the Life Sciences & Healthcare industry
www.twobirds.com/en/news/articles/2020/global/covid-19-our-series-of-regulatory-legislation-trackers-for-the-life-sciences-and-healthcare-industry

COVID-19 presents an unprecedented challenge to the global life sciences industry. Members of our International Life Sciences & Healthcare team, lawyers who have a wealth of hands-on experience and strong relationships ...

22 August 2017
How could the current cybersecurity consultation affect the Life Sciences & Healthcare sector?
www.twobirds.com/en/news/articles/2017/uk/how-could-the-current-cybersecurity-consultation-affect-the-life-sciences-and-healthcare-sector

The UK Government has repeatedly declared its commitment to defending the country against cyber threats. As part of that commitment a five-year National Cyber Security Strategy (NCSS) was announced in November 2016, ...