After two years of public consultation and two readings at the National People’s Congress, the first amendment to the Anti-Monopoly Law of the People’s Republic of China (PRC) has been promulgated under the spirit of...more
As China enhances its cybersecurity and data protection regime, the processing of personal information, and in particular the information of customers and employees, has come into focus under the Personal Information...more
Multinational entities with operations in or having business with the People’s Republic of China (PRC) should take note of the PRC’s new Personal Information Protection Law (PIPL), which took effect on 1 November 2021 and is...more
The Personal Information Protection Law (PIPL), which is considered the first comprehensive law on personal information protection in People’s Republic of China (PRC or China), came into effect on 1 November 2021. Prior to...more
On 30 July 2021, the State Council promulgated the Regulations on the Security Protection of Critical Information Infrastructure (the Regulation), which took effect on 1 September 2021. This Regulation dovetails with the...more
On 18 March 2021, the State Council of China announced certain amendments (the 2021 Amendment) to the Regulation on the Supervision and Administration of Medical Devices (the Medical Device Regulation). The 2021 Amendment...more
On 10 June 2021, the Standing Committee of the National People’s Congress of China (NPCSC) approved the enactment of Data Security Law (the DSL) of the People’s Republic of China (PRC), which will take effect on 1 September...more
This article reveals the mechanics of a growing pilot program for registration of Class II and Class III medical devices to be contract manufactured in China that has gained significant recognition across China over the past...more
On October 17, 2020, the Standing Committee of the National People’s Congress of China passed and adopted the Export Control Law of China (the ECL), which took effect on December 1, 2020. ...more
The medical device industry in China is highly-regulated and China adopts a “pre-market” recordation or approval system for medical devices. Before any medical device can be manufactured, imported, distributed, or sold in...more