Morgan Lewis (JD Supra China)

China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on June 1, 2021.

President Trump’s Executive Order Addressing the Threat from Securities Investments that Finance Communist Chinese Military Companies (EO 13959) prohibits transactions by or on behalf of US persons in publicly traded securities of Chinese companies identified by the US government as “Communist Chinese military companies.”

China’s Ministry of Commerce (MOFCOM) published the Rules on Counteracting Unjustified Extraterritorial Application of Foreign Legislation and Other Measures (the Blocking Statutes) on January 9. The rules, which consist of only 16 articles, became effective upon publication.

Feedback on recent applications to the China Securities Regulatory Commission provides some clarity on what will be expected from foreign asset managers wishing to establish fund management companies in the Chinese domestic mutual fund market.

Long-awaited legislation in China—the Personal Information Protection Law of the People’s Republic of China—was released for public consultation on October 21. Once passed, the law will be the first designated personal information protection law in China.

The Chinese government has been actively promoting internet-based medicine in mainland China since 2014. On July 17, 2018, the National Health Committee (NHC) and the State Administration of Traditional Chinese Medicine jointly issued the three fundamental rules that formed the basic legal framework of China’s internet-based medicine...

While retailers in China have been permitted to reopen, required steps to do so include health and sanitation measures. Some local governments are also considering extending the weekend in order to stimulate consumption and promote economic recovery.

Companies that have been enrolling their Beijing employees in state social insurance schemes through third-party agencies need to rethink their employment model, as Beijing is cracking down on the legitimacy of such enrollment.

President Donald Trump signed a proclamation on May 29, 2020, temporarily suspending entry into the United States of certain Chinese nationals holding F-1 or J-1 status.

In this LawFlash, we outline the expense fraud scheme reported in a 2019 case involving the crime of illegal sale of “fapiaos,” examine some typical expense fraud schemes in China, and provide our practical takeaways with regard to preventing expense fraud.

Both individuals and higher education institutions could face criminal and civil liability if they are not in compliance with federal law in the administration of federal grants and expenditure of federal research dollars, as recent cases tied to simultaneous research in China show.

The new measure, which will come into effect on June 1, 2020, will potentially affect operators of critical information infrastructures as well as their domestic and overseas suppliers. Affected companies should now take preparatory steps, including conducting a self-assessment and reexamining their procurement agreements.

As the number of coronavirus (COVID-19) infections has diminished in the People’s Republic of China (PRC), everyday life has been evolving slowly to bring employers and employees closer to the pre-COVID-19 working environment. However, schools still remain closed (with no official date set for their reopening) and large public gatherings are still prohibited.

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and post-market compliance matters, as well as the specific provisions governing customized medical devices.

As employers in the People’s Republic of China have proceeded or attempted to resume operations since the end of the extended Spring Festival period in early February, they have faced various preapproval and filing requirements imposed by local governments based on several epidemic prevention and control measures implemented to control the spread of the 2019 Novel Coronavirus.

In the changing employment environment surrounding the current outbreak of the 2019 Novel Coronavirus (2019-nCoV) in the People’s Republic of China (PRC), salary payment standards are governed by local rules and emergency measures. This LawFlash provides a summary of the different standards as of February 3.

This Lawflash provides multinational companies with operations in the People’s Republic of China (PRC) with some guidance on how to handle the challenging employment issues during this time. The situation is fluid and rapidly changing, and this Lawflash provides insight based on select emergency measures issued through the evening of January 29, 2020.

The US–China trade deal signed on January 15 aims to strengthen intellectual property protection for US intellectual property holders.

The growth of automobile production and sales in China, particularly in the realm of alternative fuel vehicles (New Energy Vehicles or NEVs), has been nothing short of explosive, experiencing a nearly 1,000-fold increase between 2011 and 2018. The country now produces hundreds of thousands of these vehicles annually and the industry consequently has drawn intense interest from non-Chinese...

The Chinese government is encouraging greater participation in the state-sponsored social benefits schemes through legislative changes. These changes will impact multinational employers, with the most significant change taking effect on January 1, 2020.

China has recently made significant strides in amending its intellectual property (IP) laws in a manner that provides substantial benefits and protections for medtech IP owners. As of November 1, 2019, China has taken another step in changing several aspects of its patent examination guidelines, along with the amendments to its trademark, trade secret, and unfair competition law. This LawFlash...

In an effort to drive down medical costs, the PRC Ministry of Finance has announced it will audit 77 randomly selected drug makers in China in order to examine the companies’ costs and profits and determine the reasonableness of their drug pricing mechanisms.

The Administration for Market Regulation of Jing’an District in Shanghai (AMR) on May 7 announced an administrative penalty decision against the Shanghai branch of a multinational pharmaceutical company (the Branch) for speaking fees it paid to physicians. According to the decision, the AMR found that the speeches in question never actually occurred and that the “speaking fees” were actually...

China has long been criticized for having enacted various regulations allowing discriminatory technology licensing practices against foreign technology owners. These regulations restrict the ability of foreign technology owners to negotiate market-based terms for the transfer of technology into China, which effectively amounts to forced technology transfer to Chinese licensees in some cases. In...

The Amended Individual Income Tax Law has implications for both Chinese nationals and expatriates working in the People’s Republic of China. Notably, tax residency, and its accompanying individual income tax liability, will be more easily triggered as expatriates will be considered tax residents if they reside in China for 183 days or more in a calendar year. For an interim period, however,...

Under new rules effective January 1, 2019, Chinese tax authorities will now collect social insurance fees on the actual income paid to employees based on the monthly reporting of income for individual income tax filings. Sudden increases in collected amounts by the tax authorities are likely to trigger audits of employers by the authorities regarding underreporting of income and/or questions from

The right to privacy in China is generally recognized in the Constitution of the People’s Republic of China and Tort Liability Law. Over the past years, the Chinese government has continued to actively legislate into law a myriad of new regulations related to data privacy. With China’s Cybersecurity Law (CSL) and General Principles of Civil Law taking effect in 2017—which stipulate more stringent

Expanding on recent reforms allowing innovative pharmaceutical drugs to be approved on the basis of overseas clinical trial data, China’s National Medical Products Administration (NMPA) has created special channels for the approval of new pharmaceuticals subject to “urgent” clinical needs.

The Chinese Ministry of Public Security (MPS) on September 15, 2018, released the Provisions for the Supervision and Inspection of Network Security by Public Security Agencies, also known as “Circular 151.” This new regulation provides a legal basis and framework for wide-ranging authority for local law enforcement agencies (Public Security Bureau, or PSB) in China to enforce China’s...

Under recent Chinese banking regulations, which include the increased regulation of asset and wealth management products, licensed commercial banks must have prior approval and licensing to engage in the marketing and sale of wealth management products, both onshore and offshore. In light of the recent possible detainment of a commercial banker in Beijing, financial institutions that market and...