The State Council of China revised and issued the Regulations for the Supervision and Administration of Medical Devices on March 7, 2014.  The new regulations are going to take effect from June 1, 2014.  Previously, the old regulation defines Class III as the medical devices implanted into or pose potential risk to the human body -- Class III Medical Devices are those which are implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.  The new regulations apparently abandoned this human body-related classification.

On March 28, 2014, at the joint press conference of the State Food & Drug Administration and the Ministry of Public Securities, the concerned governmental official of the Ministry of Public Securities confirmed that China is going to set the Investigative Bureau on Violations of Food and Drug Laws (食品药品违法侦查局) to protect the “safety at the tip of tongues” (舌尖上的安全).  The police force on food and drug safety will be focusing on cracking down on the manufacturing and sale of fake food and drug.    

Blacklisting is not contagious between parent and subsidiary companies.  In other words, if a parent company is blacklisted, its subsidiary company would not be blacklisted just because its parent company being blacklisted, and vice versa.  The businesses that manufacture, distribute and sell pharmaceuticals and medical devices should consider dispersing their compliance risks – do not use one business to sell all of their products.  In other words, don’t put all of the medical “eggs” into one blacklisted “basket”.

It is a crime in China, specifically the crime of giving bribes to a unit, to give the property or money (such as giving rebates) to xiaojinku (i.e., coffer) of SOEs.  The crime is unique compared with the offences under the FCPA.  For example, the FCPA prohibits payments to foreign officials, not to foreign governments (Page 20 of A Resource Guide to the U.S. Foreign Corrupt Practices Act).  However, with the mentality under the FCPA to make some payments (such as rebates) to Chinese SOEs such as Chinese State-owned hospitals (which are regarded as foreign governments under the FCPA), a business could find themselves meeting some troubles unexpectedly, and the troubles could be as bad as criminal implication.

New Provisional Regulations on Labour Dispatch were issued by the Ministry of Human Resources and Social Security on 24 January 2014. Labour dispatch practices, which involve a business choosing to outsource workers from third-party dispatch agencies rather than directly employing the workers, are already regulated by China’s Labour Contract Law. According to the new regulations, after an initial grace period dispatched workers must not comprise more than 10 per cent of a company’s total workforce.

To implement this year’s anti-graft plans, Premier Li produced six specific requests.  The first request is to carry out the on-going regulations and rules such as hammering against patchy action on government buildings, head counts and conferences.  Li called on auditors and supervisors to be "brave enough to crack the hard nuts" and investigate violation cases "deeply, thoroughly and concretely."