Beginning October 1, 2012, China’s State Food and Drug Administration (SFDA), including its provincial counterparts, will implement a nationwide information disclosure system called the Drug Safety Blacklist (“Blacklist”), which includes medical device products as well. According to the Tentative Rules on Medical Safety Blacklist (Circular No [2012] 219) (“Circular”) issued by SFDA on August 13, 2012, companies and “responsible persons” will be put on the Blacklist under the following circumstances:

  1. Revocation of Drug Approval or Drug Manufacturing license due to manufacturing or sale of counterfeit or substandard drugs;
  2. Revocation of Medical Device Production/Distribution License due to manufacturing or sale of unapproved or substandard products;
  3. Provision of falsified materials or concealing information in applying for administrative approval;
  4. Engaging in other improper conduct (fraud, bribery) in obtaining relevant licenses, approval documents or qualifications;
  5. Obstructing investigations by regulatory agencies;
  6. Criminal conviction under drug or device related laws;
  7. Serious quality or safety events caused by other violations of drug/device laws or other intentional violations with serious consequences.

In general, companies will be blacklisted for 2 years unless their specific violations mandate a different blacklist period. The Blacklist will affect future dealings with these blacklisted companies and individuals in terms of granting regulatory approvals or licenses. The public will have access to such information.