To prevent Bovine Spongiform Encephalopathy (BSE) entering and spreading in China through the use of medical devices, the State Food and Drug Administration (SFDA) issued an announcement on August 2, 2006, which specified the application acceptance and the registration of medical devices that contain materials from bovine or ovine sources which direct or indirect contact with human body and the registration of in vitro diagnostic reagents.

According to the announcement, relevant enterprises or their agencies should self-examine their products sold in China and the medical devices that, according to the announcement, are refused registration should be recalled before December 31, 2006.

For those already registered products which newly become refused registration products because they are from countries or regions where BSE is newly found, their registration certificates shall automatically become invalid and the products can not continue to be sold or used in China.

As of the date on which the announcement was issued, The Announcement Regarding Banning the Imports and Sales of Medical Devices Containing Bovine and Ovine Materials From Countries or Regions Where Bovine Spongiform Encephalopathy (BSE) Has Been Found issued on March 22, 2002 shall be abrogated simultaneously.