Recently, China Food and Drug Administration has organized an overseas on-site inspection on imported medical devices and found that, both the Calcium Sulfate and Absorbable Artificial Bone Powder products of Biocomposites. Ltd were registered in China individually, but it is found on the scene that, both the two products were delivered to and marketed in China in the form of combination pack, with their inner packages containing syringe and water for injection that have never been registered in China, suggesting the products are inconsistent with the ones declared and registered and they are suspected of violating the relevant provisions in the Regulations for the Supervision and Administration of Medical Devices and the Administrative Measures for Medical Device Registration. To guarantee the safety of devices for public use and in accordance with the provisions in Article 55 of the Regulations for the Supervision and Administration of Medical Devices (Decree of the State Council of the PRC No. 680), China Food and Drug Administration has decided to suspend the import of calcium sulfate and absorbable artificial bone powder products from Biocomposites. Ltd in the form of combination pack and organize the investigation and handling of related cases and clues by law since this very day.

It is hereby announced.

China Food and Drug Administration

December 11, 2017