On December 21, FDA update the information on China’s New Facility Registration Requirements.

The FDA has provided the General Administration of Customs of China (GACC) lists of U.S. establishments that sought to be recommended for registration in China via the FDA’s Export Listing Module (ELM). In its communication to GACC, the FDA requested that the GACC register these establishments without delay so these establishments could continue to export their goods after January 1, 2022. FDA provided this information to minimize any disruption in trade.

At the same time, the U.S. government continues to engage with Chinese officials to express concern about the nature of the requirements and gain clarity about how China will apply the new requirements to U.S. products. In particular, the United States is continuing to seek confirmation that competent authority recommendation is not a requirement for U.S. facilities to register with China. Given the ongoing lack of clarity, the United States is continuing to press China for a delay in implementation of these Decrees by at least 18 months.

The FDA will continue to work with its federal partners and share additional information as it becomes available. We encourage U.S. establishments to contact GACC or their importers in China with questions about registration under Decree 248.