On November 4, FDA met with China’s General Administration of Customs (GACC) to discuss the facility registration requirements in Decree 248. FDA requested clarity on which firms are able to self-register and which firms must be recommended by the competent authority. To provide the requested clarification, GACC plans to publish guidance on which registration procedures apply to particular Harmonized Schedule (HS) codes. GACC stated that current trade will not be affected. The United States and China plan to continue discussions about implementing these new requirements.

GACC has launched the self-registration website for foreign firms that export to China. Firms may provide their FDA Establishment Identifier (FEI) as the identification or approval number for registration with China. Firms may look up their FEI numbers by name and address using the FEI Search Portal. Details on GACC’s website are found in the USDA/FAS GAIN Report Decree 248 Foreign Facilities Self-Registration Website Launched. The report includes GACC contact information for inquiries about the process.

FDA will continue to share new information about Decree 248 as it becomes available through this listserv.

Article source: FDA