China Releases New Draft Rules on Overseas Audits

On December 28, 2017, the China Food and Drug Administration (CFDA) released draft regulations applying to the overseas development and production of drugs and medical devices for use in China. The CFDA has been expanding its overseas audits since starting its international inspection program in 2015. The latest proposed rules apply to Class II and III medical devices. They cover key audit processes including inspection coordination, collection of evidence and issue of the final report. The proposals specify that the audit team must notify manufacturers within 40 days if they find any violations. Companies would then have 40 days to submit a report to the CFDA on corrective actions.