With growing concerns of quality control in China, the U.S. will soon have access to records of Chinese manufacturers failing to comply with regulations. China’s State Food and Drug Administration (SFDA) and the US Department of Health and Human Services (HHS) issued a memorandum of understanding (MOU) with various initiatives to improve China’s medical device industry.
For foreign companies interested in sourcing their medical products and setting up partnerships, this MOU will hopefully help raise the quality of local Chinese medical device manufacturers. Under the MOU, China will certify the safety of specified exported medical devices and create product-tracking systems. The SFDA will also notify the US FDA if a facility does not meet inspection requirements or has its certification revoked. In addition, the SFDA plans to create a system certifying Chinese firms and products that meet US FDA standards.
Other China medical device related plans were developed in the 18th US-China Joint Commission on Commerce and Trade. For medical devices, China agreed to eliminate redundancies in testing and certification requirements for imported medical devices. China plans to implement a “one test, one fee” policy to establish a single conformity assessment system for medical device testing.
China has also agreed to suspend implementation of AQSIQ (General Administration of Quality Supervision, Inspection, and Quarantine) Decree 95, which would have increased testing and inspection redundancies focused specifically on imported medical devices.