China is the second largest market for pharmaceuticals in the world with the market estimated to be at $83 billion in 2013. Exports of U.S medical devices to China reached over $3 billion in 2014. Cutting red tape in China’s medical device approval process would allow better patient outcomes and more exports to China’s largest growth market.
Secretary of Commerce Penny Pritzker and U.S Trade Representative Michael Froman led a U.S delegation in discussions with Vice Premier Wang Yang and other Chinese government officials in the 26th session of the U.S China Joint Commission on Commerce and Trade (JCCT) held November 21-23 in Guangzhou, China. Secretary of Agriculture Tom Vilsack and U.S Ambassador to China Max Baucus also participated in this year’s JCCT.
Pharmaceutical and Medical Devices was just one of the topics under discussion. The U.S and China have achieved concrete outcomes on implementing mutually agreed upon goals to eliminate drug and medical device application backlogs and agree that the countries need to work to improve the time it takes to make these products available to Chinese patients
Steps that need to be taken include publishing annual performance reports, expanding clinical trial exemptions for medical devices, enhancing pre-submission consultation opportunities for medical devices applicants plus publishing relevant reform measures to ensure transparency.
China also agreed that imported medical devices will be treated the same as domestically produced medical devices. These outcomes on pharmaceuticals and medical devices pave the way for significant increases in U.S exports in healthcare which is a key sector for future growth in China as the population ages and the economy matures.
China is currently refining mechanisms to communicate with registration applicants. For innovative medical devices, the China Food and Drug Administration (CFDA) will appoint personnel to evaluate and to provide guidance to the applicant. For other types of medical device registration applications, relevant department of the CFDA will conduct weekly group consultations for applicants.
In accordance with China’s medical device regulatory legal framework, China agrees that in terms of market access, they will give imported medical devices the same treatment as devices manufactured or developed domestically.