China--A vast nation...
China Agrees to Harmonize Device Standards; Streamline Product Registration
April 28, 2009
A recent meeting of the US-China Joint Commission on Commerce and Trade's (JCCT)
Pharmaceuticals and Medical Devices subgroup, proved most fruitful, AdvaMed said.
Officials at the U.S. Department of Commerce and China's State Food and Drug Administration (SFDA), agreed to harmonize their standards for medical devices now being developed, so that China can become a more trusted--and formidable--player in the medtech sector.
The two countries also discussed ways to streamline China's device registration process. Currently, U.S. device-makers doing business in China say the process is extremely cumbersome and product registrations are not expedited.
China's SFDA delegates also explained their country's new "adverse event" reporting regulation and pledged to work with AdvaMed member companies to make sure SFDA has sufficient regulatory oversight.
Following the meeting, at the request of the SFDA, AdvaMed arranged visits for the SFDA officials to Johnson & Johnson, Covidien, Boston Scientific, and Philips Healthcare, to show Chinese device makers the wide range of products produced by U.S. companies.
The two countries will hold a follow-up workshop in Beijing in June.
"We warmly welcome the accomplishments of these talks and look forward to further cooperation with the China State Food and Drug Administration as China continues to modernize its regulatory structure for medical devices," said Stephen J. Ubl, president and CEO of AdvaMed.
The U.S.-China JCCT is a cabinet-level dialogue that meets once a year and has subgroups that focus on a variety of industrial sectors.
Its Pharmaceuticals and Medical Devices Subgroup meets once a year and two separate task forces on pharmaceuticals and medical devices meet twice a year.