The FDA is extending its tentacles deeper into China, which exported medical devices worth $3.5 billion to the U.S. in 2012, according to the U.S. Department of Commerce.
Reuters reports that the agency expects China to approve the visas of additional FDA staff "in the coming weeks and months," citing an FDA spokesperson. The agreement means the FDA will more than double in size in China, from 13 employees, including 5 Chinese members, to 33 employees, including 7 Chinese members, according to the Reuters article. Congress authorized the new hires in 2013, but they were delayed because the FDA could not obtain visas for the new employees.
The FDA's country director in China, Christopher Hickey, said that the agency's device arm, CDRH, cooperates with its Chinese regulatory counterpart, China FDA. "Experts from FDA's Center for Devices and Radiological Health now meet regularly with their counterparts from CFDA under the auspices of the International Medical Devices Regulatory Forum. These investments will pay long-term dividends for the American people: a stronger Chinese regulatory system can only strengthen FDA's efforts to promote and protect U.S. public health," he wrote on the FDA blog in April.
Several large med tech companies have significant manufacturing operations in China, whether due to acquisitions or organic growth. And the country boasts homegrown players with a U.S. presence, such as Mindray Medical, which recently announced the launch of the M9 ultrasound system in the U.S.
PharmAsia News reported in October that the FDA is preparing for the entry of Chinese-made, high-risk Class III devices into the U.S., and the additional staff will certainly help the agency in that effort, though the monitoring of drug safety figures to be high on the priority list as well. Ames Gross, president of consultancy Pacific Bridge Medical, previously told FierceMedicalDevices that the exportation of Class III medical devices from China to the U.S. is possible in the long run, but not likely in the near term due to quality issues of the China-made products.
The FDA has been pushing to resolve the visa issue since Congress authorized the new hires.
"Visa issues that arose with the Chinese government over new FDA staff assigned there were addressed during Vice President Joe Biden's visit to Beijing in December [2013], and FDA continues its work to post new staff in Beijing in the coming months," Hickey wrote in April.
The two countries came to a broader agreement over visas during President Obama's recent visit to China. Now, it is FDA Commissioner Margaret Hamburg's turn. During this week's tour of China she plans to focus on drug safety.
"The challenges we see in China mirror those we see in other countries with developing regulatory systems," Hickey wrote. "These issues include problems with data integrity, inadequate implementation of quality systems in manufacturing, and inconsistent regulatory oversight, among others."
- here's the Reuters' article
- here's the FDAVoice blog post