China to Amend Device Regs This Year, New GMP Compliance Rules Anticipated

May 10, 2012
China is expected to begin amending its current medical device rules this year, as part of its 12th five-year plan to update its drug and device regulations, according to a panel of China experts at the Food and Drug Law Institute’s annual conference in Washington, D.C. Near the forefront of the anticipated revisions are new good manufacturing practice (GMP) compliance rules, Chen Yang, a partner at Sidley Austin, said. The regulations represent a “huge task” for the Chinese government, at a time when it is also discouraging the creation of new manufacturing facilities, she said.
International Medical Device Regulatory Monitor