China harmonization
This article was originally published in The Gray Sheet
Executive Summary
The Chinese State Drug Administration (SDA) will meet with two FDA officials and three industry representatives from U.S. and European device trade organizations at a Sept. 11-13 workshop in Kunming to help familiarize Chinese SDA officials with Global Harmonization Task Force quality systems regulations. Postmarket surveillance and use of standards are among other items on the agenda. Sponsored by the U.S. Department of Commerce, the workshop stems from an April meeting with SDA by the U.S. Joint Commission on Commerce and Trade/Medical & Pharmaceutical subgroup to China (1"The Gray Sheet" May 21, 2001, p. 8). Commerce hopes that the workshop will encourage China to harmonize, cutting barriers and stimulating medical device trade