To help export enterprises to have a deep understanding of the recent changes of relevant US laws and regulations, China Association for Medical Devices Industry held a Communication Meeting between FDA and Export Enterprises at Suzhou on March 16, 2016.Over 200 representatives of various enterprises from all over the country attended the meeting.

Ms. Wang Huifang, a member of SAC/TC221 Quality Management and Corresponding General Aspects for Medical Devices, the first drafter of YY/T0316 and dafter of YY/T0287 was invited to attend the meeting and make a detailed introduction of the editorial thought and major alternation of ISO13485:2016.Ms. S. Leigh Verbois, principal expert and director of FDA office in China, Mr. Nicole Taylor Smith and MR. Wang Gang, assistant directors, Mr. Chiang Syin, deputy director of inspection affairs, Mr. William Sutton, secondments official of medical devices, and Ms. Wang Lixia, a medical officer, attended the meeting. William Sutton interpreted the UDI requirement for Class II medical devices to be implemented on September 24, 2016, and then the director S. Leigh Verbois, assistant director Nicole Taylor Smith, inspection affairs deputy director Chiang Syin and secondments official of medical devices William Sutton answered relevant questions raised by enterprises during earlier investigation. The attending enterprises had a face-to-face communication with experts on the current regulations and technical problems encountered when exporting to America.

Through this meeting, enterprises had a better understanding of the changes of new ISO13485 standard and the application of the standard, as well as the recent regulations on American medical devices and gained more confidence and competitiveness to run businesses abroad. The meeting won praises from the participants.