BSI China supported by the Global Medical Device team held their first Medical Device Forum on 16th - 17th May 2013 in Shanghai. David Horlock Managing director Asia Pacific and Dr Yi Min Goa Managing Director BSI China represented senior BSI management by opening the meeting on the Thursday morning. Their primary message was the strength and depth of BSI as a Global provider of Standards, Assurance and Training, with a specific focus on BSI’s world class position in the Medical Device regulatory arena as the recognised leading global CAB. The event announces BSI’s significant investment in the region and in the rapidly growing and increasingly important Chinese Medical Device Manufacturing sector.
The programme included speakers from the Global BSI Medical Devices team, BSI Taiwan, BSI China and BSI Japan as well as presentations by existing BSI clients. The delegates included Regulators, Development Engineers and Product Designers from Medical Device manufacturers who were joined by academics and Senior Government representatives from the China Food and Drug Administration (CFDA – formerly SFDA).
The combination of presentations and frequent vibrant Q&A sessions covered three key areas of great interest to the more than 150 delegates on each of the two days. The keynote topics were current EU regulatory market access requirements, emerging EU requirements and other geographical medical device regulatory systems including China (CFDA), US (FDA), Canada (CMDCAS) and Taiwan (TCP).
This very successful event provided delegates with a real insight into BSI’s global presence and ability to partner with Chinese Medical Device Industry in providing high quality expert led conformity assessments in both China and the wider Asia Pacific region. It also clearly demonstrated BSI’s commitment and capability to provide expert insight into Global Medical Device regulations both current and emerging.
Gary Slack – Global Director Medical Devices.