Sino-German Workshop on Medical Device Safety
China
On 24 September 2019, the Federal Ministry for Economic Affairs and Energy (BMWi) and the National Medical Products Administration (NMPA) held a joint workshop on current regulatory topics for medical devices in Suzhou, China. As part of the Sino-German cooperation on Quality Infrastructure, the event provided a platform for dialogue and direct exchange between German authorities and industry representatives with Chinese regulators.
Main topic of the workshop was the ongoing establishment of Unique-Device-Identifier (UDI)-Systems in China and Europe. Further points of discussion were current regulatory reforms in Europe, specifically the implementation of the EU Medical Device Regulation (MDR) / In Vitro Diagnostics Regulation (IVDR) and potential impacts in China.
The workshop was chaired by Mr. Wang Lanming, Director General of NMPA and Mr. Thomas Triller, Consul at the Consulate General of the Federal Republic of Germany in Shanghai. Expert inputs were presented by representatives of NMPA, the National Institute for Food and Drug Control (NIFDC) on the Chinese side, and the German Medical Technology Association (BVMed) as well as GS1 on the German side.
Involving all relevant stakeholders into the dialogue and drawing on the expertise from the private sector is of central importance to building a regulatory system that achieves the delicate balance of providing fast access to safe and high-quality medical services for patients. Both sides therefore called on industry representative to continue to raise their concerns and ongoing topics of interest to be included into the ongoing bilateral dialogue on medical device safety between BMWi and NMPA.
The event was organised by the country component China of the Global Project Quality Infrastructure (GPQI), which is implemented by Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH on behalf of BMWi to support the Sino-German cooperation on quality infrastructure.