Leaders of the Provincial Drug Administration and Review Experts Visit the Designated Service Site in Hangzhou Bay New Area

On February 2, 2018, at the invitation of the Hangzhou Bay New Area and Linfeng Bio, a delegation of six—led by Dai Guiping, Deputy Director of the Medical Device Division of the Zhejiang Provincial Food and Drug Administration, and Zhen Hui, Deputy Director of the Medical Device Review Center, along with other provincial bureau leaders and review experts—and Hu Xia from the Medical Device Division of the Ningbo Municipal Market Supervision Administration, visited the Hangzhou Bay New Area. The delegation conducted on-site consulting services and research on medical devices at the Linfeng Medical Technology Industrial Park and toured several medical device manufacturing enterprises within the park, offering guidance and support.

The meeting was chaired by Mr. Lü Shiwen, General Manager and head of Linfeng Group, with on-site Q&A sessions conducted by leaders and experts from the Provincial Drug Administration. In addition to representatives from relevant enterprises within the Linfeng Industrial Park, all representatives from medical device companies in the Hangzhou Bay New Area also attended and participated in the event.

During the meeting, representatives from participating companies actively voiced their concerns and raised nearly 30 questions covering regulatory registration, product inspection, innovative products, clinical trials, and quality systems. Leaders of the provincial drug administration and review experts patiently addressed each query one by one. In just about three hours, the event effectively clarified numerous questions and concerns, and all attendees expressed that they had greatly benefited.

The meeting concluded at 12:10 p.m., after which, at 1:10 p.m., the delegation comprising leaders and review experts visited several companies within the park, including Huake Run, Chuangdao, Shengjiekang, and Jianshi. During the on-site visit, they inspected each company’s products, equipment, and production processes, and commended Linfeng Medical Industrial Park for its significant achievements and contributions in the medical device sector.

Leaders of the Drug Administration and review experts believe that Linfeng Industrial Park is one of the leading enterprises in the industrialization of medical devices in the Hangzhou Bay New Area and a national-level innovative medical-device team, having made significant contributions to the industrialization and innovation of the medical-device industry across the province and even nationwide.

This event was jointly organized by the Market Supervision Administration and the Economic Development Bureau of the Ningbo Hangzhou Bay New Area, in collaboration with Linfeng Bio. Leaders in attendance included Director Xie Jianming and Director Hu Xiaoqing from the Economic Development Bureau, as well as Directors Zhu Jian and Chen Zongjun from the Market Supervision Administration.