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Beijing Yizhuang IVD Product Registration and Regulation Technical Forum successfully Concluded

2020-11-26 09:29:05 480

In vitro diagnostic products, as the fastest-growing and best-growing sub-industry in the field of medical devices, have attracted much attention from stakeholders. Since the outbreak of the pandemic in 2020, the diagnostic reagents has brought the in vitro diagnostic reagent industry into the public view. In the past two years, new domestic regulations on diagnostic reagents have been issued frequently, and the regulations has become more stringent. In vitro diagnostic reagent companies have encountered many common problems in the product transformation process. In order to help in vitro diagnostic product development companies to better understand regulatory requirements and improve product compliance and conversion efficiency, this forum is specially held.

Analysis of Common Problems in IVD Reagent Review

Rong Sun

Methods of Registration of In Vitro Diagnostic Reagents and Common Problems of Manufacturers

Zhong Yang

Development and Registration of IVD Reagents under the Guidance of Regulations

Congli Cai 

Application of UDI in the field of in vitro diagnostics

Xiaowu Liu

Intellectual property protection strategies in the field of in vitro diagnostics

Hong Wang