On 18 March 2021, the State Council of China announced certain amendments (the 2021 Amendment) to the Regulation on the Supervision and Administration of Medical Devices (the Medical Device Regulation). The 2021 Amendment...more
This article reveals the mechanics of a growing pilot program for registration of Class II and Class III medical devices to be contract manufactured in China that has gained significant recognition across China over the past...more
The medical device industry in China is highly-regulated and China adopts a “pre-market” recordation or approval system for medical devices. Before any medical device can be manufactured, imported, distributed, or sold in...more
The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will...more