China Overhauls Medical Device Rules To Boost Scrutiny of High-Risk Products

An overhaul of China’s medical device regulations that goes into effect June 1 will bring significant changes to the industry, including equipment reclassification and increased penalties, practitioners say.

Published March 31 by China’s State Council, the amended Regulations on the Supervision and Administration of Medical Devices revises the “cornerstone of China’s medical device regulatory system,” wrote Chen Yang, Lei Li, and Ling Su in an April 7 alert from Sidley Austin LLP. “The amended Regulation contains important revisions that will significantly impact the medical devices industry in China,” they wrote.

The Regulations were first published in 2000 and revised “in ...