By Stewart Eisenhart, Emergo Group
The State Food and Drug Administration (SFDA), China’s medical device market regulator, will begin requiring all outside labeling and packaging of devices to be provided in Chinese starting in April 2013.
According to the SFDA (translation via Google Translate) and the Regulatory Affairs Professional Society (RAPS), a recent SFDA notice sent to the agency’s provincial and municipal branches in China mandates that all outside labeling and packaging of medical devices include a version in Chinese. Failure to provide labeling and packaging text in Chinese will prevent manufacturers and sponsors from marketing their devices in China, according to the translated SFDA notice.
In addition, the notice states that medical device companies based overseas should establish quality management systems to ensure compliance with regulatory requirements in China. (Proof of quality system certification is already a requirement for foreign manufacturers seeking medical device registration in China.)
Foreign manufacturers active or interested in the Chinese medical device market have a few months to get their translation capabilities up to speed, if they haven’t yet done so.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
