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medical device labeling

New Chinese Medical Device Labeling Requirements Set for 2013

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 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.



  • マレーシアMDAは医療機器ラベル規則順守の期限を3年間延長しました。
  • この猶予期間の延長は、マレーシア市場の登録者に遵守のための十分な時間を与えるためのものです。

Malaysian Regulator Push Back Medical Device Labeling Requirements Emergo