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Regulatory Focus™ > News Articles > China: New Labeling Requirements for Imported Devices

China: New Labeling Requirements for Imported Devices

Posted 01 October 2012 | By Ansis Helmanis

Chinese authorities have announced that as of 1 April 2013, all text appearing on the outside labeling and packaging of imported medical devices must be in Chinese, according to a notice issued to provinces, autonomous regions and municipalities by China's State Food and Drug Administration (SFDA) on 24 September.

The Chinese text version can be "attached" to the foreign language, though it is unclear what forms will be permitted. Any devices not in compliance with the regulation by 1 April 2013 will no be allowed to be marketed or used in China, authorities said.

The SFDA notice notes further that, "overseas medical equipment manufacturing enterprises should establish quality management system to ensure that … medical equipment complies with [Chinese] regulations."

Read more:

SFDA - The notice of the State Food and Drug Administration on regulating the labeling and packaging and labeling of medical devices outside

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