• FDA Using Twitter, Telenovelas and Translations to Reach Non-English Speakers

    If you're reading this article, chances are good you take something for granted every day: your ability to read. But even beyond that, the fact that you're reading Regulatory Focus means you're probably fluent in English and well-versed in medical terminology. Many Americans, though, can't read, can't read or speak English, or can't read or speak English well enough to understand the medical terminology that is necessary to interpret the labels on medical products like...
  • China: New Labeling Requirements for Imported Devices

    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 r...