China's medical device regulator, the State Food & Drug Administration (SFDA), has a special April's Fools Day planned for medical device manufacturers.
According to a new regulation that will take effect on April 1, 2013, Chinese-language labeling will be required for all foreign medical devices sold in China. Failure to provide labeling and packaging text in Chinese will prevent manufacturers from selling their devices in China, as reported by MassDevice.
MassDevice goes on to say that the new rules also require foreign medical equipment manufacturers to "establish quality management systems to ensure compliance with regulatory requirements in China", although proof of such quality system certification had already been a requirement to register a medical device in China.
For medical translation professionals, this provides further evidence of the importance of China to medical device companies - and medical translators. Go brush up on your Chinese!
[Thanks, Mitch, for the tip!]
You might also be interested in the following related articles:
- Need a challenge? Try navigating China's regulatory system
- Primer: Registering a medical device in China
- Advertising medical devices in China? Pay heed to regulations
- Language fact: Chinese
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