China Medical Device Labeling Gets Sticky in 2013
China’s State Food and Drug Administration (SFDA) will require all outside labeling and packaging of devices to be in Chinese by April 2013.
Failure to provide Chinese labeling and packaging text will result in market banishment.
We asked TranslationGuy, noted industry analyst, if this law was a good idea.
“Hell yes, it’s a good idea. More translation is a good idea. Your average Chinese Joe has a right to know what it says on the label before they stick a medical device inside him. It’s good for business, my business most of all! Plus, good translation saves lives. Who wants to be on the wrong side of that one?”
But not just any translation. SFDA officials require that “overseas medical equipment manufacturing enterprises should establish quality management system to ensure that … medical equipment complies with Chinese regulations.”
So I pulled the adding machine off the top shelf, blew off the dust, and set to figuring if we were going to have to build a new word mill below the translation memory pond to handle all that new Chinese label demand.
China’s medical device market has grown to $8.8 billion, the second largest in Asia after Japan. The number of foreign medical device manufacturers selling, sourcing, or manufacturing in China has grown exponentially. However, there are still quality control problems with recalls and scandals.
The Chinese medical device market still relies on imports, and the unique Chinese combination of fast economic growth and rapidly aging population ensure growing demand. China’s medical device sales are estimated to reach $45 billion in the next decade.
“Besides increased awareness, one of the key factors contributing to the market growth is patient demographics in China. As the disease incidence caused by the aging population continues to rise in the country, there will be strong demand from patients seeking advanced medical procedures and techniques that can provide safe and effective diagnoses or treatment, ultimately driving an upsurge in the use of medical devices,” say experts.
Some useful resources for those interested. Regulations for the Supervision and Adminstration of Medical Devices. That’s the law. Also of possible interest, Brief Introduction of Medical Device Regulations in China by Chang Yongheng, Deputy Counsel in the SFDA’s Department of Medical Devices. From 2007 but a good overview.