China Medical Device Labeling Gets Sticky in 2013

by Translation Guy on October 22, 2012

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.


  1. Bill says:

    So, wait… Medical devices in China weren’t labelled in Chinese, or aren’t labelled in Chinese? This seems a little bit dangerous, considering that not every health care worker is multilingual. I cetainly hope the malpractice laws in China took these things into account, there ust be some brave paitents over there.

  2. Julie Bladon says:

    Given the environmental factors in China as well (having been in Beijing and heard locals call smog and smoke, fog) I can foresee the health of their aging population and even the younger factions debilitating quite badly.

    • Ken says:

      Add a rapidly aging population and you’ve got the perfect medical device storm.

  3. I know China manufacturs everything these days, but given their quality issues, I can’t see the demand for Chinese manufactured medical equipment being a gigantic growth market. Give nice German efficiency when it comes to something that needs to be inserted in my body.

  4. Warren Paul says:

    Nice of you to ask yourself your opinion one this matter, it seems the industry sentiment is tracking in your direction, how fortunate.

    • Ken says:

      I don’t interview myself often, since I’m not always the most reliable source.

  5. clara says:

    Well it’s nice of the Chinese authorities to think of this, given that with billions of Chinese, and probably millions of procedures done, there have been quite a few mishaps due to linguistic issues.

  6. Katie Grant says:

    It amazes me that China is only the second largest market for anything in Asia, just based on sheer size they should dominate market share on everything, but I guess quality of life isn’t what it should be over there.

  7. Ric Thompson says:

    I can’t imagine in a country like China, that takes Chinese cultural promotion so seriously, that medical devices were not mandated to be labelled and packaged in Chinese from day one. It just seems incredibly odd.

  8. Emma Dennis says:

    I thought a quasi-communist nation would have pages upon pages of regulations in regards to this already.

  9. Holly says:

    The question is not how big the market for medical devices is, but how big the market for translation for medical device packaging and labelling is or will grow to be. Those are the important numbers, or at least around here they are.

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