Keeping Current with China’s Medical Device Translation Requirements

Managing Chinese Medical Translation Regulatory Updates

Keeping Current with China’s Medical Device Translation RequirementsWhether your company is already registered with China’s Food and Drug Administration (CFDA) or not, it’s a good idea to stay current with the latest foreign medical device translation requirements. No one wants to hit a road bump when it comes to having all of the proper documentation translation ready to go when doing business in one of the biggest healthcare arenas on the planet. This is why the need to know exactly what to translate to Mandarin is a must when entering the Chinese medical device marketplace.

Coming Changes for Foreign Medical Device Registrants in China

Medical device regulators in China are planning to roll out a new regulation that would require foreign medical device makers to translate their basic company information into Simplified Chinese (Mandarin). This includes device labeling (company name and contact information) for foreign firms operating in China.

The changes, which would come into effect in January, 2018, mean business names and addresses, which firms would have to translate to Mandarin, would either have to correspond to the actual name of the company (in English, French, German, etc.), or correspond to the name of the device manufacturer’s representative headquarters in China.

Most companies will be required to notify the CFDA by the end of December, 2018 of any changes made to their company’s addresses and official business name(s). For Class II and Class III medical devices built after January 1, 2019, all labeling will have to include the manufacturer’s information in Simplified Chinese.

Why the Chinese Medical Device Market Matters

According to Export.gov, the medical device marketplace in China is “one of the fastest growing market sectors” in the country, which has been “maintaining double-digit growth for over a decade.” And that positive outlook, coupled with the fact that the Chinese medical device market could approach $60 billion in the next few years, means foreign medical device manufacturers of all sizes are focusing on (or should be) Chinese medical translation and Chinese technical translations.

U.S. firms and other foreign device manufactures enjoy a stellar reputation in China’s healthcare sector. The public and private healthcare sectors also have a lot of room for future growth, as China’s overall healthcare expenditures (close to 6% of GDP) fall below many other countries — but China is making up ground fast. This means there will be more medical device competition entering the market, both foreign and domestic, including many new lucrative business opportunities to chase after.

Chinese Medical Translation Strategies for Foreign Companies

Experienced translation agencies that specialize in Chinese medical translation, technical translations related to the medical device industry, software localization, as well as the day-to-day documentation translation needed to handle regulatory issues, can assist a device manufacturer working in China by facilitating a company’s entry into the marketplace, and then helping maintain its presence and good reputation on the ground.

With proposals for various medical device reforms and new regulations constantly being updated or altered, device manufacturers need to work with a translation agency able to expertly juggle the technical, bureaucratic and political aspects of Chinese medical translation as it pertains to China’s medical device industry now, and as it changes and grows in the years to come.


Medical TranslationRead our whitepaper 5 Case Studies in Medical Translations, a 10 minute read that will help you understand some of the challenges involved and how to overcome them! You can also register to attend the 15 minute free healthcare Translation webinar.

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