Medical Device Link.

REGULATIONS & STANDARDS

A complicated language

Of the 6500 languages of the world, Chinese is more complex than average. There are several forms, that is, dialects, of Chinese. There are two different ways to write Chinese even though the spoken language may sound the same. Translation can seem like a legal hurdle to doing business; in fact it is a powerful enabler.

Mandarin is regarded as “standard” Chinese. It is based on the pronunciation of Beijing, is spoken by approximately 900 million people and is the world’s most widely spoken language (followed by English, Hindi/Urdu and Spanish). In China, the dialects of Min, Hakka and Yue (Cantonese) are also spoken, and each of these by approximately as many people as those that speak, for example, French. Thus, Chinese is not straightforward, which is no surprise for a country with an estimated 1.2 billion inhabitants.

Writing Chinese

The writing system is logographic, which means that each character refers to a specific word or concept. In an attempt to promote literacy, former leader Mao modernised the written script as part of the Cultural Revolution and this resulted in two scripts for Mandarin: Simplified Chinese used in mainland China and the unchanged Traditional Chinese used in Taiwan. To further confuse Western companies, in Hong Kong, which has been part of China since 1997, the spoken language is Cantonese and the script is Traditional Chinese, but Simplified Chinese is increasing in use; and in Singapore the script is Simplified Chinese, but the spoken language is Mandarin.

The Traditional Chinese script consists of more than 40000 characters. Mao’s simplification reduced the number, but readers of Simplified Chinese still have to understand 2000 to 3000 characters to be regarded “literate.” The average Chinese dictionary lists approximately 8000 characters. Traditional and Simplified scripts are understood in mainland China and in Taiwan, but using the wrong one or mixing the two can be regarded as culturally offensive.

Language requirements

The State Food and Drug Administration (SFDA), based in Beijing, is the regulatory authority responsible for marketing authorisations for drugs and medical devices. The SFDA website (www.sfda.gov.cn) provides information on registration. Since 1997, and more seriously since 2000, the Chinese authorities have been regulating the medical device sector and in July 2004, specific regulations were issued regarding inserts, labelling and packaging. Much like the European Medical Device Directive, these regulations contain detailed requirements for the information companies must include on a product insert, label and packaging. All medical devices exported to China must carry this information in Chinese. The inserts are reviewed and approved by the SFDA as part of the registration procedure. After approval, the content of the insert cannot be changed unless the insert is resubmitted to the SFDA for a new approval. The regulation lists a number of forbidden expressions concerning efficacy. Claims such as “best effect of treatment,” “full recovery guarantee,” or “immediate effect” are not permitted. Also forbidden are promises such as “money back if not effective,” “most advanced” and “the best.” In addition, the specifications, labels and instructions for use (IFU) of medical devices cannot state any cure or efficacy rates or comparisons with other products.

Between May and September 2005, the SFDA performed a special inspection of instructions, labels and packaging of different kinds of medical devices. The purpose was to discover and rectify major problems concerning medical device instructions, labels and packaging, to standardise their use, and to ensure the safe and effective use of medical devices by the public. The results will be published on the SFDA’s website.

In search of quality translations

High-quality translation is a major issue if the SFDA and end-users are to be satisfied. Quality can make the difference during selection for a shortlist of preferred products. Finding experienced resources is a challenge and the many technical aspects can be daunting.

Systems. A Chinese IFU that looks great on the translator’s screen in Beijing may look extremely different elsewhere unless a Chinese operating system and all the required Chinese fonts are installed. It is safest to use EPS or PDF files for the translated version and print from those. Alternatively, the IFUs can be printed in China (but then they must be transported abroad, because the translated IFU has to be packaged with the device when the device is imported). Whichever way is chosen, it is essential to carefully check all printed materials. The industry has not yet been able to guarantee that, for example, all East European characters display correctly when printed elsewhere, thus it must not be assumed that printing a Chinese file in the United States (US) or in Europe will be easy.

People. There is enough translation capacity in China, but the problem is finding quality translators who have experience with translating IFUs for medical devices. There are 20 universities, including the top five, in Beijing, and good resources can be expected to be found there. It is probably best to outsource this type of work to a translation company in Beijing or in one of the other big cities, or to a company in the manufacturer’s own country with a subsidiary or similar arrangement in China. The translated output, in the final layout, should be carefully reviewed, preferably by a person who understands the device and who is a native speaker of the form of Chinese required, also, one who is an experienced user of the required Chinese script, and in whom the manufacturer has confidence. Any review changes should be discussed with the translator or editor.

User testing. When all parties agree on the translation it is wise to perform a user test. During this test, one or more potential users of the device will follow the instructions step-by-step under the supervision of a product expert and the translator or editor. If it is observed that the users are not using the device in the correct way they should consider rephrasing the text and then invite a new panel of users. In this way, the chances are minimised that the SFDA will reject the translation, which would of course lose important time-to-market. Obviously, user testing is not always possible; for example, one cannot insert a cardiovascular stent just to check the quality of a translation.

Buying the service

The translation sector in China is booming. More and more local translation companies have been set up over the past few years and US and European medical device manufacturers who feel insecure dealing directly with a company in China can work with Western translation companies with a local presence. Buyers of translation services who do not work through regulatory consultants have the choice of using several large and mid-sized international translation companies, which claim to cover any field, or specialised medical translations vendors, who provide services in the medical field exclusively.

The June issue of the journal MultiLingual Computing and Technology (www.multilingual.com) carried several articles on translation aspects of Chinese, and the biannual Localization World translation conference, which typically takes place in the US and Europe, will be held in Shanghai in 2007 (www.localizationworld.com).

Simon Andriesen is Managing Director of MediLingua Medical Translations, Rijnsburgerweg 10, 2333 AA Leiden, The Netherlands, tel. +31 71 568 0862, e-mail: simon.andriesen@medilingua.com, www.medilingua.com.