Written by ForeignExchange Translations on Monday, April 05, 2010
When executives at medical device manufacturers think about the opportunities in Asia, they are bound to get giddy. Just look at some of these facts, reported in Asian Hospital & Healthcare Management:
- Asia has 60% of the world population but only 15% of global healthcare expenditure.
- Healthcare expenditures are growing at an annual rate of 6.2% across Asia.
- Some parts of Asia are experiencing high population growth, while other countries are faced with rapidly ageing populations, as shown here:
With all of these opportunities presenting themselves, it is no wonder that device companies (and drug companies and any other company selling to the healthcare sector) are paying close attention to new and changing regulations that might influence how they can promote their products.
Because where there are opportunities, there are risks. Here is a statement from a typical 10-Q report:
Compliance with the extensive government regulations to which we are subject is expensive and time consuming, and may result in the delay or cancellation of product sales, introductions or modifications.And:
Extensive industry regulation has had, and will continue to have, a significant impact on our business ... [D]omestic and foreign statutes and regulations govern or influence the research, testing, manufacturing, packing, labeling, storing, record keeping, safety, effectiveness, approval, advertising, promotion, sale and distribution of our products.The current issue of RAPS Focus has a good article on the latest Advertising and Promotion Policies in China, Japan and Singapore [login required]. The article presents a good overview of the general rules in these three major markets.
In China, manufacturers must take care that certain claims are not included in advertisements. Here is just a sampling:
- guarantee of effectiveness
- efficacy or recovery rates
- safety of effectiveness comparisons with other devices
- nonscientific description of the device's performance characteristics
On the other hand, certain disclaimers (in Chinese) must be included. As an example, "Contraindications and cautions are specified in the product manual." must be featured in the advertisement, as applicable. For international marketing managers and translation service providers alike, this means that advertisements destined for China can't "just" be translated but must be localized and adapted.
If you are involved in producing Chinese-language advertising materials for medical devices, it pays to understand these guidelines!
ForeignExchange provides specialized medical translation and localization services to medical device companies - in Chinese and 40+ other languages. For your next international marketing campaign, ask for a detailed proposal.