Asian business opportunities for medical device manufacturers have changed markedly over the past few years ago.
Singapore, for instance, announced its very first set of medical device regulations. By October 2010, all medical devices are to be registered and dealers (including importers and manufacturers) are required to be licensed.
The Singapore medical device market is small but wealthy: Valued at US$235 million, it is roughly the same size as Serbia and Lithuania. Per capita , it is in line with those of South Korea and Hong Kong.
While translation isn't usually a factor when selling devices in Singapore, rules for marketing devices have become stricter. A couple of years ago, Singapore's Health Sciences Authority (HSA) toughened its guidelines for advertising and promoting medical devices in Singapore.
The March 2010 issue of RAPS Focus [login required] has an updated overview of promotional rules in Singapore. (We previously covered some of the advertising rules in China.]
Here are some of the key principles cited in the article and based onHSA's 2009 regulatory guidance [PDF link]:
- All claims must be substantiated.
- Avoid comparisons with other products unless differences are scientifically established.
- Advertisements should not exploit the public's superstitious beliefs.
- Language should be simple to understand ... and avoid using medical jargon.
- Advertisements should not contain any offer to refund money to dissatisfied users.
- All advertisements must comply with the Singapore Code of Advertising Practice.
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