Given Japan’s conservative regulatory environment, it should come at no surprise that advertising and promotion of medical devices and pharmaceuticals in Japan is highly regulated and very restrictive. Without shonin, or “approval” of a product, advertising the name, manufacturing process, indications, effects, or properties of medical devices or pharmaceuticals is prohibited by law. While products awaiting shonin may be exhibited at trade shows, a sign indicating that the product is unapproved must be prominently displayed, and the exhibitor is restricted from speaking about features, benefits, pricing, distribution, and the like. Additionally, no literature about the product, including leaflets, pamphlets, catalogues, etc. may be distributed.
With respect to Internet advertising of medical devices or pharmaceuticals, at present there are no specific regulations. A number of websites exist today that promote unapproved medical products to the Japanese market. In fact, many of these websites are for the sale of such devices. Such sites utilize a loophole that allows unapproved medical devices to be imported into Japan under a “for personal use” designation.
The Japanese government is still contemplating its official stance with regard to advertising on the Internet. However, government officials have stated that if such a website is physically located in Japan, and if the advertising is blatantly false or misleading, than the government would try to reason with the advertiser, using “administrative guidance” or a “soft” approach. If the company were to resist government pressure or if the company was attempting to sell its unapproved products directly to a Japanese audience, the government might take a more pro-active stance. For websites physically located outside of Japan, the government has admitted that there is little they can do, though if the violation is considered particularly flagrant, indirect pressure through a local Japanese subsidiary or through diplomatic channels could be used.