Create New Stream of Revenue from your Medical Device in Japan

Approval for medical devices can take longer in Japan than in other developed markets, but presence in the Japanese market is essential for any company seeking international growth. US companies have a distinct advantage in Japan, since the US medical device industry is considered the most advanced in the world. Capitalizing on this technological lead and selling in Japan, the second largest market in the world for medical devices, can lead to a significant source of revenue.

The Japanese government is doing its part to make the approval process more efficient. In 2005, Japan's Ministry of Health, Labor and Welfare (MHLW) amended the Pharmaceutical Affairs Law (PAL), reorganizing regulatory bodies and streamlining the product review process to lead to faster approval times. The amendment also served to "harmonize? regulations and safety measures with those of other developed markets, making the regulatory landscape more amenable to US companies.

Many US companies have successfully received approval for their products in Japan, on average 2.5 years after receiving approval in the US. The following chart lists products that were approved in Japan just in the past year:

The opportunities in the Japanese market are certainly worth the investment. Estimated at $19 billion in 2004 by the US International Trade Commission (USITC), Japan's medical device market is the second largest in the world. For the same year, the US is reported to have supplied 58 percent of Japan's medical device and equipment imports, showing that US companies already have a significant weight in the market.

Furthermore, because US companies are the frontrunners in many sectors of the medical device industry, products from the US are highly sought after in the Japanese market, even years after their US approval. Products that have been available in the US before their release in Japan also have an opportunity to establish a track record of safe and successful implementation, adding to their marketability in Japan.

In addition, while the US medical device industry has a technological lead in a wide range of advanced products, including cardiovascular devices, pacemakers, defibrillators, catheters, and artificial limbs, Japan on the other hand, according to the USITC, tends to focus on two main areas: imaging devices and general hospital supplies. The disparity in the two industries creates tremendous opportunities for US companies to fill the demand for more advanced devices.

The opportunities in Japan call for market entry from any company seeking global growth. With a technological lead over much of the world, US companies have a significant advantage. Companies that take advantage of their technological lead and opportunities in Japan can seek to generate a significant new source of revenue.