Japan Regulations


The medical device enterprises shall not only expand the Chinese market, but also increase the popularity in the global market to obtain more profits and development opportunities. Therefore, many enterprises try to exploit the European, American, Japanese and South Korean market. As a leading medical device market in Asia, Japan attracts the attention of many enterprises. But in recent two years, Chinese enterprises have been frustrated in exploiting the Japanese market. The export growth declines. Enterprises shall take this issue seriously and timely solve it, to ensure the stability of overseas markets.

The growth of medical device exported to Japan slowed down in 2012. It has been 6 years now. The market must be analyzed to find out the reason. What medical devices does China export to Japan?

Analysis of relevant departments indicates that Japan mainly imports hygienic products from China, such as paper hygienic materials, cleaning paper/cotton, masks and hygienic materials. The paper hygienic materials, mainly including paper diapers and sanitary napkins, are the mostly imported products.

The Japanese hygienic product market had a large share of almost JPY 500 billion early in 2010. The market share keeps increasing in recent years.

Most of hygienic products in Japan are imported, while China is the main exporting country. The Japanese hygienic product market has an increasing dependence on China. To change this situation, Japan intentionally reduces the import of hygienic products from China.

Japan has high requirements for medical devices. However, Chinese enterprises are not up to standards in certain technical controls and product stability. Therefore, Japan adopts centralized purchasing to control the product quality, which is unfavorable to middle and small-sized enterprises in China. Besides, Japan takes advantage of the fierce price war in China to force prices down. In addition, Japan also develops some emerging exporting markets, such as India and Vietnam. Therefore, the growth of medical device import from China slows down.

To change this situation, Chinese medical device enterprises shall solve their own problems, guarantee the product quality, pay special attention to quality control in the product production process, adhere to international standards, improve the product competitiveness in the international market, standardize the industry development and improve the overall strength of the industry, so as to win the competition.