In recent years, China’s medical device products for the rapid increase in the number of Korean exports, Chinese exports to the Korean medical equipment used mainly in low value-added on consumables.

Has been since the Korean War armistice, after half a century of construction, only 50 million population, land area of only hundreds of thousands of square kilometers of South Korea, has become the seventh largest economic entity. Western economists said that South Korea as the “Asian miracle.” According to the relevant international organizations Forecast: South Korea’s GDP this year will reach 315 billion U.S. dollars worth, all industrial countries in the world ranked in the top 20. Report published by international organizations: the total size of South Korea’s pharmaceutical market of about 105 billion U.S. dollars, South Korea this year to $ 212 per capita medical expenses, the figure included in the world to South Korea’s top per-capita medical expenses 10.

Yixie huge market

Size of the market for medical devices, although South Korea’s population of only China’s 1 / 26, but in 2006 South Korea’s medical equipment market sales of 25 billion U.S. dollars, while China’s medical device market this year, sales were 50 billion dollars. In other words, Korea’s per capita cost of procurement of medical equipment products per capita in China is equivalent to the cost of procurement of medical equipment more than ten times.

International organizations that the South Korean medical device market is the third largest in Asia, behind Japan and China. This is a population of only 50 million middle-Asian countries has been quite good. Indonesia’s population size is much larger than South Korea (2.3 million), Pakistan (1.1 million), Bangladesh (1 million) and Vietnam (8000 million) each for a medical device market can not and Korea. Even the richest man in Southeast Asia – Singapore, the medical device market in Korea, only less than 1 / 4 (which is only 500 million population in Singapore on).

According to foreign media reports, although the Republic of Korea have entered the industrial countries, social, and has a strong steel industry, shipbuilding, automotive industry and other heavy industries, but South Korea’s medical equipment industry in general is relatively underdeveloped. Such as the American consulting company, according to Frost & Sullivan reported that, until now, South Korean medical device market is about 70% of the products from imports, domestic only 3 percent or so. United States, Germany and Japan, the Republic of Korea’s three major medical device supplier countries.

South Korean national standard of living is relatively high, so the relatively high demand for health care. According to the Korea Ministry of Health and Social Welfare reported disclosure: In 2006, the South Korean national per capita health expenditure was $ 709, is expected to reach $ 859 this year. This figure compared favorably with the Western developed countries. Means higher medical expenses is more acceptable to patients in hospitals ROK comprehensive and detailed equipment inspection and medical services.

Yixie high barriers to entry

Although Korea has become Asia’s largest importer of medical devices, but the products of foreign firms want to enter the Korean market is not easy. Medical equipment, such as chambers of commerce, according to U.S. reports, the South Korean government as early as 2003 already substantially modified the law on medical equipment management-related content, choose the important point is described below, for want of Korean exports of medical products businesses as a reference .

Ⅱ – Ⅳ class medical equipment: such products must pass the Korea Medical Devices comprehensive review of the competent authorities, through the relevant tests in order to enter the Korean market. All exports of South Korea Ⅱ – Ⅳ class medical device products must have a complete technical file, including the manufacturer’s name, address, date of production, product and the materials and specifications, product applications, product design, the use (in English and Korean) and the use of taboo and so on. Once foreign firms Ⅱ – Ⅳ class medical device products through the review, South Korea, the departments concerned will immediately send e-mail messages by way of informed foreign exporters.

Products to enter the Korean market and product technology licenses files are Ⅱ – Ⅳ class medical device products sold in South Korea two essential conditions. As in Korea Ⅱ – Ⅳ class medical device product testing time and costs, according to the U.S. medical device trade associations in recent figure, according to the complexity of the technical performance of products in South Korea as a medical device product testing or detection time usually does not exceed 3 months. Than in India, Pakistan or other South / Southeast Asian countries to do experiments to apply much shorter time, we can see that the South Korean government agencies high efficiency.

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