The medical machinery market is huge and South Korea is the third largest medical equipment market in Asia

Business News Agency, September 2th Although South Korea has become Asia's largest importer of medical devices, it is not easy for foreign manufacturers to enter the Korean market.

In recent years, China’s exports of medical device products to South Korea have increased rapidly. However, according to analysis, Chinese medical devices imported and exported to South Korea mainly focus on low-value-added common consumables.

Since the Korean War was suspended, after only half a century of construction, South Korea, with a population of only 50 million and a land area of ​​only 100,000 square kilometers, has now become the world’s seventh-largest economic entity. Western economists call South Korea an "Asian miracle." According to predictions of relevant international organizations: South Korea's GDP this year will reach 315 billion U.S. dollars, ranking among the top 20 industrial countries in the world. According to a report issued by an international organization, the total pharmaceutical market in South Korea is approximately 10.5 billion U.S. dollars per capita this year, which is 212 U.S. dollars, which puts South Korea among the world's top 10 per capita medical expenses.

Medical machinery market is huge

In terms of the size of the medical device market, South Korea’s medical device market had sales of 2.5 billion U.S. dollars in 2006, although China’s population was only 1/26 of China’s, and China’s medical device market sales in that year were only 5 billion U.S. dollars. Dollars. In other words, South Korea's per capita purchase of medical device products costs more than ten times the cost per capita of medical equipment purchased in mainland China.

International organizations believe that the Korean medical device market ranks third in Asia, behind Japan and China. This is quite good for a medium-sized Asian country with a population of 50 million. The size of the medical device market in Indonesia, with a population size much larger than that of South Korea (230 million people), Pakistan (about 110 million people), Bangladesh (100 million people), and Vietnam (80 million people), is no match for South Korea. Even Southeast Asia’s richest man, Singapore, has a market for medical devices that is less than a quarter of South Korea's (this is related to Singapore’s population of just over 5 million).

According to foreign media reports, although South Korea has already entered the industrial country community and has a strong steel-making industry, shipbuilding industry, automobile industry and other heavy industries, the medical device industry in Korea is relatively underdeveloped. According to Frost & Sullivan, a well-known US consulting company, up to now, about 70% of the products in the Korean medical device market come from imports, and domestically only about 30%. The United States, Germany, and Japan are the three major suppliers of medical device products in Korea.

My consumables rose

In recent years, China’s exports of medical device products to South Korea have rapidly increased, but according to analysis, Chinese medical devices for transmission to Korea are mainly concentrated on low-value-added common consumables, such as disposable latex gloves, disposable syringes, and infusion sets. , cotton hygiene materials or polymer hygiene materials, respirator type, conventional surgical instruments, catheter products, and so on. As for the large-scale electronic diagnostic equipment required for Korean hospitals, it mainly comes from the United States GE, Siemens Germany, and Shimadzu Corporation. This shows that China's competition in the transmission of medical device products in South Korea is still unable to compete with world-class large companies.

As we all know, the living standards of Korean nationals are generally high, so the demand for medical services is also relatively high. According to a report released by the Ministry of Health and Social Welfare of the Republic of Korea, in 2006, South Korea’s per capita medical expenses were US$709, and this year it is expected to reach US$859. This figure is comparable to that of Western developed countries. Higher medical expenses means that Korean patients can accept more comprehensive and detailed inspections and medical services in hospitals.

Higher barriers to entry of physicians

Although South Korea has become Asia’s largest importer of medical devices, it is not easy for foreign manufacturers’ products to enter the Korean market. According to reports from the U.S. Medical Device Association, the Korean government had already substantially revised the relevant contents of the medical device management law as early as 2003. The important points are now selected as follows, for reference by the Chinese companies wishing to export medical device products to South Korea. .

Class I medical devices: The management of such products is relatively easy. Foreign companies can be allowed to list in South Korea as long as they register with the Ministry of Commerce and Industry of Korea, without the approval of relevant Korean agencies.

Class II-IV medical devices: This type of product must pass the full review of the competent medical device department of Korea and pass relevant tests before entering the Korean market. All II-IV medical device products exported to South Korea must have a complete technical file, including the manufacturer's name, address, date of manufacture, materials and specifications used in the product, product use, product drawings, instructions for use (English and Korean), and use Taboo and so on. Once the foreign manufacturer's II-IV medical device product passes the review, the relevant Korean department will immediately inform the foreign exporter by e-mail.

The entry of products into Korean market licenses and product technology files are two essential conditions for the sale of II-IV medical device products in Korea. As for the time and cost of conducting II-IV medical device testing in South Korea, according to the introduction of the U.S. Medical Device Association, the test or testing time for medical device products in Korea generally does not exceed the complexity of product technical performance. 3 months. This is much shorter than the time required to apply for relevant experiments in India, Pakistan or other South Asian/Southeast Asian countries. It can be seen that the efficiency of Korean government agencies is high.

South Korea's testing fees for foreign medical device products range from roughly $3,000 to $10,000 per item (depending on the technical complexity of the product). As for the medical equipments issued to foreign companies, the licensing standard for each medical device is unified to 800 US dollars. In general, South Korea’s approval procedures and costs for imported medical device products are relatively reasonable (compared with South Asian or Southeast Asian countries).