South Korea's medical device industry has maintained a steady development trend, with an average annual growth rate of 103%。However, compared with other developed countries such as the United States, the international competitiveness of South Korea's medical device industry is still at a low level, and more than half of its approved medical devices are imported.
medwheat will give you a macro introduction to the registration requirements of our neighbor South Korea.
1. Definition of medical devices in South Korea
In Korea, medical devices refer to instruments, equipment, appliances, materials, or other articles that are used alone or in combination with the human body or animals, excluding drugs and drug analogues under the Pharmaceutical Affairs Act of the Republic of Korea, and disability assistive devices under Section 65 of the Welfare of Persons with Disabilities. From a definition point of view, it is similar to the FDA's 1938 definition of a device.
IIMedical Device Regulatory Authority of South Korea
Under the Medical Device Act, the Ministry of Food and Drug Safety (MFDS) under the Ministry of Health and Welfare (MHW) is responsible for the regulation of medical devices. MFDS was formerly known as KFDA (Korea Food Drug Administration), but was officially renamed MFDS on March 23, 2013. The headquarters was relocated to O-Song City in 2010, not because of Korean dramas, but because of the current positioning of Gosong City as a high-end medical industry base in South Korea. South Korea MFDS, currently has 6 branches, as shown in Figure 1 below, of which the office that mainly audits imported devices is in the headquarters:
3. Classification of medical devices in South Korea
South Korea's Medical Device Act divides medical devices into 4 categories ( Some people think that this classification method is similar to that of the European Union, but in fact, it is not appropriate to understand it this way, and this classification method and its regulatory model are closer to the Japanese PMDA method. If there is really no way, you can refer to the EU classification. Because South Korea has its own unique classification system, you can confirm the subdivision categories with Oba specifically.
Class: Medical devices with few potential hazards;
Category: Medical devices with low potential hazards;
Category: Medical devices with moderate potential hazards;
Category: High-risk medical devices.
Medical devices are classified according to: degree of danger, contact area and contact time with the human body, safety and effectiveness of the product.