I searched about the Korean Regulatory System
The Ministry of Health and Welfare (MHW) is the primary healthcare agency regulating the importation of medical devices. Under Korea’s Medical Devices Act, the Korea Food and Drug Administration (KFDA), an agency under MHW, independently regulates all medical devices; only when KFDA requests legislation to fulfill its mission is agreement with MHW required. The Medical Devices Act, passed by Korea’s National Assembly in 2003, is now fully in force with the requirement that all medical devices sold in Korea meet Good Manufacturing Practices (KGMP—more on this topic below). Imported medical devices require an original Certificate to Foreign Government (CFG) by the appropriate regulatory body in the product’s country of manufacture before they can be sold in Korea. KFDA requires foreign manufacturers to have local partners or a physical presence (business registration, along with office and warehouse space) in Korea rather than interact with regulators directly. All foreign suppliers must apply for either a manufacturing or importer business license in order to market medical devices. To obtain a business license, an importer must provide a copy of KFDA Form 1, a health certificate of the company representative, a copy of the registered legal entity, and a list of facilities.
An importer can have more than one distributor, but each distributor must either register as an importer, or have an independent consultant hold the product approval so each importer has equal access to it.
All medical devices require pre-market registration from KFDA before they can be manufactured locally or imported into Korea. There are two types of pre-market licenses: pre-market approval for Class II, III, and IV devices and pre-market notification for ClassI devices. Pre-market approval requires a Technical File Review, Safety and Efficacy Review (SER—may be required for devices with new-to-market features), and Type Testing, while pre-market notification requires only a documentary review of product information (no testing is required). A Technical File Review is a “general” technical file review for those products that are basically the same as an already approved product 2(similar to the U.S. 510-K approval), whereas a SER is required for devices unlike those currently available on the market (similar to the U.S. pre-market approval). KFDA now conducts a Technical File Review on all Class II, III, and IV products.