Importers of medical devices need to get an approval from the head of MFDS for each and every product. Report on the standard customs clearance schedule needs to be signed on the electronic documents (XML) by head of KMDIA is a must to import medical devices.
Overseas Trade Act Article 12, Combined Problem (Ministry of Trade, Industry & Energy Notification) Article 33 & 35 Medical Devices Law Enforcement Regulations Article 20
foreign-made medical devices including the ones for license․ declaration, testing, clinical trials
- Korea Customs Service website or through an ASP service provider
- XML templates used for report
Requirement Exempt Import Verification is carried out in the event of import of a medical device classified as being one class below a finished product by a medical device manufacturing permit or a medical device to be used on a ship or aircraft
Overseas Trade Act Article 12, 14, Enforcement Ordinance under the Act Article 19, Combined Problem (Ministry of Trade, Industry & Energy Notification) Article 12 & 29
Manufacturers, importers and repairers of medical devices must report to the KMDIA on the previous year’s production, exports, imports and repairs once a year using a template specified by the KMDIA. Failure to report on time results in administrative measures being taken by the Ministry of Food and Drug Safety. Statistics on the Korean medical device industry are calculated based on the production․import․export of medical devices reported over a number of years. Such statistics are used in the governmental, business and academic sectors to plan the advancement of the medical device industry, engage in international trade negotiations (DDA, FTA), and assess the state of the Korean medical device industry
- Medical Devices Law Article 13, 15, 16, 56
- Medical Devices Law Enforcement Regulations Article 15, 20, Medical Devices Act Enforcement Ordinance Article 14
- Overview of Reports in the Last 5 Years
|Classification||Production||Number of export
|Manufacturers||Reporting rate(%)||Importers||Reporting rate(%)|
As the demand for medical devices is increasing greatly due to the public’s increased interest in health, aging of the population and availability of diverse home medical devices, a medical device advertisement review system was created in April 2007 to prevent losses of the consumers and businesses caused by false advertising and to promote correct use of medical devices by providing the consumers with accurate information on medical devices. Ministry of Food and Drug Safety has designated KMDIA as an agency that evaluates issues on medical devices. Therefore, KMDIA had established a committee that reviews commercials on newspaper, broadcasters, the Internet about medical devices before they are exposed to the public.
Medical Devices Act Article 24, 25, 26
Medical Devices Act Enforcement Regulations Article 29, 29-1, 2nd item of asterisks 6, Article 35 Asterisks 7