| |
Mandatory Test & Certification |
Intertek Global Support |
| Product Safety |
Yes |
Yes |
| EMC |
Yes |
Yes |
| Factory Inspection |
Yes |
Yes |
| Telecom & Radio |
Yes, MIC approvals are required for telecom equipment, and some IT equipment. Test reports from laboratories with established agreements (i.e., ETL SEMKO's agreement with KETI) will be accepted. Most EMC and telecom testing must be conducted in Korea. |
Yes |
| Medical |
Yes, medical devices sold in Korea must obtain pre-market approval from the Korea Food & Drug Administration (KFDA). KFDA's Medical Devices & Radiation Health Department undertakes inspection and quality assurance for medical devices, sets radiation standards, manages radiation safety control programs, and conducts research on medical devices, radiation health and related areas. A medical device undergoes one of two different regulatory pathways, depending on its classification, under the Korean regulatory system. KFDA requires pre-market notification for Class I devices and pre-market approval for Class II and Class III devices. Since KFDA issues product licenses only to locally based firms, all foreign suppliers must submit required documentation and receive necessary approvals through their Korean distributors. Medical devices must be approved for sale in their country-of-manufacture before they can be considered by KFDA for registration in Korea. To obtain registration of Class II or Class III devices, KFDA requires a document review of the technical file (registration dossier), and a local type-test performed in Korea on samples imported with KFDA permission. KFDA will examine the submitted documents to verify the product's approval status in the county-of-manufacture to review product certifications, the manufacturer's testing methodology, and to review clinical trial data if required. |
Yes |
| Other |
Yes |
Yes |
사이트맵
