Before medical devices can be manufactured or sold in South Korea, it must first obtain the approval of the Korea Food & Drug Administration (KFDA). Through a system of testing, the KFDA would reject or approve the manufacture or sale of a product. However, there are several criteria under which a medical device can bypass local testing. In some cases, if a product has undergone testing in the US or elsewhere, results from these tests can help hasten the process of bringing the product to market.
Medical device products coming into Korea must undergo a “Type Test” performed by a KFDA-authorized lab during the pre-market approval process. Once the product has been approved, the Korean importer must also perform “In-house Quality Assurance (QA) Tests” on all shipments of the product before they can be offered for sale in the domestic market. However, some imported medical devices can be exempt from both tests either partially or completely should they meet certain criteria through the submission of foreign test reports or certificates.
Test reports or certificates from foreign countries can be accepted by the KFDA if they meet Korean standards or international standards. Acceptances of these standards are made on a case-by-case basis. Reports that can be submitted to partially exempt local testing are as follows: Biological Safety Test Reports, Electrical Safety Test Reports, Performance Reports, and Foreign Clinical Trials.
In order to be exempted from the “In-house QA Test,” the KFDA must be informed of the manufacturer’s quality assurance. For the US, a Certificate to Foreign Government can be obtained from the FDA to indicate the manufacturer’s compliance with the US Quality System Regulations. With this certification, imports are only subject to visual inspections or checks for proper Korean labels.