The timeline for medical device MFDS registration in South Korea depends on a number of factors, such as the type of product, the completeness of the application documents, the complexity of the approval process, the review of the quality management system, the need for clinical trials, the workload of regulatory agencies, and regulatory changes. Therefore, it is not possible to give an exact time period for the registration of medical devices in South Korea. Based on years of registration experience, the following estimates are made for the timeline of the MFDS registration process under normal circumstances:
Step 1:In the preparation stage, determine the product classification ( , select Korean KLH for 1 month, you can directly choose Medwheat Korea as the Korean generation.
Step 2:Similar products need to apply for KGMP certificate and accept on-site audit, such products are generally authorized third-party auditors, and obtain KGMP certificate for 3 months. may be audited directly by MFDS.
Step 3:Sample delivery testing can be performed at laboratories in China that meet the requirements of the Korean GLP, which is cheaper than testing in Korea.
Step 4:Handai submits technical documents (technical documents, test reports, KGMP certificates) to MFDS for registration and approval for 1 month.
Step 5:Pay the application fee, issue and rectify the registration documents, and the registration approval will take about 3 months, and the certificate will be held after passing.