LA Translation Company has trained and provided medical certified interpreters for Korean FDA auditors who come to the U.S. to audit the U.S. company procedures against the Korean Good Manufacturing Practice so that their products can be qualified to be exported into Korea.
One major step for companies registering medium and high risk medical devices in South Korea is compliance with the Korea Good Manufacturing Practice (KGMP) quality system regulations. Similar to ISO 13485 quality system standards, KGMP is required by the Korean Ministry of Food and Drug Safety (MFDS) for all Class II, III, and IV medical devices. The MFDS will verify KGMP compliance via onsite inspections, conducted either by its own staff or with the assistance of Third Party Auditor.
The Korean KGMP implementation and inspection process
KGMP certification must be secured before you can place any Class II, III and IV medical devices on the South Korean market. In order to obtain KGMP certification, you must submit documentation to an MFDS authorized third party auditor, demonstrating that your device complies with design, risk, technical and related KGMP quality system requirements.
Following submission of your KGMP certification application, your manufacturing site will likely undergo inspection by a qualified third party auditor and/or the MFDS depending on your device’s classification:
- Sites for Class II devices are subject to third-party audits only; however the MFDS may request to be present
- Sites for Class III and IV devices are subject to a combined audit by a third-party reviewer and the MFDS
Let LA Translation provide language services for your KGMP compliance project
L.A. Translation and Interpretation, Inc. was established in Los Angeles, CA in 2003 to provide language services to break down language barriers. It has a school approved by the state government to train medical and court interpreters.
- LA Translation has a special program to train certified medical interpreters for KGMP compliance audits.
- Our Seoul office can interact efficiently and effectively with Korean regulators on your behalf.