Quality System(KGMP)

Korea Good Manufacturing Practice (GMP) stands for the quality management system that provides the matters to be observed in order to guarantee the quality of medical devices throughout the entire product procedure, including development, purchasing, manufacturing, inspection, packing, installation, storage, shipment, claim and return so that high quality products can be supplied consistently in the Korean market at all times.

We provide detailed service on quality system as follows:

  • Provide explanation on the legal and administrative requirements for medical devices pertaining to K-GMP requirements, as well as guidelines of the MFDS for procedure validation etc., while advising clients on the most effective K-GMP certification strategy;
  • Communication with the relevant government agencies as well as draft and submit K-GMP applications to the MFDS;
  • Provide on-site support when MFDS officials visit the overseas manufacturing sites for K-GMP certification (language support and advice based on Korean laws while responding to MFDS official visit)
  • Provide support in MFDS K-GMP certification review of SaMD & 3D printer based manufacturing procedures.