Regulations, No.: FDISM/FDIC/TRG/001 Rev_3, governing licensing of public and private manufacturers, distributors, wholesalers and retailers of medical Products; (13 page(s), in English)

Proposed amendments to the "Regulation on Medical Device Group and Class by Group"; (9 page(s), in Korean)

FDA Circular: Guidelines on the Maintenance of Importation and/or Distribution Records, and the Reporting of Product Complaints, Adverse Events, and Field Safety Corrective Actions for Medical Devices; (15 page(s), in English)