In-Vitro Diagnostic Medical Devices; Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, and certified reference materials (excl. compound diagnostic reagents designed to be administered to the patient, blood-grouping reagents, animal blood prepared for therapeutic, prophylactic or diagnostic uses and vaccines, toxins, cultures of micro-organisms and similar products) (HS 3822); Instruments and apparatus for physical or chemical analysis, or for measuring or checking viscosity, porosity, expansion, surface tension or the like, or for measuring or checking quantities of heat, sound or light, n.e.s (HS 902780)

Amendment of "Standards of In-Vitro Diagnostic Medical Devices Good Manufacturing Practices" (18 page(s), in Korean)

Ministry of Food and Drug Safety of Republic of Korea is proposing to amend the "Standards of In-Vitro Diagnostic Medical Devices Good Manufacturing Practices". The main changes proposed are:

For IVD GMP audits that are subject to documentation review only, there are two additional documents that are required to be submitted.