In Vitro Diagnostic Medical Devices (HS code 3822.00)

Proposed amendments to the "Enforcement Rule on the Act on In Vitro Diagnostic Medical Devices"; (22 page(s), in Korean)

MFDS is proposing to amend the "Enforcement Rule on the Act on In Vitro Diagnostic Medical Devices" as follows:

A. Enable the elimination of the manufacturer's address on the outer packaging of small size In Vitro Diagnostic Medical Devices.

B. Enable the elimination of duplicate information written on both the outer packaging and attached documents of In Vitro Diagnostic Medical Devices. C. Simplified the submission data required for the application of Clinical Performance Study Plan approval of low-risk In Vitro Diagnostic Medical Devices