South Korea - Proposed Amendments to the "Enforcement Rule on the Act on In Vitro Diagnostic Medical Devices"

​South Korea Ministry of Food and Drug Safety 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.