1. Reason for the Amendment
To reduce the burden of complaints caused by the repeated submission of qualification documents when the quality manager of an in-vitro diagnostic medical device changes jobs, an exemption from submitting qualification documents is introduced. In addition, for personal blood glucose test strips, which can be affected by temperature and humidity over time after opening due to the nature of in-vitro diagnostic medical devices, the amendment requires that the period of use after opening be indicated on the packaging. Furthermore, the amendment aims to promote the early market entry of newly developed in-vitro diagnostic medical devices to ensure patients' medical choice rights and to enhance the quality and infrastructure of these devices by realistic fee adjustments for the approval of new devices.

2. Key Provisions

a. Improvement of Document Submission for Quality Manager Reemployment (Article 4, Section 1, Subsection 3)

• To alleviate public inconvenience, the amendment provides a basis for replacing the repeated submission of qualification documents with the initial documents submitted during registration when the quality manager changes jobs due to reemployment.

b. Unification of Level 1 Product Notification System and Clarification of Notification Processing Time (Article 5, Section 2, Annex Form 7, Annex Form 18)

• Although Level 1 products have a low risk, they are currently required to go through approval procedures if no existing product is available. The amendment unifies Level 1 products under the ‘notification’ system and clarifies the processing time for notifications, thereby improving administrative transparency.

c. Addition of "Period of Use After Opening" on Packaging (Article 36)

• For multi-use products (such as personal blood glucose test strips), which may experience performance degradation due to the influence of temperature and humidity after opening, the amendment requires that the period of use after opening be indicated on the external packaging.

d. Amendment of the Approval Fee for Newly Developed In-Vitro Diagnostic Medical Devices (Annex Form 3)

• The amendment clarifies the fees for the approval of newly developed in-vitro diagnostic medical devices, including fees for the review of technical documents, clinical performance test data (if technical documents are not included), and the overall approval process.