1. Reasons for Amendment

This amendment aims to strengthen the quality management of in vitro diagnostic medical devices by establishing a rapid review system that includes simplifying submitted materials, including integration and abolition of similar documents among application documents, and switching to review by a single quality control review institution.

2. Major Provisions

 A. Change the review body between a regional office of food and drug safety and a quality control review agency (Attached Table 4)

Conduct jointly field investigations for changes in the locations of grade 3/4 and regular inspections However, document reviews shall be independently performed by a quality control review agency, and investigations of Grade 3/4 medical devices for export shall be independently performed by a quality control inspection agency.

B. Streamline document submission requirements (Article 7)

Secure the reliability of GMP conformity certification by submitting practical review materials such as integrating or abolishing similar materials among the submitted materials in the current document review process.

C. Clarify review procedures, such as in vitro diagnostic medical device manufacturing and quality control standards conformity certification (Article 8)

The proposed amendment stipulates that applications for conformity assessment for an in vitro diagnostic medical device manufacturing and quality control standard conformity certification review, the submitted required documents shall be checked within 5 days rather than only accepting them if they are without fault as currently stated.

D. Exempt from the review of changes in locations of in vitro diagnostic software manufacturing factories (Article 4 (1) 3)

1) In vitro diagnostic medical device manufacturing factories shall be equipped with facilities (workroom, depository, laboratory, etc.), but in vitro diagnostic software manufacturing factories shall be excluded from such requirements.

2) Accordingly, in vitro diagnostic software manufacturing factories are excluded from the “change review” that should be received when the location of an in vitro diagnostic medical device manufacturing factory (facility) is changed.

E. Improve the regulation on GMP audit submissions for in vitro diagnostic software manufacturing factories (Article 7)

For in vitro diagnostic software manufacturing factories, improve the regulation so that the relevant facility shall be included in the floor plan only when there is a workroom, laboratory, or depository as a requirement for documents submitted for review application.