1. Reason for Revision
In order to activate early utilization of excellent new health technologies and achieve safety and full-cycle management of medical technologies in relation to preceding medical technologies, the revision aims to establish provisions to expand the application eligibility for new health technology subject to suspended assessment and to extend their usage periods, strengthen the management of all preceding medical technologies, and establish grounds for filing objections to the results of assessments of new health technologies and re-assessments of existing medical technologies.
2. Main Contents
A. Regulation on the purpose of enacting the Enforcement Rules (Article 1 of the draft)
The revision adds the entrustment of data collection and investigation work to the matters delegated to the New Health Technology Assessment Committee.
B. Regulation on the application requirements for new health technologies subject to suspended assessment (Article 2 (2) of the draft)
1) The revision restricts re-application for medical technologies that have already undergone a new health technology assessment as new health technologies subject to suspended assessment.
2) The revision expands the scope of medical technologies that can replace clinical literature with clinical trial or clinical performance test data to include all non-invasive medical technologies.
C. Regulation on the matters for examination by the Assessment Committee and Specialized Committee (Article 3 (9) of the draft)
The revision adds ‘urgency’ to the criteria for selecting limited medical technologies, which are matters for examination by the committees.
D. Regulation on the Committee's deliberation methods for the Re-assessment Specialized Committee's examination findings (Article 3 (11) of the draft)
The revision stipulates that the Re-assessment Specialized Committee’s examination findings may be deliberated upon and resolved separately as determined by the Chairperson.
E. Regulation on the management of side effects of new health technologies subject to suspended assessment (Article 3-3 of the draft)
1) The revision stipulates mandatory acquisition of patient consent forms and reporting of the usage status of preceding technologies including new health technologies subject to suspended assessment.
2) The revision establishes a mechanism for withdrawal of new health technology subject to suspended assessment if a high level of risk arises during its use.
F. Regulation on the assessment procedures for new health technologies subject to suspended assessment (Article 3-4 of the draft)
The revision establishes a provision to allow for an extension of the grace period from the existing 2 years to up to 4 years when applying for an extension of the period of use of a new health technology subject to suspended assessment.
G. Regulation on objections to the results of new health technology assessments (Newly established Article 4-2 of the draft)
The revision establishes a provision for requesting re-deliberation in the case of objections to the results of an assessment of a new health technology.
H. Regulation on re-assessment of medical technology (Newly established Article 4-3 of the draft)
The revision establishes a provision to allow for re-examination of the safety, effectiveness, etc. of a medical technology that has undergone a new health technology assessment and changes to the notified matters.
I. Regulation on specialized assessment committees by field (Article 7 of the draft)
The revision establishes a provision to establish specialized re-assessment committees authorized to re-assess medical technologies.
J. Preparation of application form for extension of suspended assessment period (Attached Form 5 of the draft)
The revision establishes a separate form for applications for an extension of suspended assessment period.
