(1) Reasons for Proposal
The Amendment eases application requirements for integrated management of medical device permissions, new health technology assessments, etc.; increases eligibility criteria for quality managers; and relaxes regulations by improving retrospective clinical test procedures, etc.
It also clarifies standards for handling illegal oral advertising, etc., and otherwise aims to address and improve upon a number of weaknesses that have emerged from the operation of the current system.

(2) Major Provisions
A. Newly insert a “changeover to integrated management of medical device permissions, new health technology assessments, etc.” (Article 5)
1) The current provisions stipulate that all required documents concerning permissions, medical cost eligibility checks, and new health technology assessments shall be submitted at the same time when applying for integrated management of medical devices. However, applicants face difficulties in preparing the documents at the same time as applying for integrated management.
2) The Amendment aims to reduce the inconvenience for applicants by newly inserting a “changeover to integrated management” that allows a changeover to integrated management by submitting additional documents during the permission process, in addition to the existing method of applying for integrated management after preparing all required documents.
B. Add “eligibility criteria for medical device quality managers” (Article 11)
1) Medical device manufacturers are required to employ a quality manager who shall conduct affairs concerning the direction and supervision of employees engaged in manufacturing of medical devices, manufacturing management, quality control, safety control, etc., but the medical device industry faces difficulties in finding suitable workers.
2) As the “class 2 medical device regulatory affairs (RA)” qualification has become a national certification (October 22, 2018), the Amendment adds the qualification to the eligibility criteria, thereby enhancing the utilization of national certifications and facilitating the supply of labor in the medical device manufacturing industry.
C. Simplify retrospective clinical test procedures (Article 20, Article 24)
1) Clinical tests that produce results using medical data, etc., without directly contacting people, and therefore pose no risk to participants, are required to obtain a clinical test plan approval from the Minister of Food and Drug Safety in the same manner as clinical tests that are conducted directly on people.
2) The Amendment relaxes regulations by prescribing that clinical tests that are conducted using medical records and other data without directly contacting people may be conducted after being approved by the institutional review board.
3) For clinical tests that use medical records and other data, the Amendment also clarifies provisions concerning assurance of anonymity of personal information and exemption from informed consent.
D. Improve the permanent closure notification system (Article 28, Article 35, Article 37, and attached Form 32)
1) The Amendment improves applicant convenience by prescribing an integrated permanent closure notification procedure that notifies the competent tax office when a permanent closure notification is filed for a medical device manufacturing business, etc.
2) The Amendment also improves provisions by prescribing that, in the event that a permit has been misplaced, a permanent closure notification may be filed by stating the reason for misplacement, instead of requiring permits, etc., to be attached to permanent closure notifications.
E. Reduce the processing time for repair business amendment notification (Article 35 and attached Form 35)
1) Although the processing time for repair business notifications has been reduced from 20 days to 10 days (May 1, 2017), the processing time for amendment notifications remains unchanged at 15 days, which is inefficient in terms of operation.
2) The Amendment reduces the processing time for amendment notifications from the current 15 days to 10 days, thereby aiming to enhance applicant convenience and operational efficiency.
F. Prescribe compulsory reporting of discontinuation of supply by medical device manufacturers and importers (Article 27 and Article 33, attached Table 8)
1) A sudden interruption in the supply of medical devices that require a stable supply due to health and medical reasons may cause problems such as failure to receive timely treatment due to the unavailability of alternative medical devices.
2) The Amendment prescribes that suppliers of essentially required medical devices shall, in the event that the supply of an applicable product is discontinued, report the reasons therefor to the Minister of Food and Drug Safety at least 180 days before the discontinuation, thereby allowing early identification of information on the discontinuation of supply and a timely response before problems arise.
3) The Amendment ensures effectiveness by prescribing an exception where, in the event of unavoidable circumstances such as force majeure or an unforeseen interruption in the supply of raw materials, the report may be filed within 10 days of the discontinuation, and by prescribing standards for administrative dispositions.
G. Amend citations in accordance with amendments to other laws (Article 21)
In accordance with legal grounds for “training hospitals, training dental hospitals, and training oriental medical hospitals” cited when designating clinical testing institutions for medical devices, the Amendment updates provision with the corresponding citations.
 H. Add a submission method for final recall reports (Article 54)
Although the current provisions allow recall protocols to be submitted using a computer program, this does not apply to final recall reports and the Amendment addresses this issue.
 I. Newly insert fee refund regulations (Article 65)
The Amendment newly inserts regulations allowing fees to be refunded in the event that an application is voluntarily withdrawn, etc., thereby aiming to reduce the financial burden on applicants and improve administrative efficiency.
J. Clarify standards for handling illegal oral advertising, etc. (attached Table 8 26)
1) The Rule was amended (December 31, 2018) to include purchase recommendations, product descriptions, and other oral advertising in the scope of medical device advertisements, but this was not reflected in the penal provisions and as a result, there are no regulations to punish illegal oral advertising.
2) The Amendment prescribes standards for handling illegal advertising by oral, demonstrative, or other means, thereby aiming to prevent harm through the punishment and control of false and exaggerated advertising of medical devices by free trial rooms.