1. Reasons for Amendment

The Amendment increases the target and scope of preliminary examinations of medical devices, clarifies how preliminary examination results are reflected when granting permissions, clarifies the scope of exemption from import requirements for medical devices that are used in clinical trials for drugs, deletes the requirement to specify the place of registration when filing a medical device business permission application or notification, and otherwise addresses and improves upon a number of weaknesses that have emerged from the operation of the current system.

2. Major Provisions

A. Add information to be submitted to verify whether quality managers actually carry out duties (Article 3, Article 26)

1) Under the current provisions, only information verifying the qualifications of the quality manager is submitted when applying for a medical device manufacturing/import business permit and this gives rise to the issue that it is not possible to determine whether the quality manager actually works at the business concerned.

2) Require the submission of information verifying that the quality manager actually works at the business in addition to information to verify the qualifications of the quality manager.

3) Stronger management and supervision of medical device quality managers is expected to ensure the manufacture and importation of safe medical devices.

B. Clarify how preliminary examination results are reflected when granting medical device permissions/certifications or approving clinical trial protocols (Article 9, Article 20)

1) Current provisions prescribe that results from preliminary examinations conducted prior to an application for medical device permission/certification or clinical trial protocol approval shall be considered when granting the permission, certification, or approval, but the details are unclear.

2) Clearly stipulate that notices on preliminary examination results obtained prior to a medical device permission/certification/approval may be submitted when requesting a review of technical documents, etc. or applying for a clinical trial protocol approval.

3) Allowing notices on preliminary examination results to be submitted when applying for a medical device permission/certification/approval is expected to facilitate the timely processing of permissions.

C. Change legal terminology from “피험자 (subject)” to “대상자 (subject)” (Article 20, Article 24, Table 3, Table 9, Form 25, Form 26)

Article 10 of the Medical Devices Act refers to a person who participates in a clinical trial as “임상시험 대상자 (subject of a clinical trial)” while the Rule uses the term “피험자 (subject)”, making it necessary to unify terminology. Accordingly, the Amendment changes the term “피험자 (subject)” to “대상자 (subject)”.

D. Improve the method for obtaining consent from clinical trial subjects, prescribe grounds for exemption from the consent procedure, and modify redundant provisions following enactment of the In Vitro Diagnostic Medical Devices Act (Article 24)

1) There is a need to relax the subject consent procedure as clinical trials that use medical records that are already held by medical institutions do not affect the subjects if personal information in the medical records are pseudonymized.

2) Introduce a system where clinical trials that use pseudonymized medical records may be exempt from the informed consent procedure.

3) Relaxing the consent procedure for clinical trial participation with respect to pseudonymized medical records is expected to promote clinical trials of medical devices using medical records without affecting the subjects.

4) Modify provisions concerning the consent procedure and anonymization in clinical trials that use “remaining specimens” that have been transferred from the Enforcement Rule of the Medical Devices Act to the In Vitro Diagnostic Medical Devices Act following its enactment.

 ※ Article 7 (3) 4 of the In Vitro Diagnostic Medical Devices Act and Article 16 (3) of the Enforcement Rule of the same Act

E. Expand the target and scope of preliminary examinations of medical devices (Article 25, Table 10, Forms 27 and 28)

1) Preliminary examinations currently target matters concerning the technical documents, etc. of newly-developed medical devices and orphan medical devices, making it necessary to expand the scope to allow other medical devices to undergo preliminary examinations.

2) Expand the target of preliminary examinations to include innovative medical devices, medical devices requiring submission of clinical trial data, and medical devices for clinical trials, and clarify the procedures, forms, etc.

3) Expanding the target of preliminary examinations is expected to promote preliminary examinations, expedite the main review, and facilitate timely commercialization.

F. Modify provisions through which medical device permissions are deemed to have been modified (Article 26 (6))

Modify provisions through which permissions are deemed to have been modified, such as by making it easy for businesses to apply the latest specifications to manufacturing and quality control when standard specifications are established or amended

G. Clarify the scope of exemption from import requirements for medical devices used in clinical trials for drugs (Article 32)

1) Medical devices used for research, testing and inspections, clinical trials, etc. that are not intended for domestic distribution are exempt from verification of import requirements and do not require an import business permit, etc. when imported. However, medical devices that are used incidentally in clinical trials for drug products that do not seek approval from the Ministry of Food and Drug Safety are not exempt from import requirements, causing confusion among applicants and incurring time and costs to obtain an import business permission, etc.

2) Add medical devices that are used in clinical trials for drugs that do not seek approval from the Ministry of Food and Drug Safety to the scope of exemption from import requirements, just as medical devices that are used incidentally in clinical trials for drugs requiring approval from the Ministry of Food and Drug Safety are exempt from import requirements.

3) Clarifying the scope of exemption from verification of import requirements is expected to enhance the fairness and predictability of administration.

H. Prescribe grounds to provide contact details for reporting adverse events on medical device package inserts (Article 43)

1) To promote the reporting of adverse events by consumers, it is necessary to prescribe grounds to provide contact details for reporting adverse events on medical device package inserts that can be viewed by consumers.

2) Introduce a system where contact details for reporting medical device adverse events may be provided on medical device package inserts.

3) Stating contact details for reporting adverse events on medical device package inserts is expected to encourage the reporting of adverse events by medical device consumers.

I. Prescribe grounds for making certain low-risk Class I and II medical devices subject to reporting on details of supply (Article 54-2)

1) Reduce the burden of reporting by requiring details of supply to be reported on Class I and II medical devices with low risk to the human body that are secondhand medical devices or materials for medical treatment eligible for health care benefits, and prescribing grounds to omit the report when necessary for public interest purposes, etc.

J. Establish sunset provisions (Article 66)

The decision was made to newly insert sunset provisions to address items lacking sunset provisions in the Enforcement Rule of the Medical Devices Act (outcome of the 2021 review of sunset provisions).

K. Relax standards for administrative dispositions concerning reports on details of supply (Table 8)

Reduce the burden on medical device handlers by relaxing standards for administrative dispositions against violations concerning reports on details of supply.

L. Modify standards for administrative dispositions against institutions conducting non-clinical studies to better reflect reality (Table 9)

Although institutions conducting non-clinical studies on drugs and medical devices are operated under the same regulations, the standards for administrative dispositions against the same violations are more severe for medical devices than drugs. Accordingly, the Amendment relaxes the standards for administrative dispositions against institutions conducting non-clinical studies on medical devices to the same level as that for drugs.

M. Delete the place of registration in the medical device business permission application form and notification form (Forms 1, 33, and 36)

Although applicants specify their resident registration number and place of registration when filing a medical device business permission application or notification, it is possible to check the eligibility of an applicant using only the resident registration number. Accordingly, the Amendment deletes the place of registration from the forms used when applying for a medical device manufacturing (import) business permission or filing a notification on a distribution (leasing) or repair business.