(1) Reasons for Proposal
In accordance with the amended Medical Devices Act (Act no. 14330; promulgated on December 2, 2016), this Amendment prescribes detailed matters delegated by Acts and Statutes including the procedures and methods for reporting the details of supply of medical devices. It also prescribes that adverse events that have occurred outside Korea shall be included in the scope of medical device adverse events subject to compulsory reporting, thereby aiming to enhance the predictability and effectiveness of regulations, and to keep the public safe from the harm caused by adverse events arising from the use of medical devices.

(2) Major Provisions

A. Clarify the scope of medical device adverse events (Article 51)

1) Due to the lack of clarity in the scope of adverse events that must be reported by medical device handlers to the Minister of Food and Drug Safety, there has been confusion as to whether an adverse event associated with a medical device, for which a permission or certification has been obtained or a notification has been filed in Korea, is subject to reporting in the event that such event occurs outside Korea.

2) Accordingly, this Amendment aims to enhance the predictability and effectiveness of regulations by clearly stipulating that any medical device adverse event that has occurred or is likely to occur in Korea or abroad shall be reported to the Minister of Food and Drug Safety.

B. Prescribe items, methods, etc., for reporting on the details of the supply of medical devices (Article 54-4 newly inserted)

1) The amended Medical Devices Act (Act no. 14330; promulgated on December 2, 2016) prescribes that where a manufacturer, importer, distributor, or lessor of medical devices has provided any medical device to a medical institution or a distributor or lessor of medical devices, he or she shall report on the details thereof as specified by Ordinance of the Prime Minister.

2) Accordingly, this Amendment aims to lay the groundwork for the enforcement of report system on the details of the supply of medical devices by prescribing the items and methods, etc., necessary therefor and to allow information on the supply of medical devices to be managed electronically, thereby facilitating the follow-up of medical devices and maintenance of order in distribution, etc.

(3) Amendment Details

Partial Amendment to the Enforcement Rule of the Medical Devices Act

Partially amend the Enforcement Rule of the Medical Devices Act as follows.

In Article 51 (1) excluding the subparagraphs, change “to report on matters concerning medical device adverse events” to “to report on medical device adverse events that have occurred or are likely to occur in Korea and abroad (hereinafter “adverse event information”); and “as follows” to “as follows.” In the first sentence of subparagraph 1 of the same paragraph, change “adverse event” to “adverse event information”; and in subparagraph 2 of the same paragraph excluding the items, change “adverse events” to “adverse event information.”
Newly insert Article 54-4 as follows.

Article 54-4 (Reporting on Details of Provision, etc.) ① In accordance with Article 31-2 (1) of the Act, any manufacturer, importer, distributor (hereinafter in this Article includes those exempt from notification of distribution business pursuant to Article 17 (2) of the Act), or lessor of medical devices (hereinafter in this Article “supplier”) who has provided (includes sales and grants) any medical device to a medical institution (includes medical institutions pursuant to the Medical Service Act and public health centers and public health clinics pursuant to the Regional Public Health Act) or a distributor or lessor of medical devices shall report to the Minister of Food and Drug Safety on the status of the details of the provision of medical devices in accordance with the attached Form 48-2 by the last day of the month following the month of provision; provided that where a supplier’s provision falls under any one of the following subparagraphs, the report may exclude the amount and unit cost of provision.

1. Where the provision is of a medical device that is not a material for medical treatment eligible for health care benefits (this means a material for medical treatment specified in accordance with the main sentence of Article 8 (2) of the Rules on the Criteria for National Health Insurance Health Care Benefits);

2. Where a supplier who is a distributor or lessor of medical devices provides a distributor or lessor of medical devices with a medical device that is a material for medical treatment that is eligible for health care benefits (this means a material for medical treatment specified in accordance with the main sentence of Article 8 (2) of the Rules on the Criteria for National Health Insurance Health Care Benefits);

② Notwithstanding the proviso of paragraph 1, the Minister of Food and Drug Safety may, where requested by the Minister of Health and Welfare and in accordance with Article 32 (1) of the Act, request a distributor or lessor of medical devices who is a supplier pursuant to the proviso of paragraph 1 to report on the details of provision including the amount and unit cost of the provision of materials for medical treatment that are eligible for health care benefits. In this case, the distributor or lessor shall report to the Minister of Food and Drug Safety on the details of provision including the amount and unit cost of the provision within 30 days of receiving the request.

③ Suppliers shall use the integrated medical device information system under Article 31-3 (1) of the Act to report on the details of the provision pursuant to paragraph 1 or 2. In this case, the head of the head of the integrated medical device information center pursuant to Article 10-3 of the Decree shall check the appropriateness, etc., of the information on the details of the provision reported by suppliers.
In the main sentence of subparagraph 7 in the attached Table 8 I. General Requirements, change“ one-half (two-thirds for item F) to “one-half (two-thirds for items F and G), and newly insert item G in the same subparagraph as follows.

G. Where a report on the details of the provision under Article 31-2 (1) of the Act has been filed within one month after the deadline
Newly insert subparagraph 29-3 in the attached Table 8 II. Specific Requirements as follows.
29-3. Where, in violation of Article 31-2 (1) of the Act, details on the provision of medical devices have not been reported or have been falsely reported
Article 36 (1) 17-2 of the Act

A. Manufacturer or importer
Suspension of distribution of product concerned for 1 month
Suspension of distribution of product concerned for 3 months
Suspension of distribution of product concerned for 6 months
Revocation of the manufacturing or import permission/certification or prohibition of the manufacture/import of the product concerned

B. Distributor or lessor
Suspension of distribution or leases for 15 days
Suspension of distribution or leases for 1 month
Suspension of distribution or leases for 3 months
Suspension of distribution or leases for 6 months

Newly insert Form 48-2 as per the appendix.

Addenda

Article 1 (Enforcement Date) This Rule shall enter into force as of the day of promulgation; provided that the amended provisions of Article 54-4, subparagraph 7 in the attached Table 8 I. General Requirements, subparagraph 29-3 in the attached Table 8 II. Specific Requirements, and Form 48-2 shall enter into force as of the dates specified in Article 2 of the Addenda.
Article 2 (Enforcement Dates for the Medical Devices Act) The amended provisions of Article 31-2, Article 36 (1) 17-2, and Article 56 (1) 2-2 in the Partial Amendment to the Medical Devices Act (Act no. 14330) under Article 1 of the Addenda to the Partial Amendment to the Medical Devices Act (Act no. 14330) shall enter into force on the following dates.
    A. Class 4 medical devices July 1, 2020
    B. Class 3 medical devices July 1, 2021
    C. Class 2 medical devices July 1, 2022
    D. Class 1 medical devices July 1, 2023
Article 3 (Applicability to Reports on the Details of the Provision of Medical Devices) The amended provisions of Article 54-4 shall apply to medical devices provided by suppliers after the enforcement of this Rule.