(1) Reasons for Proposal

In accordance with the amendment to the Medical Devices Act (Act No. 15945, promulgated on Dec. 11, 2018, to enter into force on Jun. 12, 2019), this proposal aims to prescribe matters delegated to it under the Act such as entrustment of the supply of rare and/or urgently needed medical devices, procedures for their supply, the standards, subjects and procedures for reporting of foreign matters in medical devices, investigation into the cause of foreign matter inclusions, and other necessary measures, etc., while amending and/or supplementing certain shortcomings that have surfaced during operation of the current system such as submission of data on clinical testing institutions’ clinical trial procedures and results, etc.

(2) Major Provisions

A. Changes in Matters to be Stated Regarding Quality Manager Information in Business Permission Register (Article 3)

1) The application for permission to engage in medical device manufacturing (import) business requires the applicant to state the resident registration number of the quality manager, but after permission is granted, the permission register of the Ministry of Food and Drug Safety only records his/her date of birth, such that there is a legislative shortcoming where there are different administrative procedures regarding the same matter, etc., and there are actually difficulties in carrying out work such as delays in carrying out administrative measures due to insufficient personal information when imposing administrative fines as a result of the quality manager’s violation of training duties.

2) This proposal aims to require the resident registration number of the quality manager to be stated in the medical devices permission register, such that administrative procedures regarding the same matter are conducted consistently and difficulties in imposing administrative measures for violation of training duties by a quality manager are resolved, with the result that efficiency in administrative work is enhanced.

B. Expansion of the Scope of Institutions Entrusted with Testing for Quality Management (Article 8, Article 31, attached Table 2)

1) Currently when granting permission regarding medical devices, testing data regarding the subject product in the form of testing reports issued by a specialized organization such as a college or a research institute in Korea or overseas, other than a testing institute designated by the Minister of Food and Drug Safety, are also recognized, but testing for quality management after permission regarding medical devices has been granted may only be entrusted to a testing institute designated by the Minister of Food and Drug Safety and/or manufacturer who has received approval of compliance with GMP, such that there is a need to make reasonable changes to the regulations such that the scope of entrustment is the same, etc.

2) This proposal aims to make reasonable changes to the system by enabling manufacturers and/or importers of medical devices to conduct testing for quality management in a specialized organization recognized by the Minister of Food and Drug Safety such as a college or a research institute.

C. Submission of Data on Testing Situation, etc., of Clinical Testing Institutions (Article 24 and attached Form in subparagraph 25-2)

1) A person who has received approval of a clinical testing plan for a medical device is required to make a report on the clinical testing situation including evaluation data, etc., on the medical device’s safety every year by the end of February, but there are no prescribed procedures for checking the clinical testing situation, etc., of a clinical testing institution that conducts clinical tests firsthand, such that there are difficulties in actual management of clinical tests such as the fact that one can only rely on data submitted by a person who has received approval of a clinical testing plan.

2) This proposal aims to require that a clinical testing institution, in the same manner as in a drug clinical test, submit data every year on the clinical testing situation, etc., of clinical tests conducted by the subject institution, thereby contributing to appropriate management and safety of clinical tests.

D. Clarification of Import Procedures for Medical Devices Whose Manufacture Has Been Entrusted to an Overseas Factory (Article 27 (1) 10-2)

1) When an importer imports medical devices according to the Foreign Trade Act and the Integrated Public Announcement, when a manufacturer entrusts manufacture of medical devices to an overseas factory and then imports them, and when a person desires to import parts that constitute parts of medical devices that have received permission/certification or have been reported and have medical device functions, he/she imports them through procedures consisting of standard customs clearance forecast report, etc., but the law on medical devices prescribe compliance matters for importers of imported medical devices only, such that there is a need to clearly prescribe such matters in the case of manufacturers as well.

2) This proposal aims to clearly prescribe that when a manufacturer imports medical devices whose manufacture has been entrusted to an overseas factory or imports parts, he/she shall follow the export/import guidelines according to the Foreign Trade Act, thereby ensuring the predictability of the law.

E. Entrustment of Supply of Rare/Urgent Introduction Needed Medical Devices and Provision of Procedures (Article 34-2, Article 34-3)

1) In accordance with the provision of a legal basis for the supply of rare/urgently needed medical devices as a result of the amendment (Dec. 11, 2018) to the Medical Devices Act, there is a need to prescribe details of matters that have been delegated to subordinate laws such as entrustment of supply and the procedure and method, etc., of supply.

2) The Minister of Food and Drug Safety may entrust work regarding the supply, etc., of rare/urgently needed medical devices to the National Institute of Medical Device Safety Information or medical device-related institutions/associations and allow relevant supply institutions to perform demand survey and information provision work among others.

3) A person wishing to be supplied with a rare/urgently needed medical device shall submit an application to the supply institution; the supply institution shall establish a supply plan regarding the supply quantity and supply method, etc., when it deems supply to be necessary, notify the Minister of Food and Drug Safety and the applicant, and supply the medical device without delay.

F. Procedure and Method, etc., of Reporting of Foreign Matters in Medical Devices (Article 54-2, newly inserted)

1) The amendment (Dec. 11, 2018) to the Medical Devices Act provides a legal basis for reporting when a matter (foreign matter) that is not a source material normally used in the interior of a medical device or its container/packaging, and that poses a hazard upon use or renders the device inappropriate for use, is discovered.

2) Therefore, this proposal aims to provide standards such as a list of foreign matters that, when discovered by a medical device handler, must be reported to the Ministry of Food and Drug Safety, as well as the reporting deadline, reporting method, measures to be taken, etc., thereby minimizing hazards to public health caused by foreign matters.

G. Introduction of On-Site Due Diligence System for Overseas Factories of Medical Devices (Article 56-2, Article 56-3, Article 56-4, newly inserted)

1) In accordance with the amendment (Dec. 11, 2018) to the Medical Devices Act which provides a legal basis for on-site due diligence of an overseas factory of an imported medical device, this proposal aims to provide standards such as a list of preparatory matters in advance of on-site due diligence of an overseas factory, the scope of due diligence, measures to be taken regarding a medical device that poses a hazard to use, procedures for removal of such measures, etc.

2) This proposal aims to create a safe distribution environment for medical devices and enhance their safety through direct investigation of overseas factories and implementation of fundamental measures.

H. Subdivision of Administrative Measures Regarding Failure to Receive Re-examination (attached Table 8 II (5))

1) When a medical device subject to re-examination has not received re-examination, measures such as suspension of business, etc., are imposed, but cases where a medical device has not received re-examination due to failure to submit all re-examination data is subject to the same measures as cases where a medical device has not received re-examination due to failure to submit certain parts of re-examination data, etc., such that there are legislative shortcomings where there is difficulty in imposing reasonable measures and a lack of legal basis for imposing measures against those medical devices that received re-examination through wrongful means.

2) This proposal aims to clearly subdivide cases where a medical device has not received re-examination into: cases where there was a failure to apply for re-examination or failure to submit all data, cases where there was a failure to submit certain parts of data, and cases where re-examination was received through false or wrongful means; and reasonably adjust the extent of measures taken against each case to ensure their effectiveness.

I. Strengthening of Measures Taken Against Failure to Designate Quality Manager, etc. (attached Table 8 II (9) and (12))

1) A manufacturer or importer of a medical device is required to have a quality manager to manage the manufacturing process and quality, etc., and in case of failure to have a quality manager or failure of a quality manager to perform required duties, such manufacturer or importer is subject to measures such as suspension of business, etc. (1st time: warning, 2nd time: for 1 month, 3rd time: for 3 months, 4th time: for 6 months), but because the 1st measure is a warning, such measures are ineffective and the weak sentence compared to similar legislative cases poses fairness concerns.

2) This proposal aims to prescribe that the sentence imposed when a manufacturer and/or importer of a medical device fails to have a quality manager or have a quality manager perform required duties, shall be adjusted to be equivalent to those of similar legislative cases.