(1) Reasons for Proposal

This Partial Amendment aims to allow the conversion of medical devices for purposes such as study/samples for display and improve and supplement shortcomings observed in the operation of the current system, including making it mandatory to submit the use history of medical devices subject to tracking and control.

(2) Major Provisions

A. Transfer reporting tasks regarding the medical device repair business to regional places (Article 35)

1) “The Act on the Partial Amendment of 46 Acts Including the Price Stabilization Act to Transfer Central Administrative Authorities and Office Tasks to Regional Places” (amended on February 18, 2020; to be enforced on January 1, 2021) was amended.

2) This Partial Amendment is intended to reflect the above Act, which is amended to transfer authorities under Article 16 (Notification on Repair Business) of the Medical Devices Act from the Minister of Food and Drug Safety to the head of the Si/Gun/Gu.

B. Clarify information subject to English labeling such as containers (Article 44)

1) While a foreign manufacturing site or address is used to obtain authorization/certification for a medical device from abroad, such information on containers is required to be labeled only in Korean, which calls for an improvement.

2) In this regard, this Partial Amendment allows for labeling a foreign manufacturing site or address in a foreign language if the language is used to obtain authorization.

C. Allow the conversion of medical devices for display (Article 46)

1) Persons who display medical devices must obtain approval from the head of the Regional Office of Food and Drug Safety, and the approved medical device cannot be displayed or used differently from its approved purposes. It is required to return and re-import the medical device to use it for other purposes such as study or a sample.

2) Hence, this Partial Amendment is intended to allow the use of medical devices for study or as a sample to the extent they can be managed after being used for display purposes.

D. Make it mandatory to submit the use history of medical devices subject to tracking and control (Article 50 paragraph 2)

1) Side effects during the use of medical devices subject to tracking and control may be fatal to the human body; therefore, it is required for the user (health professional in a medical institution, etc.) to record and store a patient’s name, address, and use date, and submit the information within 10 days if requested by the Minister of Food and Drug Safety. However, it is difficult to track and control such information if a medical institution goes out of business, which makes it hard to take swift action.

2) In this regard, this Partial Amendment requires medical institutions using medical devices subject to tracking and control as designated by the Minister of Food and Drug Safety to submit the use history of the medical devices periodically (once every six months) to act quickly in the event of harm and protect people’s health and safety.

E. Reasonably improve administrative dispositions for clinical study sites (attached Table 9)

1) If a clinical study site designated by the Minister of Food and Drug Safety to conduct a clinical study for medical devices fails to comply with applicable laws, including clinical study documentation and storage, an order can be issued to suspend its business. However, it is needed to use different levels of administrative disposition reasonably if the impact on the safety of clinical study subjects is minor, considering the nature of a clinical study that is conducted on humans.

2) This Partial Amendment allows administrative dispositions to be reasonably eased if the harm caused by the clinical study site violating the applicable laws is substantially minor for clinical study subjects.