대한민국 영문법령

MEDICAL DEVICES ACT

조문단위인쇄
Article 46-2 (Special Cases concerning Medical Devices in Cases of Infectious Disease Pandemic, etc.)

(1)

At the request of a relevant central administrative agency (including the Centers for Disease Control and Prevention), the Minister of Food and Drug Safety may engage in the following activities to adequately respond to infectious disease pandemic (including an outbreak of an infectious disease that could turn into a pandemic) under the Infectious Disease Control and Prevention Act or radiological emergencies under Article 2 (1) 7 of the Act on Physical Protection and Radiological Emergency:

1.	Notwithstanding Article 6 (2), an act of having manufacturers who have not been granted manufacturing permission or manufacturing certification or who have not filed a manufacturing notification with respect to medical devices engage in manufacturing;

2.	Notwithstanding Article 15 (2), an act of having importers who have not been granted import permission or import certification or who have not filed an import notification with respect to medical devices engage in importing.

(2)

Notwithstanding Article 26 (1), the Minister of Food and Drug Safety may require medical device handlers to repair, distribute, lease, provide or use medical devices manufactured or imported under paragraph (1) or to store or display any medical device with intent to distribute, lease, provide or use such medical device.

(3)	Reasons for request by a relevant central administrative agency under paragraphs (1) and (2), the scope of medical devices subject to exemption from procedures, permission, etc. and ex post facto handling criteria, such as collection of medical devices, shall be prescribed by Presidential Decree.

[This Article Newly Inserted by Act No. 15486, Mar. 13, 2018]

<<Enforcement Date of Article 46-2 : Sep. 14, 2018>>

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