The purpose of this Act is to promote the efficient management of medical devices and further contribute to the improvement of public health by providing for ...

The purpose of this Act is to promote the efficient management of medical devices and further contribute to the improvement of public health by providing for ...

Regulations For more information. Medical Device Act. Registration Date 2016-03-06; Hit 30727. Medical Device Act ... Korea [28159]; Tel : +82-43-719-1564 (for ...

Medical Device Act. (Act No. 14330, December 2, 2016). CHAPTER I GENERAL PROVISIONS. Article 1 (Purpose). The purpose of this Act is to promote efficient ...

ENFORCEMENT RULE OF THE MEDICAL DEVICES ACT_Ordinance of the Prime Minister No.1819_20220721. 의료기기법 시행규칙(2022.7.21.) Note: MFDS offers the English ...

The primary regulations governing medical devices in South Korea include the Medical Devices Act (MDA) and its associated regulations.

In order to register your medical device for sale in South Korea, you must first obtain approval for your product from the Ministry of Food and Drug Safety.

4 авг. 2021 г. · South Korea's medical device market regulator, plans to roll out several amendments to the country's Medical Devices Act over the course of 2022.

12 сент. 2023 г. · The purpose of this Act [Medical Device Act] is to promote the efficient management of medical devices and further contribute to the improvement ...

This amendment aims to prescribe matters delegated by the Act, such as the type, subscription object, and amount of coverage of insurance or mutual aid.