(1) Reasons for Proposal
In accordance with the amendment of Medical Devices Act (Act No. 14330, promulgated on December 2, 2016) and the revision of the Enforcement Regulations on the same Act (promulgated on December 31, 2018), it is necessary to specify the details of the object, scope, and registration method and procedure of the information to be registered in the integrated medical device information system.

(2) Major Provisions
A. Provide the object, scope, etc., of the information to be registered in the integrated information system (Article 2)
(1) In accordance with the amendment of the Enforcement Regulations on the Medical Devices Act (promulgated on December 31, 2018), it is necessary to specify the matters to be decided by the Notification entrusted by the Act, such as the object, scope, etc., of information for medical device manufacturers and importers to register in the integrated medical device information system.
(2) The amendment specifies the object and scope of information on medical device standard codes, information on products, information on manufacturers and importers, and any other information on medical devices and separates the information that may voluntarily input as needed from the information that manufacturers and importers shall mandatorily input.
(3) The amendment clarifies the object and scope of registration of information to secure a legitimate clarity and, at the same time to facilitate the convenience in civil petitions for information registration.
B. Provide the registration and change methods of medical device information (Article 3 and Article 4)
The amendment requires a medical device manufacturer or importer to register the information of the medical device in the integrated medical device information system through electronic means such as the Internet when he/she supplies medical devices to medical institutions after permission, certification, or reporting, and specifies the scope of information that shall be registered within 10 days if there is a change.