1. Reason for the Enactment

The proposed revision aims to prescribe the detailed types and characteristics of digital technologies applied to digital medical devices in accordance with Articles 2 and 3 of the Digital Medical Products Act and Articles 2 and 3 of the Enforcement Rules of the same Act, the procedures and methods for their classification, their classification and grading, the designation of digital medical device software, and other necessary matters.

2. Main Contents

a. Definition (Draft Article 2)

The revision clearly defines the terms used in the provisions on the classification and grading of digital medical products.

b. Scope of digital medical devices (Draft Article 3)

The revision clearly defines the digital medical devices to be used for the rehabilitation of drug addicts as “digital medical devices” and clearly defines the scope of digital medical device software.

c. Principles for composition of digital medical devices (Draft Article 4)

The revision provides the principles for the composition of digital medical devices, which are composed of diverse elements depending on the type of digital medical device.

d. Application and scope of digital technologies (Draft Article 5)

The revision provides the detailed types and characteristics of digital technologies and the criteria for judging digital medical devices based on the application of digital technologies.

e. Classification criteria for digital medical devices (Draft Article 6)

The revision provides detailed standards so that digital medical devices may be classified based on their names and product codes in consideration of the main purposes of their use, their users, and the types and patterns of digital technologies.

f. Grades of digital medical devices (Draft Article 7)

The revision provides detailed standards for assigning the grades of digital medical devices in consideration of the level of safety management required for each usage according to the functions of digital medical device hardware and software.