1. Purpose of the Establishment
The Digital Healthcare Products Act has been enacted (Law No. 20139, promulgated on January 23, 2024, and to be implemented on January 24, 2025 / January 24, 2026). This draft aims to establish the procedures and standards for performance certification of digital healthcare and health support devices, the formulation and implementation of distribution management plans, as well as detailed provisions regarding the recall, exchange, disposal, suspension of sale, and public announcement of such devices, all in accordance with the provisions delegated by the law and the necessary measures for its implementation.
2. Key Points
a. Reporting and Changes Regarding Digital Healthcare and Health Support Devices (Article 47 of the draft)
This section clarifies the reporting requirements for digital healthcare and health support devices and establishes detailed regulations allowing for changes to the reported items when necessary.
b. Procedures and Standards for Performance Certification of Digital Healthcare and Health Support Devices (Article 47-2 of the draft)
This section provides detailed regulations on the application for performance certification of digital healthcare and health support devices, the performance tests to be conducted after receiving the certification application, and the issuance of performance certificates.
c. Designation Criteria and Procedures for Performance Testing Agencies (Article 47-3 of the draft)
This section outlines the criteria for designating performance testing agencies for digital healthcare and health support devices, as well as detailed regulations concerning the designation procedures and methods.
d. Formulation and Implementation of Distribution Management Plans for Digital Healthcare and Health Support Devices (Article 47-4 of the draft)
This section provides the necessary content to be included in the distribution management plan, which is developed to ensure the safety, quality, and performance of digital healthcare and health support devices in circulation.
e. Orders and Public Announcements Regarding Recall, Exchange, Disposal, or Suspension of Sale of Digital Healthcare and Health Support Devices (Article 47-5 of the draft)
This section establishes detailed regulations regarding the methods for recalling, exchanging, disposing, or suspending the sale of digital healthcare and health support devices, including the actions to be taken by the operators and the disclosure of related information.
