Regulations on Approval, Implementation and Management of Clinical Trial Plans for Digital Medical Devices

1. Reason for the Enactment

These regulations prescribe the matters necessary for the approval of plans, performance, and guidelines for clinical trials and clinical performance tests of digital medical devices as the Digital Medical Products Act has been enacted (Law No. 20139; promulgated on January 23, 2024; effective from January 24, 2025) along with its Enforcement Rules.

2. Main Contents

a. Definition (Draft Article 2)

The Regulations clearly define the terms used in the provisions regarding the approval of plans, performance, and management of clinical trials of digital medical products.

b. The Regulations provide the methods of preparing the documents to be submitted for the approval of plans for clinical trials of digital medical devices, requirements, etc. (Draft Article 3 and Article 6)

The Regulations also stipulate how to prepare the documents to be submitted when applying for the approval of plans for clinical trials of digital medical devices, their requirements, and the scope of exemptions.

c. Preparation of documents to be submitted when applying for the approval of plans for digital medical device clinical trials to be performed by entities other than clinical trial institutes, and their requirements (Draft Article 4).

The Regulations provide the method of preparing the documents to be submitted when applying for approval to have clinical trials of digital medical devices performed by entities other than clinical trial institutes, and their requirements.

d. Subjects eligible to apply for approval to change the plan for digital medical device clinical trials, documents to be submitted, etc. (Draft Article 5)

The Regulations provide detailed provisions on the persons or entities who may apply for approval of changes to the plans for clinical trials of digital medical devices and the documents to be submitted.

e. The Regulations clarify the clinical performance tests subject to approval by the Minister of Food and Drug Safety (Draft Article 7).

The Regulations clearly define the method of collecting specimens that must be approved or revised by the Minister of Food and Drug Safety when applying for approval of a clinical performance test plan.

f. The Regulations provide detailed management standards for conducting clinical trials of digital medical devices (Draft Article 8).

The Regulations also provide the standards for conducting and managing clinical trials, including their basic principles and the duties of test labs, review committees, testers, and sponsors.