1. Reason for the Amendment
In the rapidly changing medical science ecosystem, the amendment aims to ensure patients' medical choice rights through the early market entry of newly developed medical devices, strengthen medical device quality and infrastructure by increasing approval and inspection personnel, and promote realistic fees for new medical devices. The amendment also reflects recommendations for improvements based on the evaluation results of the Personal Information Protection Commission concerning personal data infringement factors (Business registration → Business registration certificate). Additionally, to reduce the burden of complaints regarding the repeated submission of qualification documents when the quality manager of a medical device company changes jobs, a regulation has been introduced to exempt the submission of such documents.

2. Key Provisions

a. Revision of the Approval Fee for Newly Developed Medical Devices (Addition of Annex 10, Item 3-2)

• The fee regulations for the approval of new medical devices, including "technical document and clinical trial data review," "technical document review," "clinical trial data review excluding technical document review," and "approval review."

b. Revision of Pre-review Fees for Newly Developed Medical Devices (Addition of Annex 10, Item 19)

• Pre-review fees for "manufacturing/importing technical document review" and "clinical trial data review excluding technical document review" for new medical devices.

c. Introduction of Fee Reduction for Newly Developed Medical Devices (Amendment of Article 65, Section 1, Item 3, and Addition of Notes in Annex 10)

1. A new regulation has been introduced to reduce fees for pre-review and approval of new medical devices to alleviate the economic burden of applicants and support business stability (up to 50% reduction).

2. If the pre-review result is favorable, applicants can pay only the amount after deducting the pre-review fee from the total fee when applying for manufacturing/importing approval (including technical document review, etc.).

d. Exemption from Submission of Qualification Documents for Quality Managers when Re-employed (Amendment of Article 3, Section 1, Item 3-a, and Article 26, Section 1, Item 2-a)

• Establishes a basis for exempting the repeated submission of qualification documents for quality managers when they change jobs to prevent unnecessary administrative burden.

e. Administrative Penalties for False Reporting by Medical Device Manufacturers, Importers, Repairers, Sellers, and Lessors (Amendment of Annex 8, Individual Criteria Items 1-2 through 1-4, Items 13-2, 17-2)

• Reflects administrative penalty criteria for false reporting of business information by medical device manufacturers, importers, repairers, sellers, and lessors, as defined in Article 36, Section 1, of the Medical Devices Act.

f. Administrative Penalty Criteria for Medical Device Sales Representatives (Amendment of Annex 8, Individual Criteria Items 10-2, 17-3 through 17-4, Items 20, 20-2 through 20-4)

1. For those who report medical device sales representatives using false or other fraudulent methods, the report will be canceled.

2. When a sales representative fails to meet reporting standards, administrative penalties will be imposed as follows:

• 1st violation: 1-month suspension of sales/rental promotion.

• 2nd violation: 3-month suspension of business.

• 3rd violation: 6-month suspension of business.

• 4th violation: closure of the business location.

g. Fee Standards for Medical Device Sales Representative (Change) Registration (Addition of Annex 10, Item 20, 20-2)

1. Registration fee: 10,000 KRW, Change of registration fee: 5,000 KRW.