[Checklist for Medical Device Industry] Notice of Amendments to the Personal Information Protection Act and Medical Device Act
Article posted in 2025-02-07 12:03:27 | VEAT
Law firm Veat provided guidance to companies (hereinafter "clients") engaged in the leasing of industrial machinery and equipment, including medical devices, regarding recent amendments to the "Personal Information Protection Act" and the amended "Medical Devices Act" (amended on August 8, 2023, and scheduled to be implemented on February 9, 2025), and matters that clients should particularly note in relation to these changes.
1. Key Considerations Following Amendments to the "Personal Information Protection Act"
The "Personal Information Protection Act," amended on March 14, 2023, has been in effect since September 6, 2023. The main contents of these amendments to the "Personal Information Protection Act" are as follows:
① Strengthened Obligations for Personal Information Protection and Management
The Act stipulates that data subjects can request their personal information processors to transfer their personal information to the data subject or their representative. This strengthens the data subject’s control over their personal information.
This emphasizes that the management and utilization rights of personal data belong to the individual data subject, which is a new paradigm known as "mydata." Mydata is expected to be particularly utilized in the field of individual health information access, storage, transmission, and utilization. Therefore, even when performing duties related to medical devices that process individual health data, it is necessary to be aware of the relevant amended provisions.
② Guaranteed Control over Decisions Made Through AI (Artificial Intelligence) and Automated Systems
The Act has been amended to allow data subjects to reject automated decisions made through AI and similar technologies that significantly affect their rights or obligations, or to request explanations regarding these decisions.
As automated systems utilizing AI are increasingly applied across all aspects of corporate operations, this amendment aims to protect the rights of data subjects. Considering the current situation where AI technology is widely incorporated into medical devices, it is necessary to carefully examine the amendments to the "Personal Information Protection Act."
③ Regulation Harmonization Between Online and Offline Businesses
Previously, the "Personal Information Protection Act" applied separate special provisions to online service providers. This resulted in different regulatory application methods for online and offline businesses, even for the same actions.
This amendment eliminates the differences in regulation between online and offline businesses and establishes that the same regulations can be applied.
④ Relaxed Regulations on Overseas Transfer of Personal Information and Compliance with International Standards
Previously, strict restrictions were placed on the overseas transfer of personal information. However, the scope of permissible overseas transfers has been expanded to align with international standards (Global Standard).
2. Key Considerations Following Amendments to the "Medical Devices Act"
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The "Medical Devices Act" Section 13(Obligations of Manufacturers, etc.) ④ A manufacturer shall not entrust sales promotion activities for medical devices to a person who is not a medical device sales promoter. Section 18(Compliance Requirements of Sellers, etc.) ③ Sellers and lessors shall not entrust sales or lease promotion activities for medical devices to a person who is not a medical device sales promoter. |
According to the amended "Medical Devices Act," which is scheduled to take effect on February 9, 2025, ① manufacturers must not entrust sales promotion activities for medical devices to a person who is not a medical device sales promoter, and ② sellers and lessors must not entrust sales promotion activities or lease promotion activities for medical devices to a person who is not a medical device sales promoter.
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The "Medical Devices Act" Section 13-2(Submission of Expenditure Report on Details of Economic Benefits, etc. Provided) ② When a manufacturer, etc. entrusts a medical device sales promoter with sales or lease promotion activities for medical devices, they must prepare a contract according to the provisions of the Enforcement Decree and retain a copy of the contract and related supporting documents for 5 years each. Section 18(Compliance Requirements of Sellers, etc.) ④ The provisions of Section 13-2 shall apply mutatis mutandis to sellers and lessors in accordance with Section 2. In this case, "manufacturer" means "seller or lessor," and "medical device sales promoter entrusted by a manufacturer with sales promotion activities for medical devices" means "medical device sales promoter entrusted by a seller or lessor with sales or lease promotion activities for medical devices." |
Furthermore, according to the amended "Medical Devices Act," manufacturers, sellers, and lessors must prepare a contract when entrusting sales or lease promotion activities to medical device sales promoters and must retain a copy of the contract and related supporting documents for 5 years each.
In this case, Law firm Veat reviewed whether the client belongs to any of the business types mentioned in the amended "Medical Devices Act" scheduled to take effect and provided guidance on the obligations the client must fulfill accordingly.
Partner with Law firm Veat, specializing in IT, healthcare, and medical devices
Law firm Veat is a law firm with specialized legal experts focused on IT, healthcare, and medical device sectors, possessing a deep understanding of the industry’s characteristics and regulatory environment. Therefore, Law firm Veat provides customized legal advice to help companies in these rapidly evolving technology and medical device industries effectively comply with amended legislation and minimize legal risks.
If you experience legal issues in the operation of your business, such as the "Personal Information Protection Act" and the "Medical Devices Act," please contact Law firm Veat.
Law firm Veat will provide you with tailored legal advice optimized for your specific circumstances.
An example of this case can also be found on the Law firm Veat blog:
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