CONTENTS
- 1. Violation of the Medical Devices Act | Concept
- - Definition of a Medical Device
- 2. Violation of the Medical Devices Act | Main Conduct and Punishment
- - Approval, Certification, or Notification by False or Improper Means
- - Conduct Related to Labeling and Advertising of Medical Devices
- - Manipulation of Clinical and Non-Clinical Reports and Related Acts
- - Joint Penalty Provisions
- 3. Violation of the Medical Devices Act | Administrative Disposition
- - Revocation of Designation and Business Suspension
- - Penalty Surcharge Disposition
- 4. Violation of the Medical Devices Act | Methods of Response
- - Responding to an Inquiry
- - Filing of an Administrative Appeal
- - Filing of Administrative Litigation
- 5. Violation of the Medical Devices Act | Response Strategy and Legal Support
1. Violation of the Medical Devices Act | Concept
A violation of the Medical Devices Act refers to an act that violates the statutes concerning the manufacture, import, sale, advertising, and similar activities related to medical devices.
The Medical Devices Act is a statute that regulates overall matters such as the manufacture, import, sale, advertising, and quality control of medical devices, and its ultimate purpose is to protect public health and to secure the safety and effectiveness of medical devices.
Definition of a Medical Device
The Medical Devices Act defines medical devices not merely as machines but as a wide range of products, including instruments, machines, apparatus, materials, and software.
• Products intended to diagnose, treat, or correct injury or disability
• Products intended to examine, replace, or modify the structure or function of the human body
• Products intended to control pregnancy
※ However, drugs and quasi-drugs under the Pharmaceutical Affairs Act and certain assistive devices for persons with disabilities (prostheses and orthoses) under the Act on Welfare of Persons with Disabilities are excluded.
2. Violation of the Medical Devices Act | Main Conduct and Punishment
Because a violation of the Medical Devices Act can affect public health and safety, strict compliance with the relevant laws and regulations is of the greatest importance.
Even a small mistake or oversight can lead to a significant legal problem, so all parties involved in the manufacture and distribution of medical devices should pay careful attention to responsible management and accurate compliance with procedures.
The following are the main types of violations of the Medical Devices Act.
Approval, Certification, or Notification by False or Improper Means
Where a person obtains a license or certification, or makes a report, by false or improper means in the procedure for licensing the manufacturing or import business of medical devices, certifying medical devices, or making a related report, this constitutes a violation of the Medical Devices Act.
The same applies where a person repairs, sells, leases, grants, or uses an unlicensed medical device, or manufactures, imports, repairs, stores, or displays one for such purposes.
This is subject to the following punishment.
Medical Devices Act, Article 51 | Imprisonment for up to 5 years or a fine of up to 50 million won |
Conduct Related to Labeling and Advertising of Medical Devices
Marking or writing the following content on the container, outer casing, packaging, or accompanying documents of a medical device is prohibited.
• Performance or efficacy that was not approved or that differs from the reported content
• Methods or periods of use that raise concerns of harm to public health and hygiene
The following advertising acts are also strictly prohibited.
• Advertising that causes misunderstanding of a medical practitioner's endorsement, recommendation, or official certification
• Advertising through articles, photographs, or designs that suggest performance or efficacy
• Advertising that suggests abortion or uses obscene documents and designs
• Medical device advertising that differs from the approved, certified, or reported content
• Advertising that has not undergone self-regulatory review or that differs from the reviewed content
Such acts are subject to the following punishment under Article 52 of the Medical Devices Act.
Article 52 of the Medical Devices Act | Imprisonment for up to 3 years or a fine of up to 30 million won |
Manipulation of Clinical and Non-Clinical Reports and Related Acts
Where an institution designated as a non-clinical testing institution or a quality control review institution falsely prepares or issues a clinical trial result report, a non-clinical test report, or a quality control review report, this constitutes a violation of the Medical Devices Act.
In addition, where a medical device manufacturer, importer, or the like fails to prepare or disclose an expenditure report on the provision of economic benefits, or fails to retain the books and supporting materials related to that expenditure report, the person may also be subject to punishment for a violation of the Act.
Medical Devices Act, Article 53-2 | Imprisonment for up to 1 year or a fine of up to 10 million won |
Joint Penalty Provisions
Where an employee such as a corporation's representative, agent, or staff member commits a violation of law in connection with the business of the corporation or individual, not only the actor but also the corporation or individual is subject to a fine.
However, where the corporation or individual has exercised due care and supervision over the relevant business to prevent the violation, the fine is waived.
3. Violation of the Medical Devices Act | Administrative Disposition
For a violation of the Medical Devices Act, administrative dispositions may accompany criminal punishment.
Various administrative sanctions may be imposed depending on the seriousness of the violation, and because this can have a significant impact on business operations, particular care is required.
The manufacture, import, or sale of a particular medical device may be prohibited, and all or part of the business may be suspended for up to 1 year, so significant constraints may be placed on the business.
Revocation of Designation and Business Suspension
The Minister of Food and Drug Safety may impose revocation of designation or suspension of business on education-providing institutions, clinical trial institutions, nonclinical trial institutions, technical document review institutions, quality control review institutions, and the like.
This applies where designation was obtained by false or improper means, or where a false report was prepared or issued intentionally or through gross negligence.
In addition, an institution whose designation has been revoked cannot be redesignated within 3 years.
Penalty Surcharge Disposition
Even where a business suspension disposition would have to be imposed for a violation of the Medical Devices Act, it may be replaced by a penalty surcharge disposition when there is a concern that it would cause serious inconvenience to the public who use the medical devices or harm the public interest.
A penalty surcharge may be imposed up to 1 billion won, and the amount and method of collection are determined according to the type and degree of the violation.
4. Violation of the Medical Devices Act | Methods of Response
A violation of the Medical Devices Act may lead not only to criminal punishment but also to an administrative disposition.
This may impose serious constraints on business operations, so a prompt and accurate response is needed when a violation occurs.
Responding to an Inquiry
When an investigation relating to a violation of the Medical Devices Act begins, it is important to respond to the investigation actively.
Promptly grasping the internal situation and systematically securing relevant evidentiary materials are essential.
All evidence must be collected lawfully, and the materials should be reviewed thoroughly to prevent unfavorable interpretation.
Filing of an Administrative Appeal
To object to a disposition such as a business suspension or penalty surcharge for a violation of the Medical Devices Act, an administrative adjudication may be filed within 90 days from the date of receipt of the notice of disposition.
▶ How to prepare a written request for administrative adjudication
A written request for administrative adjudication must be prepared in writing, and the request must accurately include the mandatory entries prescribed by law.
• The claimant's name and address, or the address of the office
• The names of the respondent and the administrative appeals commission
• The specific content of the disposition that is the subject of the adjudication request
• The date on which the disposition became known
• The purport and grounds of the adjudication request
• Whether the respondent gave notice of administrative adjudication and its content
※ Where the claimant is a corporation or an unincorporated association or foundation, or where a designated representative or agent files the request, the name and address of the representative, manager, designated representative, or agent must be stated together with the basic entries above.
Filing of Administrative Litigation
If relief could not be obtained even through administrative adjudication, an administrative litigation may be filed within 60 days from the date the written ruling is served.
▶ How to prepare a complaint for administrative litigation
① Information on the parties
• Basic personal details, such as the names and addresses of the plaintiff and the defendant
• If there is a statutory agent, that information is also included
② Object of the claim
The object of the claim is the part that specifically states the holding of the judgment the plaintiff seeks from the court, and it should express the purpose and scope of the litigation concisely and clearly.
③ Cause of the claim
The cause of the claim is the part that specifically states the facts establishing the right or legal relationship the plaintiff asserts.
The facts and legal grounds underlying the claim should be set out clearly.
5. Violation of the Medical Devices Act | Response Strategy and Legal Support
Because a violation of the Medical Devices Act carries strict punishment, not only manufacturers, importers, and distributors of medical devices but also members of the public who do not handle medical devices should thoroughly comply with the relevant regulations.
If a person is implicated in a violation of the Medical Devices Act, an active and prompt response at an early stage is important, and the process of actively presenting the case to investigative authorities through clear materials that can demonstrate the absence of intent is particularly important.
The medical attorneys at our firm have gained extensive experience across various fields of medical devices and healthcare, including legal review related to medical device CSOs, responses to the Ministry of Food and Drug Safety, and advisory on clinical research plans.
If you are facing difficulties from being implicated in a violation of the Medical Devices Act, you may wish to develop a response strategy together with a 🔗medical attorney at any time.
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