CONTENTS
- 1. Suspension of Medical License, What Were the Detailed Circumstances?
- - Suspension of Medical License, What Are the Relevant Statutes?
- 2. Suspension of Medical License, What Was the Court's Determination?
- 3. Suspension of Medical License, Daeryun's Strategy
1. Suspension of Medical License, What Were the Detailed Circumstances?
A, who received the suspension of medical license, is an oriental medicine doctor operating an oriental medicine clinic in Daegu, and it was revealed that over a period of about two years, A disinfected and reused single-use multi-needles (MTS)* on eleven patients.
The Ministry of Health and Welfare determined that A's conduct constituted an 'immoral medical practice' as provided in Article 32, Paragraph 1, Item 2 of the former Enforcement Decree of the Medical Service Act, and imposed a one-month suspension of license.
A filed an administrative lawsuit claiming that the disposition was excessive, stating, "The MTS procedure is not a medical practice, the multi-needles were thoroughly disinfected and reused only once, and no health problems arose for the patients."
* MTS: a treatment method that uses fine needles to enhance the skin's regenerative and recovery capacity
Suspension of Medical License, What Are the Relevant Statutes?
In the above case, the main ground for the suspension of medical license was a 🔗Violation of the Medical Devices Act.
A violation of the Medical Devices Act refers to a violation of the statute enacted to regulate the medical devices used in performing medical practices and to secure the efficient management of medical devices.
■ Acts in Violation of the Medical Devices Act
1. Unauthorized Medical Devices
To manufacture, sell, and import medical devices, one must obtain manufacturing approval and import approval from the Commissioner of the Ministry of Food and Drug Safety.
2. Medical Device Advertising
Falsely advertising or exaggerating the name, manufacturing method, performance, or effects of a medical device constitutes a violation of the Medical Devices Act.
3. Medical Device Rebates
A medical device rebate refers to an act in which a medical device company requests that its medical devices be used and, in return, provides economic benefits to medical personnel and hospitals.
■ Punishment for Violation of the Medical Devices Act
- Administrative Disposition: revocation of approval under the Medical Devices Act, suspension of business, orders to suspend the use and sale of, recall, or dispose of medical devices, penalty surcharge dispositions, and the like
- Criminal Punishment
A person who obtains manufacturing or import approval or certification of a medical device, or files a report, by false or improper means | Imprisonment for up to 5 years or a fine of up to KRW 50 million |
A person who files an investigation report concerning a newly developed medical device by false or improper means | |
A person who uses and distributes an unauthorized medical device | |
A person who obtains a renewal of the valid period of a medical device manufacturing approval or the like by false or improper means | |
A person who violates the regulations concerning clinical trials of medical devices | Imprisonment for up to 3 years or a fine of up to KRW 30 million |
A person who files a report on the repair or sale of a medical device by false or improper means | |
A person who refuses, obstructs, or evades the disposal of medical devices or other necessary dispositions carried out by a public official |
2. Suspension of Medical License, What Was the Court's Determination?
The court did not accept A's argument in the suit seeking revocation of the suspension of medical license.
The court held that "the MTS procedure constitutes a medical practice that requires specialized medical knowledge, because skin damage and the possibility of infection may arise during the procedure."
The court also stated, "Even if the single-use multi-needles at issue do not fall under the single-use injection medical supplies whose reuse is prohibited under the Medical Service Act, the risk of infection upon reuse is high, and therefore A's conduct constitutes an immoral medical practice."
With respect to A's argument that the Ministry of Health and Welfare had deviated from or abused its discretionary power, the court likewise found that "medical practices directly bearing on the life and health of the public require a high degree of legal compliance," and that "considering the number of times A reused the multi-needles, the duration, and the possibility of infection, the degree of illegality is by no means slight," and accordingly determined that the disposition was not excessive.
3. Suspension of Medical License, Daeryun's Strategy
We analyzed the judgment of the Administrative Court, which found that, in the suit seeking revocation of a disposition brought by an oriental medicine doctor who received a suspension of medical license, the reuse of single-use needles was an immoral medical practice and that the suspension disposition was justified.
Because the Medical Devices Act incorporates extensive and complex medical knowledge, difficulties may arise in interpreting its provisions and in confirming whether a violation has occurred. When facing allegations of a violation of the Medical Devices Act, a review of the facts and confirmation of the matters at issue are therefore important.
At the 🔗Medical Litigation Group of Daeryun Law Firm LLP, attorneys experienced in medical matters, drawing on their experience working at medical-related institutions, form a task force and present step-by-step solutions.
If you need a consultation with an attorney experienced in matters relating to the Medical Devices Act, you are welcome to schedule a 🔗legal consultation with Daeryun Law Firm LLP.
