Press Coverage

A 40-year-old woman who was indicted on charges of hiding property to avoid compulsory execution due to default was acquitted after proving that there was no intention to conceal it. According to the legal community on the 22nd, the Seoul Central District Court acquitted a person in her 40s who was sent to trial on charges of evasion of compulsory execution on the 9th of last month. Person A was accused of hiding 25 million won for one year from 2020 for the purpose of avoiding compulsory execution due to debt. handed over to trial. Previously, the court had decided to pay Mr. A's loan to creditors and register him on the list of defaulters. The prosecution determined that Mr. A hid his assets by transferring them to his partner's bank account when he received salary, etc. into an account in his name. In addition, during this process, it was determined that Mr. A had applied for rehabilitation by taking advantage of the fact that his total assets had decreased. However, Mr. A denied the charges, saying that he had sent living expenses to his housemate, and that he had also received money from his housemate when he was short of money. He also claimed that he had no intention of hiding his assets because he submitted all of his salary ledgers and account transaction details to the court when going through rehabilitation procedures. The court ruled that the amount Mr. A sent to his housemate could not be considered excessive for the living expenses of two adults, and that it was an economic community that exchanged money with his housemate depending on their economic situation. Even when going through rehabilitation procedures, it was judged that the decision was made by submitting detailed usage details of the transfer amount to the court. Attorney Kim Won-sang of Daeryun Law Firm, who represented Mr. A, said, “If Mr. A had intended to harm his creditors, he would not have received his salary in cash and created account transfer details, but it appears that the court found him not guilty based on the fact that he did not do so and submitted the account transfer details as is to the rehabilitation court.” Reporter Jeong Cheol-wook[View full article] A man in his 40s who gave living expenses to a housemate was indicted for ‘evading compulsory execution’… Court found not guilty with no intent to conceal (link)

A man who was handed over to the prosecution on charges of leaking important company information to a third party was acquitted. In March, the Daejeon District Prosecutors' Office decided not to indict Mr. A, in his 40s, on charges of breach of trust and fraud. Mr. A worked as a local branch manager for a sales company for about 1 year and 6 months starting in October 2023, and was charged with causing about 83 million won in damage by passing on data necessary for the company's business to a third party. Mr. A denied the charges. He claimed that he had joined the company after receiving a recommendation from Mr. B, the head of the regional center, and that the company was only in charge of salary management and had no knowledge of the existence of the leaked data. The prosecution decided not to indict. This is because Mr. A did not sign a business contract with the head office. As the basis for this, the prosecution mentioned the 'commissioning contract' signed between center director B and the head office. The contract contained the clause that 'all workers at the center belong to Mr. B, and Mr. B will assume responsibility in the event of a legal dispute.' The prosecution explained, "Since Mr. B had all rights to the company's data, it is difficult to view Mr. A as 'a person handling other people's affairs.'" Attorney Choi Hyeon-deok of Daeryun Law Firm, who represented Mr. A, said, "For a breach of trust to be established, a 'person handling another person's affairs' must cause property damage to the other party by acting in violation of his/her duties." He explained, “It must be acknowledged that Mr. A was directly managed and supervised by the company, and the actual person handling the matter was Mr. B, so it does not meet the requirements for breach of trust.” Reporter Hwang Jeong-won (jwhwang@mt.co.kr)[View full article] The branch manager accused of leaking company information was not indicted... The reason (shortcut)

Daeryun Law Firm announced on the 21st that it recently signed a business agreement with Kim & Co., CPA PC GROUP, a public accounting firm headquartered in Los Angeles, USA. The purpose is to strengthen cross-border advisory competitiveness and speed up entry into the global legal market. Based on this agreement, Daeryun plans to advance customized tax, accounting, and legal services for corporate and individual customers in the U.S. and establish a complex advisory system capable of comprehensive response across borders. The agreement ceremony was held at Daeryun Law Firm's Seoul headquarters branch office on the 16th, and Daeryun representative attorney Park Dong-il, U.S. attorney Kim Mia, and Kim Seong-gu The CEO of Kim & Co. Certified Public Accounting Firm, etc. attended. Kim & Co. Certified Public Accounting Firm has been providing non-immigrant investment advisory services such as ▲ U.S. federal and state tax law advice ▲ support for preparing financial statements according to accounting standards ▲ local business incubation in the U.S. ▲ E-2 visa, etc. to companies doing business in the U.S. and Korea. It has an online-based computer system, including video consultation, to provide services without time and space constraints. According to the agreement, the two companies cooperate in ▲establishment and licensing of a corporation in the United States ▲international tax and accounting advice ▲investment and visa consulting ▲joint response to cross-border legal issues between Korea and the United States ▲development of customized integrated solutions ▲establishment of an online joint consultation system. Kim & Co. CEO Kim Seong-gu said, “Through collaboration with Daeryun, “We have laid the foundation for providing broader and more precise advice to our customers,” he said. “We will carefully analyze the U.S. tax law system, which differs by federal and state governments, and prepare effective strategies based on this to actively support our customers’ entry into the global market.” Daeryun Park’s representative attorney, Park Dong-il, said, “In the era of global advisory, organic collaboration is more important than individual response, and this agreement will allow us to proactively manage our customers’ legal and tax risks and support substantial growth by combining the expertise of both companies. “I look forward to it,” he said. Meanwhile, Daeryun plans to open a U.S. office at One World Trade Center (1WTC) in Manhattan, New York, as early as June and begin operating a global local base. Reporter Jeong Cheol-wook[View full article] Seoul Shinmun - Daeryun Law Firm and Kim & Co., a public accounting firm in the U.S., signed an MOU... Strengthening cross-border advisory capabilities (link) Tax and Finance News - Daeryun-US Kim & Co. business agreement... Cooperation in corporate establishment, licensing, international taxation and investment consulting, etc. (Go here) Jose Ilbo - Daeryun Law Firm signs MOU with KIM&CO of the United States... Strengthening the position of a global mega law firm (Click here) Venture Square - Daeryun Law Firm signs a business agreement with Kim & Co. Certified Public Accounting Firm (Go here)

Conducting its own survey of 3,800 clients Daeryun said, “We will strengthen customer-centered legal services by increasing expertise in case handling, including AI-based analysis.” While competition among law firms, including law firms, is intensifying as the number of lawyers increases recently, there is a law firm that has achieved high customer satisfaction and is attracting industry attention. According to the legal community on the 21st, Daeryun Law Firm recently conducted a survey of 3,800 clients who entrusted cases to Daeryun. As a result, 98% of respondents responded that they were ‘satisfied.’ According to Daeryun, when the results became known, customers who used Daeryun in related communities and cafes left reviews saying, “I was not frustrated at all because they provided detailed guidance throughout the process and immediately explained any questions I had.” In fact, Daeryun has its own customer management team and is implementing ‘communication-centered close service.’ In addition, we are creating and operating functional organizations such as the Customer Satisfaction Center, Litigation Management Headquarters, and Special Action Headquarters, as well as an AI-based case analysis system. A Daeryun official explained, "Most legal service users are not familiar with complex legal procedures and feel anxious during the case handling process," and added, "Only a law firm with a smooth communication system throughout the entire case handling process like Daeryun will have a great advantage in building trust with users." Daeryun CEO Kim Kuk-il said, "The essence of legal services is ultimately the essence of legal services. “What moves people is trust. Therefore, high-quality legal services begin with alleviating customer anxiety and gaining trust,” he said. “Daeryun will continue to improve the quality of legal services and strengthen customer-centered services so that customers can handle their cases with peace of mind from start to finish.” Meanwhile, the number of lawyers has increased significantly since the introduction of the law school system. According to the Korean Bar Association, the number of registered lawyers, which was around 10,000 in 2009 before the introduction of law schools, nearly tripled to about 36,000 last year. Some are pointing out that as excessive competition for commissions continues due to the increase in the number of lawyers, "the majority of law firms are only interested in the appointment stage and are often negligent in responding thereafter." Reporter Junho Yoon delo410@kyeonggi.com[View full article] The era of law firm competition... Daeryun Law Firm, most customers responded ‘satisfied’ (click here)

Daeryun's lawyer said, "You have betrayed social responsibility and public trust... We will hold you accountable to the end." In relation to the controversy over SK Telecom (SKT)'s delayed response to the hacking incident, the police summoned the accuser on the 21st. Seoul Namdaemun Police Station summoned attorneys Son Kye-jun and Cheon Jeong-min from Daeryun Law Firm, who had accused SKT CEO Yoo Yeong-sang and SKT security chief of breach of trust and obstruction of official duties, on the afternoon of the same day to find out the details of the complaint. Lawyer Son held a press conference at the main gate of the police station prior to the investigation and said, "The SKT hacking leak incident is the worst security incident in telecommunication history," and added, "I hope that the facts will be clearly revealed through a thorough investigation into the fact that it has betrayed its social responsibility and public trust as a key telecommunication company." He argued, “2,220 won per person is low, and if you multiply it by the number of subscribers, which is about 24 million, SKT has made unfair profits of 54 billion won through breach of trust.” Attorney Son emphasized, “I have no intention of withdrawing the complaint, and I will hold him accountable to the end.” When asked by reporters whether he thought SK Chairman Choi Tae-won was responsible for this incident, Attorney Cheon said, “(SKT) Corporation. “The CEO who can be confirmed in the register is not Chairman Chey Tae-won, so it was difficult to hold him criminally responsible,” he said, and explained that no plans have been decided for future complaints. Previously, Daeryun said, “SKT was aware of the need to process affairs related to the storage and use of users’ SIM-related information, but neglected management,” and submitted a complaint to the Namdaemun Police Station on the 1st. Regarding suspicions about the timing of SKT’s hacking recognition and reporting time, it also said, “An appropriate initial response from government agencies was required.” It was a serious violation of the law that interfered with the law.” On the 23rd, the Namdaemun Police Station will also conduct an investigation into the complaint filed by the Common People’s Livelihood Countermeasures Committee against Representative Yoo and Chairman Choi. The Common People's Committee claimed that Chairman Choi and others violated the Personal Information Protection Act and the Information and Communications Network Act by delaying reporting even after knowing about the hacking. Separately, the Cyber ​​Investigation Unit of the Seoul Metropolitan Police Agency is conducting an investigation to trace the background to this hacking incident. Juntae Kim (readiness@yna.co.kr)[View full article] Yonhap News - Police summon accuser for 'suspicion of delayed response to SKT hacking' (comprehensive) (link) TV Chosun - Police summon accuser for 'suspicion of delayed response to SKT hacking incident' (link) SBS Biz - Police summon accuser for 'suspicion of delayed response to SKT hacking incident' (link) TJB Daejeon Broadcasting - Police summon accuser for 'suspicion of delayed response to SKT hacking incident' (link) SBS - 'SKT hacking' accuser appears at investigation... “54.5 billion won in unfair profits (link)” Newsis - Police begin investigation into SKT SIM hacking... Summon the accuser (link) NewsPim - Police summon accuser of 'SKT hacking incident'... “The worst security incident in history” (link) Money Today - Police begin full-fledged investigation into SKT management for ‘USIM hacking’ (Click here) News 1 - Police summons accuser for 'suspicion of delayed response to SKT SIM hacking' (link) YTN - Investigation of SKT accuser of 'USIM information leak'... "54.5 billion won in unfair profits" (link) Edaily - ‘SKT hacking’ lawsuit battle begins in earnest… The accuser said, “There was not enough prevention” (link) Hankook Ilbo - Police begin investigation into management of 'SKT hacking incident'... Investigating the complainant (link) The Fact - Police investigate SKT hacking accuser... “Estimated amount of breach of trust is 54 billion won” (link) Segye Ilbo - Police begin full-scale investigation into suspicions of delayed response to SKT SIM hacking... Summon the accuser (link) New Daily - Police summon accuser of 'SKT hacking incident'... “Delay in reporting even after being aware of hacking” (Shortcut) Financial News - Police begin full-fledged investigation into ‘SKT hacking incident’… Investigating the complainant (link) Nocut News - "The worst security incident in telecommunication history"... Police investigate accuser of ‘SKT SIM hacking’ (Click here) Empathy Newspaper - SK Telecom's worst hacking incident... The background to the security issues revealed by the police investigation (link) Korea Duty Free News - Police summon accuser over suspicions of delayed response to SKT hacking incident (Click here) Shin-A Ilbo - Police summons and investigates lawyer accused of 'SKT's delayed response to SIM hacking' (link) KBS - Police investigate accuser regarding suspicions of ‘SKT’s delayed response to hacking’ (Click here) Kyunghyang Shinmun - Police summon accuser for ‘suspicion of delayed response to SKT hacking’ (link) Herald Economy - Taking aim at SKT executives who were robbed of their SIM cards... Police summons and investigates accuser of ‘hacking incident’ [World&] (Shortcut) Yonhap News TV - Police summon accuser for 'suspicion of delayed response to SKT hacking incident' (link) The Hankyoreh - SKT SIM replacement ‘online reservation’ has been confusing for a month… Subscriber's Displeasure (Shortcut) Busan Ilbo - Police begin full-scale investigation into SKT hacking incident (Click here) OBS - Police fully investigate 'SKT hacking incident'... Summon the accuser (link) Weekly Today - [Weekly Today] Police investigate 'SKT SIM hacking incident' in earnest...summon the accuser (link) NSP News - Controversy over ‘poor response’ to SKT SIM hacking… Police begin investigation into complainant (link) MBC - Police investigate accuser of 'suspicion of delayed response to SKT hacking' (link) The Public - “via China, using North Korean IP range”... Spreading suspicions that North Korea is behind SKT hacking (link) Yonhap News TV - Investigation into 'SKT SIM hacking' management begins... Investigation into the background of hacking (link) Segye Ilbo - “SKT Leaked Information, Circumstances Flowing to Singapore” (Shortcut) Tomorrow Newspaper - Police summon accuser for ‘suspicion of delayed response to SKT hacking’ (link)

Following the complaint and accusation on the 1st, an additional supplementary statement of reasons was submitted. “Information protection investment per subscriber is 3,531 won… lower than the average of other telecommunication companies.” The complainant will be investigated at Namdaemun Police Station in Seoul at 3 p.m. on the 21st. Regarding the leak of SIM card information from SK Telecom (SKT), law firm Daeryun Law Firm filed a complaint and accusation against those responsible early this month, and submitted an additional supplementary statement of reasons, urging the police to conduct a speedy investigation. The law firm Daeryun announced on the 20th that he submitted a complaint and a supplementary reason for complaint to Namdaemun Police Station in Seoul, which is currently in charge of the investigation related to the SKT incident. Previously, on the 1st, Daeryun filed a complaint against SK Telecom's CEO Yoo Young-sang and security manager on charges of breach of trust and obstruction of official duties. This is because, although they were aware of the importance of storage and use of SIM-related information, they neglected management, and even after first recognizing abnormal signs in the in-house system, they belatedly 'reduced and falsely reported' it to the Korea Internet & Security Agency. In this additional supplementary statement, Daeryun pointed out that although SKT had the largest number of subscribers, it has spent a smaller amount of information protection investment than KT since 2019. In particular, KT It was pointed out that unlike LG U+, which increased its information security investment by about 19.6 billion won in 2024 compared to 2022 and invested an additional 33.9 billion won, SK Broadband Co., Ltd. went against the trend of the times by only increasing its budget by about 3.3 billion won. In addition, as of December last year, SKT's information security investment per subscriber was 3,531 won, compared to the other two. It was explained that it did not even reach the average of 5,751 won for telecommunication companies (KT, LG U+). At the same time, Daeryun emphasized that SKT Corporation was guilty of breach of trust by not complying with its obligation to manage and utilize customers' SIM information and earning profits worth a total of at least KRW 54.5 billion (= KRW 2,200 He also pointed out the fact that it was not encrypted. Lawyer Dae-ryun Son Gye-jun said, “The Korea Internet & Security Agency was able to confirm that official work was scheduled to request on-site investigation and to request preservation of data and submission of documents to confirm the accident.” He said, “The obstruction of the execution of official duties by hierarchies is clearly proven.” Seoul Namdaemun Police Station plans to conduct an investigation into the accuser at 3 p.m. on the 21st, and Daeryun attorneys Son Gye-jun and Cheon Jeong-min will participate. Daeryun CEO Kim Kook-il said, “Daeryun is currently preparing a class action lawsuit by gathering victims related to the SKT incident, and thousands of inquiries have already been received.” He added, “Victims will receive practical relief through civil and criminal responses, and those responsible for this incident will be identified. “We will do our best until the end to ensure that he receives appropriate punishment.” Reporter Park Jae-gwan (paksunbi@fnnews.com)[View full article] Financial News - Dae-Ryun “SKT’s business malpractice amount is at least KRW 54.5 billion… Going against the grain of the times” (Shortcut) Aju Economic Daily - [Law Firm Lounge] Dae-Ryun "SKT's malpractice amount is at least KRW 54.5 billion... going against the grain of the times" ​​​​​​​ (Shortcut) Digital Times - Police begin investigation into accusation of executives and security managers in ‘SKT hacking incident’ (Go here) Korea Economic Daily - SKT subscribers only receive '3,000 won' per person... Investment in information security ‘poor’ (link)

When a couple with minor children divorces, there is an issue that is as fiercely contested as alimony. It is a custody dispute over who will raise the child. Parenting is a serious issue that can affect a child's life, so it is carefully decided based on various data. There is something that many couples say when claiming custody. It means ‘you take better care of your child than the other person.’ However, this is a misunderstanding, and the court judges based on the ‘welfare of the child’ rather than the parents’ claims. Simply put, rather than considering who loves the child more, it is important to consider who has made a more substantial contribution to raising the child and whether they can provide a stable environment as well as an emotional environment in the future. Therefore, in order to claim custody, you need objective evidence that you put more effort into raising the child. For example, this includes parenting diaries or photos containing records of helping your child go to and from school or visiting the hospital with them. It is also important to emphasize that a stable job or high income level can provide a good economic and emotional environment for your children. In addition, if the child is enrolled in school, school records, comments from the homeroom teacher, and records of after-school activities may also be included as evidence. Conversely, if there are reasons for which it is difficult to claim custody from the other party, materials that can prove unfavorable circumstances may be submitted. For example, it explains that there may be problems in parenting due to frequent drinking, violence, or long absences. An issue that must be addressed along with child custody is child support. However, child support is also an area with many disputes, so negotiations often become difficult. Accordingly, the Seoul Family Court provides a 'child support calculation standard table' to minimize conflict, which is based on the parents' combined pre-tax income and the child's age. However, this is only a reference in case child support cannot be agreed upon, and the court makes a decision considering the specific circumstances of the couple. In addition, even if the divorce occurred without any agreement on child support, it is possible to claim 'past child support' for raising the child alone from the time of divorce, as well as 'future child support' required until the minor child becomes an adult. Lawyer So-young Kwak of Daeryun Law Firm in Cheonan said, "The important thing in custody and child support disputes is to make logical arguments centered on the rights of the child. Emotional actions such as a strong will to raise children or blaming the other party do not help resolve the dispute. However, due to the nature of divorce litigation, it is very emotionally draining, so there is a high possibility of not understanding complex standards and procedures or making incorrect judgments. Therefore, custody can be obtained with the help of a divorce lawyer. “We will need to come up with a legal plan and strategy,” he said. Reporter Jin Ga-young (lawissue) (news@lawissue.co.kr)[View full article] How to respond to divorce custody and child support disputes explained by a lawyer (link)

A woman in her 20s who was indicted on charges of receiving cash from voice phishing victims and delivering it to a criminal organization was acquitted. According to the legal community on the 20th, the Gwangju District Court found Ms. A, a woman in her 20s, not guilty, who was put on trial on fraud charges on the 23rd of last month. Ms. A was accused of receiving about 180 million won from five voice phishing victims in 2023 and passing it to related gang members. The prosecution determined that Mr. A had conspired with a voice phishing organization and acted as a collection agent. However, Mr. A denied the charges, saying that a member of the voice phishing organization approached him impersonating a trust company official after seeing his resume posted on a job search site. He also argued that the trust company in question was easily searched on the Internet, so it was difficult to suspect that it was a crime. In addition, Mr. A also emphasized that he felt suspicious while carrying out cash delivery work and immediately went to the investigative agency and surrendered himself. "The transaction method, such as receiving a significant amount of money without any communication, is difficult to see as a normal form of transaction, so there is suspicion that the defendant acted as a collection device while knowing that it was a crime." However, "The amount the defendant received was about 2 million won, which cannot be considered an excessively large amount of money, and when a crime was suspected, he refused instructions from a voice phishing organization. If he had even vaguely known that he was participating in a fraud, he would not have turned himself in." Daeryun Law Firm, which represented Mr. A, stated the reason for sentencing. Attorney Kwak Min-seop said, "Mr. A gave his real name in the process of receiving money from the victims, and paid for transportation and food expenses using a card in his name. Since there was no intention to commit fraud, he did not do anything to obscure his identity, and the court appears to have acknowledged this and ruled him not guilty." Jeong Eui-jin (jej88@ikbc.co.kr)[View full article] 'Voice phishing collection plan' Woman in her 20s found not guilty..Why? (Shortcut)

Daeryun Law Firm will hold a seminar on ‘Response to the Regular Foreign Exchange Inspection System’ at the Korea Medical Device Industry Association training center at 1 p.m. on the 26th. The seminar is co-hosted with the Korea Medical Device Industry Association, and anyone, including members of the Korea Medical Device Industry Association and Daeryun Pharmaceutical and Bio industry customers, can participate for free. The Korea Customs Service announced that starting this year, it will conduct ‘regular foreign exchange inspections’ every five years for companies above a certain size. Import/export companies need to conduct detailed internal inspections and establish compliance systems, and intensive crackdowns are expected on specific industries such as the medical device and beauty industries. Myeong Jae-ho, Daeryun, customs expert, will give a presentation on customs investigation trends and compliance obligations under the Foreign Exchange Transactions Act by transaction type. In addition, it introduces the risks and response strategies that companies that export and import medical and beauty devices may face if they do not comply with the Foreign Exchange Transactions Act during the transaction process. Expert Myeong has worked at a customs corporation and numerous companies and has performed import and export customs clearance, trade screening, and customs trade consulting. He was recognized for his expertise by working as a full-time lecturer at the Korea Customs Service's YES FTA, an export review committee member at the Defense Acquisition Program Administration, and a CP evaluation committee member at the Strategic Materials Management Agency. Daeryun Kim Kook-il, CEO of Management, said, “With the introduction of the regular foreign exchange inspection system, the scope of legal obligations that companies must comply with, including the Foreign Exchange Transactions Act, has expanded. We hope that through this seminar, companies will be able to proactively check risks and prepare effective response strategies.” Companies wishing to participate can apply through the Daeryun website by the 23rd.[View full article] Tax and Finance News - Daeryun, target for medical, pharmaceutical and beauty device companies on the 26th... Regular Foreign Exchange Inspection Response Seminar (Go here) Sejeong Ilbo - Daeryun Law Firm held a seminar in response to the ‘regular foreign exchange inspection system’ on the 26th (link) Segye Ilbo - Daeryun Law Firm holds ‘Regular Foreign Exchange Inspection System Response Seminar’ for import and export companies (Go here) International News - Daeryun Law Firm held 'Regular Foreign Exchange Inspection System Response Seminar' on the 26th (Go here) Pharmacy News - Medical Device Industry Association introduces ‘foreign exchange inspection risk response strategy’ to the medical device and beauty device industry (link) Hans Economy - Korea Medical Device Industry Association holds ‘Regular Foreign Exchange Inspection Preparation Seminar’ (Go here) Palm News - Korea Medical Device Industry Association introduces ‘Foreign Exchange Inspection Risk Response Strategy’ for the medical device and beauty device industry (link) Medical Newspaper - Medical Device Association holds a seminar in preparation for regular foreign exchange inspection (link) Health News - Medical Device Industry Association holds a seminar in preparation for regular foreign exchange inspections (Go here) Laportian - Medical Device Association held ‘Regular Foreign Exchange Inspection Response Plan Seminar’ on the 26th (Go here) Newsis - "Response to foreign exchange inspection risks"... Medical Device Industry Association and Daeryun join hands (link) Daily Medi - ‘Seminar on countermeasures for regular foreign exchange inspection’ on the 26th of this month (link)

Attorney Daeryun Lee Il-hyung "special legal character...Establishment of an independent system distinct from existing medical device laws"business license, clinical trial, Performance evaluation, advertising regulations, Real-world evaluation,In a previous contribution, the contributor looked at the growth potential of the digital medical device market and said,, ‘Digital Medical Products Act’ Explained the necessity of the enactment and the purpose of the legislation.. In particular, it emphasizes the characteristics of digital medical technology that are difficult to include in the existing medical device law system., It has been pointed out that the establishment of an independent regulatory system was inevitable.. The Digital Medical Products Act, enacted against this background, has its own legal system that is distinct from existing laws.. Below, we will focus on the overall framework and legal system of the Digital Medical Products Act.. 1. Relationship between the existing legal system and the Digital Medical Products Act Digital Medical Products Act(Briefly below ‘Dongbeop’)is a medical device under the existing legal system., In vitro diagnostic medical devices, medicine, Products that were classified as industrial products, etc. are converted into digital medical devices., Digital convergence medicine, It is reclassified and defined as digital medical and health support devices.. for example, Before the enactment of this law AI Diagnostic software with applied technology is considered a medical device under the Medical Device Act., Digital convergence medicine is a pharmaceutical and/Or, it is regulated as a medical device under the Medical Device Act, but, Under the Digital Medical Products Act, all ‘digital medical products’, Among them, each ‘digital medical devices’ and ‘Digital convergence medicine’It is stipulated that. Below, in accordance with the Medical Device Act, ‘medical device’definitions and regulations of ‘Digital Medical Products Act’ By comparing definitions, Let’s take a closer look at the differences in concept between the two laws.. As can be seen from the comparison table above, the law ‘digital technology’(Intelligent information technology, robot technology, Advanced technologies prescribed by Prime Minister’s Ordinance, such as information and communication technology)The phrase is key.. in other words, This law stipulates medical devices using digital technology., Convergence medicine, medical treatmentㆍHealth support devices are defined as digital medical products.. The existing legal system, the Medical Device Act,, Looking at the relationship with the Pharmaceutical Affairs Act, The Digital Medical Products Act functions as a kind of special law., ‘digital technology’If the unique requirements of. the other side, to the product ‘digital technology’If this is not included, existing medical device laws, Pharmaceutical Affairs Act, In vitro diagnostic medical device method, Or, it would be easier to understand that laws related to industrial products apply.. Meanwhile, among digital medical products ‘digital medical devices’Regarding whether it applies to, You can easily make a decision by using the chart below attached to the guidelines published by the Ministry of Food and Drug Safety.. 2. As explained earlier, the regulatory system of this law is different from the existing law., The background to the enactment of this law is 'digital technology'This is because the existing legal system has limitations in effectively regulating this new technology due to its characteristics that distinguish it from existing medical devices.. for example, Because digital medical device software does not exist in physical form,, According to the existing medical device law ‘seal’ There is no need to apply relevant regulations. also, In the case of digital medical products, the performance of the finished product can be predicted relatively accurately when made by combining proven components.. This law reflects these characteristics, e case ‘seal’ Without applying relevant regulations, In the latter case, it is stipulated that the licensing process can be simplified if the finished product is designed only with verified elements that have undergone component performance evaluation..As such, this law was designed to have an independent regulatory system that is different from existing laws., An overview of the main differences from the existing regulatory system is as follows.. Business license management: Introducing a separate business licensing system that reflects the characteristics of digital technology -Digital medical device manufacturing business that manufactures or imports digital medical devices ㆍ Establishment of new import industry regulations(Same law8article, my12article)-Special provisions regarding the sale of stand-alone digital medical device software(Same law27article) Streamline clinical trials: Introduction of simplified clinical trial procedures reflecting the characteristics of digital technology-IRB and the scope of clinical trials that require approval from the Minister of Food and Drug Safety are expected to differ.(Prime Minister's Decree). -Allows for new types of clinical trials, such as data-based clinical trials(Same law9Preparation5port) Component performance evaluation: Establishment of a component performance evaluation system to reflect the characteristics of digital medical products, which often consist of multiple components -The Minister of Food and Drug Safety can evaluate the performance of components that may affect the function of digital medical products, such as sensors and artificial intelligence algorithms. -If the license applicant constructs a finished product using only components for which performance evaluation has been completed, ‘Simplification of licensing procedures’You can receive the benefit of(Same law40Preparation1From clause 1 to 13port, my5term, etc.). Benefits of Excellent Management System Certification -currently being discussed 'Regulations on digital medical product licensing, certification, reporting, review and evaluation, etc.'According to, Same law17Preparation3Manufacturers who have received good management system certification pursuant to this clause may receive special privileges.. (specifically, legislation24pharmacy1Antibiotics4Materials corresponding to the 'Information about the product(model design, Input/output data, development information, etc.)', 'Actual use evaluation plan', 'Actual use evaluation result report'It is expected that it will be possible to submit it in place of ..) Establishment of new regulations related to professional software -For professional software “For professional use” mark, Sales channel, Regulations on advertising methods, etc.(Same law21From the first to the third23article) In the case of stand-alone digital medical device software, exceptions to some provisions of the Medical Device Act are recognized.: Clarifies that unnecessary regulations do not apply to standalone software -Regarding stand-alone digital medical device software, ‘Medical Device Act’ my13pharmacy2port(Obligation to report production performance of medical devices, etc.), my18condolences5(Open sales prohibited), my19article(Scope of application for medical devices, shape or structure, Test specifications, Standard specifications for written information, etc.), my25condolences5(seal), my29From the first to the third31Until the moment(Medical devices subject to tracking management, Creation and Retention of Records, Side Effect Management), my31condolences2(Report on medical device supply details, etc.), my31condolences5(Report on the discovery of foreign substances in medical devices, etc.) and first49article(Renewal of manufacturing license, etc.)does not apply. -In addition, considering the characteristics of stand-alone digital medical device software, 「Medical Device Act」The same also applies in cases where the Minister of Food and Drug Safety recognizes that it is appropriate not to apply.(Same law28article). Real-world evaluation -Regarding actual use evaluation, Despite the rebate-related provisions of the Medical Device Act, a significant exception provision has been established to provide digital medical devices.. Furthermore, digital medical device manufacturers, etc. are also given the benefit of being able to use actual use evaluation data in various approval procedures.. -Digital medical device manufacturers, etc. collect data in the process of actually using digital medical devices.ㆍEvaluate the safety and effectiveness of digital medical devices based on the generated information(below “Real-world evaluation”It is called)can do(Same law15Preparation1port). -Digital medical device manufacturers, etc. who wish to conduct an actual use evaluation must collect the data necessary for the actual use evaluation. 「Medical Device Act」 my13pharmacy3Notwithstanding the provisions of this Article, medical practitioners or those who establish medical institutions within the scope prescribed by Ordinance of the Prime Minister.(Representative or director of a corporation, Also includes those engaged in this.) Digital medical devices subject to evaluation may be provided to medical institution workers. In this case, digital medical device manufacturers, etc. may request medical personnel, medical institution founders, and medical institution workers who use the digital medical devices subject to evaluation to view records of use of the digital medical devices or provide copies thereof.(Same law15article). -The Minister of Food and Drug Safety provides actual use evaluation data submitted by digital medical device manufacturers, etc.8pharmacy3Manufacturing license according to paragraphㆍManufacturing CertificationㆍManufacturing report, my11Permission for change according to ArticleㆍChange CertificationㆍReport change, my12pharmacy2Import permission pursuant to paragraphㆍImport CertificationㆍCan be used for import declaration, etc.(Same law15Preparation3term, etc.). 3. Summary Since the Digital Medical Products Act has a special legal nature, ‘digital technology’If this applies, this Act shall apply.. This Digital Medical Products Act reflects the characteristics of digital technology and is building an independent system that is distinct from the existing medical device law.. specifically, business license, clinical trial, Performance evaluation, advertising regulations, Real-world evaluation, It has unique regulations such as component-based licensing.. Meanwhile, as mentioned at the beginning, Because the contents of the Digital Medical Products Act are so extensive, it was not possible to summarize all the contents in this article.. In the next series, we plan to cover detailed provisions and practical explanations in depth., We urge pharmaceutical company practitioners to continue to pay attention.. I would like to end this contribution here.. [View full article] [Contribution 2] Explanation of the ‘Digital Medical Products Act’ for pharmaceutical practitioners - Focusing on the revised law system (Shortcut)