Press Coverage

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)

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)

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)

Police point to air conditioner as cause of fire Insurance company says, "Insurance company must compensate for insurance money paid" Court says, "Prevention measures alone cannot prevent" If a fire occurred due to a defect in an air conditioner, the court ruled that the installer cannot be held responsible. On the 2nd of last month, the Western Branch of the Busan District Court ruled in favor of the plaintiff in a lawsuit for non-existence of debt filed by a man in his 30s, Mr. A, against insurance company B. Mr. A, who worked as an air conditioner installation engineer, installed an air conditioner in an apartment in the area in 2020. installed. The problem arose two years later when a fire broke out in this apartment. At the time, Company B paid insurance money to the victim, but then suddenly claimed 40 million won in compensation from Mr. A. Based on the results of a police investigation that pointed to the air conditioner as the cause of the fire, Company B claimed that Mr. A did not take fire prevention measures when installing the air conditioner. On the other hand, Mr. A refuted that the cause of the fire was ‘tracking (a phenomenon in which sparks occur from moisture, dust, etc. in the area where electric current flows).’ At the same time, he emphasized that the old age of the product and the user's negligence in management led to the fire. The court ruled in Mr. A's favor. The court said, “When installing an air conditioner, the plaintiff needs to prevent tracking, such as preventing corrosion of terminals due to moisture and poor contact,” and added, “The air conditioner the plaintiff installed at the time was already well past its expiration date, and there was a lot of moisture inside the air conditioner connection box.” It also added, “Since tracking cannot be completely prevented with preventive measures when installing an air conditioner, it cannot be said that the accident occurred due to the plaintiff’s negligence.” Daeryun Law Firm, which represented Mr. A. Attorney Jeong Woo-young explained, “If the debtor claims to deny the cause of the debt in a lawsuit to confirm the existence of a financial debt, the creditor has the responsibility to prove the right relationship. Company B claimed that Mr. A did not fulfill his obligation to explain regular inspection and cleanliness to the user, but the court judged that it would be difficult to admit that this caused the fire.” Digital Content Team[View full article] Claiming compensation from the air conditioner installer who “did not prevent the fire”… Law “No fault” (Shortcut)

In addition to the unpaid amount, he is also responsible for damages due to contract termination, and he also engages in abusive behavior such as verbal abuse against employees. The court ruled that contact with other companies during the contract was caused by the defendant's illegal actions...there is no problem with the plaintiff's claim. The court ruled that damages must be compensated for the social commerce company that 'abused the company'. It was cited as the reason for imposing unfavorable conditions on companies that signed logistics contracts or failing to properly pay outstanding payments. On the 11th, the Namyangju Branch of the Uijeongbu District Court ruled in favor of the plaintiff in a lawsuit filed by logistics company A against fashion social commerce company B, including the settlement amount. Previously, company A signed a logistics contract with company B in August of last year. After signing the contract, Company A carried out work as specified in the contract, but Company B continued to point out neglect of work as a problem. In addition, Company B was found to have engaged in abusive behavior, such as arbitrarily setting deadlines and verbally abusing Company A's employees when they could not meet them. In addition, circumstances were discovered in which Company B deceived Company A by preparing a new contract with another logistics company even though it was under a contract with Company A. In the end, it could no longer endure such abuse of power. Unable to do so, Company A notified Company B of the contract termination in September of the same year. However, Company A was unable to receive payment of the outstanding logistics fee from Company B. Accordingly, Company A filed a lawsuit, saying, "The contract was terminated due to Company B's negligence. Please pay approximately 16 million won, including the unsettled amount, etc.". Also, at the time, Company A spent costs such as recruiting new employees to fulfill the contract, and requested compensation for this additional money as well. It is claimed that damages occurred due to termination of the contract. The court also deemed Company A's claim to be justified. The court ruled that the plaintiff suffered due to the defendant's unreasonable demands, which led to the termination of the contract and caused financial loss. Attorney Kim Ho-jeong of Daeryun Law Firm, the legal representative, explained, "Company B committed illegal acts such as making unreasonable demands and interfering with the settlement process. In addition to abuse of power, Company B also had noise in the payment settlement process. This was because the settlement was made based on a file containing distorted information and many items were omitted." “This can be seen as liability for illegal acts under Article 389, Paragraph 3 and Article 210 of the Commercial Act,” he said. “Therefore, we have an obligation to compensate for not only the settlement amount but also related expenses, such as hiring new employees to handle the increased workload due to the contract.” Reporter Kim Jong-cheol (jckim99@sportsseoul.com)[View full article] Social commerce company that ‘abuses power’ is held liable for damages (Click here)

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)

Daeryun Law Firm announced on the 19th that it signed a medical law violation prevention and compliance advisory business agreement with Hyomin Medical Foundation, a medical corporation, at its Daegu branch office on the 15th. Attending the signing ceremony were Daeryun Kim Kook-il, attorney Min-kyung Kwon, attorney Jo Woo-ri, Hyomin Medical Foundation Chairman Song Jeong-hoon, and hospital director Kim Ji-hyun. Hyomin Medical Foundation was established in 2010 and operates ‘Big Love Hospital’ and ‘Daegu Big Love Nursing Hospital’ located in Daehyeon-ro, Buk-gu, Daegu. Through this agreement, Daeryun plans to provide multi-layered legal services to the Hyomin Medical Foundation and its affiliated medical institutions, including ▲compliance advice to prevent violations of medical laws, ▲review of medical contracts and operating regulations, and ▲consulting to prevent legal disputes between medical professionals and patients. In addition, strategic legal support necessary for Hyomin Medical Foundation's ESG management and institutional certification response process is also provided. Hyomin Medical Foundation Chairman Song Jeong-hoon said, “This MOU will be a meaningful turning point that simultaneously improves patient safety and the sustainability of the institution.” Daeryun CEO Kim Kook-il said, “As many issues in the medical field are sensitive and complex, customized legal support is needed. Daeryun will go beyond simple legal advice and, as a legal partner of the Hyomin Medical Foundation, we will work together to design and implement legal solutions needed in the field.”[View full article] Tax and Finance News - Daeryun-Medical Corporation Hyomin Medical Foundation, Medical Law Compliance Business Agreement (Click here) International News - Daeryun Law Firm signs MOU with Hyomin Medical Foundation... Prevention of medical law violations and strengthening ESG legal advice (Click here)

[Busan Eastern Support] Rejecting claim of 'lack of responsibility' A (9), an elementary school student, threw a rock at his friend B at the playground of an elementary school in Haeundae-gu, Busan, causing wounds measuring 1 cm vertically below his left eye, 2 cm on his left cheek, and 1 cm below his nose. Accordingly, B and his parents filed a lawsuit against A and his parents, demanding compensation for damages. The superintendent of Busan Metropolitan City Haeundae Office of Education issued a written apology to A to the victim student following the resolution of the Busan City Haeundae Office of Education School Violence Measures Review Committee that A's actions constituted school violence. Judge Kim Joo-young of the Eastern Branch of the Busan District Court ruled on April 9 that both A and his parents were responsible for damages and that "the defendants should join together and pay 22 million won to the plaintiffs" (2024 Gadan 103511). The defendants argued to the effect that “A was only 9 years old at the time of the incident and therefore has no capacity for responsibility.” However, Judge Kim did not accept it, saying, "Capacity for responsibility generally refers to the mental ability to take responsibility for one's actions. In this case, the student who witnessed the assault stated, 'A was crying after the assault, saying he felt like he was going to get into school violence,' so it is difficult to say that A did not have the ability to take responsibility." Judge Kim also spoke about A’s parents. “Even if a minor has the capacity for responsibility and takes responsibility for a tort on his own, if the damage is causally related to the violation of the duty of the person responsible for supervising the minor, the person responsible for supervision is liable for damages as a general tortfeasor (see Supreme Court Decision 93da60588, August 23, 1994, etc.)”, and “At the time of the price act, A was living with the defendants and receiving their protection and supervision, and the defendants “It will be said that they have a duty to educate and supervise A, a minor, by providing daily guidance and advice so that he does not commit harmful acts against others. However, the defendants neglected the above-mentioned duty of guidance and supervision, and it is judged that such negligence was a cause of the price act. Therefore, as general tortfeasors, the defendants are jointly responsible for compensating the damages suffered by the plaintiffs in accordance with Articles 750 and 760 of the Civil Act.” Daeryun Law Firm represented the plaintiffs, and Shinsung Law Firm represented the defendants. Legal Times Reporter Kim Deok-seong (dsconf@legaltimes.co.kr)[View full article] [Grandpa] “A 9-year-old elementary school student threw a stone at a friend and hurt him… Parents are also responsible for compensation” (Go to the link)

Daeryun Customs and International Trade Group of Law Firm announced on the 19th that it signed a business agreement with the Small and Medium Business International Customs and Trade Advisory Center Cooperative (hereinafter ICTC) at its Seoul headquarters branch office on the 13th. The signing ceremony was attended by Daeryun Kim Kuk-il, CEO of the Korea Customs and International Trade Group, Myeong Jae-ho, customs expert at the Customs and International Trade Group, ICTC Chairman Kim Seok-oh, Manager Kim Jin-young, and members Park Jeong-ho and Lee Jong-in. ICTC is a cooperative comprised of customs brokers, tax accountants, and businessmen, and is a specialized organization that supports small and medium-sized enterprises in entering the global market. Through representative offices operating in 15 overseas regions, including the United States, China, and Europe, we provide one-stop integrated advisory services ranging from export market research to trade, customs clearance, and marketing, and operate differentiated programs such as FDA registration and certification of export foods and tax tech services in response to U.S. reciprocal tariffs. Through this MOU, Daeryun plans to provide advice on ▲ foreign exchange transaction law and customs-related risk advice for import and export companies ▲ trade legal consulting such as FDA registration and HS code disputes ▲ construction of a system to respond to complex tax, accounting, and legal issues. Daeryun is about to open overseas offices in New York, USA and Tokyo, Japan, and provides practical advice to companies wishing to expand into the local market. ICTC Chairman Kim Seok-oh said, “We expect that by combining Daeryun’s capabilities and global standards with ICTC’s trade expertise, we will be able to provide more practical field-oriented services to companies.” Kim Kook-il, CEO of Daeryun Management, said, “I hope that the cooperation between the two organizations with excellent capabilities will make a practical contribution to the global expansion and strengthening of competitiveness of domestic small and medium-sized businesses.”[View full article] Tax and Finance News - Daeryun Customs and International Trade Group, International Customs and Trade Advisory Center and Global Expansion Business Agreement (Go here) Sejeong Ilbo - Daeryun Law Firm Customs and International Trade Group signed an MOU with the International Customs and Trade Advisory Center (Click here)

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)