In Korea, the Pharmaceutical Affairs Act (the “PAA”) regulates activities involving pharmaceuticals (including biologicals) such as manufacture, permit/license, sale, distribution, advertisement and post-sale matters, and defers to the subordinate laws (e.g., the Regulation on Safety of Pharmaceutical Products, Etc., the Decree on Facility Standards for Manufacturing Business and Importers of Drugs, and the Regulation on Manufacturing and Sales of Biological Products, etc.) for more detailed regulations thereon.

Medical devices including in vitro diagnostic (IVD) medical devices are regulated by the Medical Devices Act (the “MDA”) and the In Vitro Diagnostic Medical Devices Act – e.g., obtaining a business license for manufacture and import thereof and other regulatory permits for manufacturing and sales activities, provision of economic benefits with respect to medical devices (e.g., samples permitted), and labeling and advertising methods.

As for food and food supplements, the Food Sanitation Act (food in general), the Health Functional Foods Act (food supplements), the Special Act on Safety Management of Imported Food (imported food), and the Act on Labeling and Advertising of Food (labeling and advertising in general) govern relevant matters, such as business license, quality control, and labeling and advertising of food products.

Each of the above statutes delegates regulation of more specific matters to the respective Enforcement Decree (i.e., Presidential Decree) and the Enforcement Rules (which are promulgated by each competent government authority including the Ministry of Health and Welfare, the “MOHW”). Even more specific matters delegated by the Enforcement Decree and the Enforcement Rules are set forth in the relevant Public Notices and Directives (promulgated by each competent government authority including the Ministry of Food and Drug Safety, the “MFDS”). Further, although not legally binding, guidelines and case studies (e.g., Cases of Naming Products by the MFDS) are referred to as practical guidelines by regulatory agencies.

With respect to pharmaceuticals, the PAA and its Enforcement Decree provide the standards for clinical trials intended to develop pharmaceuticals and require compliance therewith. Anyone intending to manufacture/import pharmaceuticals, must obtain a business license for manufacturing/importing and also obtain approval or file a report for each drug from the MFDS. Such approval/report requires submission to the MFDS of relevant information/materials (although different by product type) including the development history, quality and safety, toxicity, pharmacological action, clinical test results, and status of use in foreign countries in accordance with the Regulation on Pharmaceuticals Approval, Notification, and Review. Pharmaceuticals are subject to reexamination by the MFDS within three months following the date falling four to six years from the date of prior product approval, based on the results of post-marketing surveillance (“PMS”).

The MDA provides for clinical trials, manufacturing/import business license, manufacturing/import permit, certification or report of each medical device, report on the sales or lease business, and PMS procedures, etc. with respect to medical devices. For example, anyone who intends to manufacture/import medical devices must prepare a protocol for clinical trials on medical devices and obtain approval thereof from the MFDS in order to conduct clinical trials. Also, they must have installed necessary facilities and manufacturing/quality control system and obtain a manufacturing license from the MFDS, and also apply for permit/certification or file a report for manufacture/import of each medical device by submitting materials (e.g., technical documents, clinical trial data) which list depends on the risk class of medical devices.

Anyone intending to manufacture food supplements must install manufacturing facility and employ a quality control officer, obtain a business license for manufacturing food supplements from the MFDS, and file a report with the MFDS for each item to be manufactured.

Sale of food supplements requires registration of the import/sale business and also any overseas manufacturing facility (local due diligence can be conducted) with the MFDS, and then reporting on each item of imported food supplements, pursuant to the Special Act on Imported Food Safety Control (the “Imported Food Act”).

Food supplements must be manufactured using ingredients recognized by the MFDS as functional ingredients and must meet the standards and specifications of the Health Functional Food Code.

In addition, manufacturers and distributors of food supplements, drug store owners under the PAA, and importers and sellers of imported foods under the Imported Food Act must report to the MFDS on any adverse effect of food supplements (any undesirable or unintended sign, symptom or disease suspected to have been caused by food supplements).

Manufacturers/importers of pharmaceuticals are subject to reexamination after a certain period (e.g., six years for a new drug), must submit documents required for renewal of pharmaceutical approval or report before the expiry date, must perform the risk management plan submitted at the time of obtaining the existing pharmaceutical approval and report side effects and other safety related information. For reference, if the use of the pharmaceuticals results in, or is likely to result in, harm to the public health, there may arise an obligation to recall or dispose of such products on the market.

Manufacturers/importers of medical devices must designate a quality control manager to guide and supervise employees engaged in manufacture and import of medical devices, and to oversee manufacture/import, quality, and safety matters.

Manufacturers/importers of newly developed medical devices or orphan medical devices must, if requested by the MFDS, conduct a PMS on the safety and effectiveness thereof.

The MFDS has the regulatory oversight over pharmaceuticals, including the manufacture, import and sale thereof, and other relevant issues such as clinical trials, permits, advertisements, and post-sale safety matters, while the MOHW oversees distribution of pharmaceuticals, including establishment of sales order, reports on supply details, and listing with the health insurance and pricing of pharmaceuticals.

To elaborate, the MFDS regulates obtaining a business license for manufacturing/import business, other permits required for engaging in the manufacture/import, sale, lease and repair business, the PMS, and advertisements of medical devices. The MOHW regulates matters relating to medical devices, such as rebates and reporting on provision of economic benefits, and the MFDS and the Korea Fair Trade Commission (the “KFTC”) are responsible for regulating labeling and advertisement of medical devices.

Overall regulation of foods and food supplements is administered by the MFDS which directly regulates manufacture and import and oversees sale through the competent local government by delegation. Customs clearance is regulated by the Korea Customs Service but to the extent of perfunctory review of whether the submitted customs documents, as prescribed by the MFDS, are in order. The MFDS monitors overall quality, labeling, and advertisement of food and food supplements and administratively sanctions violations thereof. The KFTC may intervene in unfair competition activities, including unfair labeling and advertisement.

Where the MFDS imposes administrative sanctions such as suspension of sale, corrective order, imposition of fine, or revocation of permit with respect to pharmaceuticals, medical devices, foods and food supplements, the sanctioned person may (i) file an objection (in response to an Advance Notice) in accordance with the Administrative Procedure Act before such administrative sanction is imposed, and (ii) after the administrative sanction is rendered, file an administrative appeal with the court or the Administrative Appeals Committee to argue revocation or invalidation of the administrative sanction.

The MFDS and the competent local government may order revocation of permit, certification, approval or report, office closure, prohibition of manufacture, import or sale of a product class or product, or suspension of all or part of the business for up to one year. Moreover, they have the authority to order suspension of use, impose fines and/or issue corrective orders and public announcement of violation.

To elaborate, prior to the official imposition of the administrative sanction, the sanctioned person may submit an opinion upon receipt of the Advance Notice on the administrative sanction to be imposed. After the administrative sanction is rendered, the sanctioned person may claim revocation or invalidation of the administrative sanction by filing an administrative appeal with the Administrative Appeals Commission or an administrative claim with the court.

Clinical trials for pharmaceuticals are regulated by the PAA and the Regulation on Safety of Pharmaceutical Products, Etc. In order to conduct clinical trials, pharmaceutical companies must submit a clinical trial protocol to the MFDS for approval and conduct clinical trials at a designated clinical trial institution. Further, clinical trials must be conducted in compliance with the Regulation on Safety of Pharmaceutical Products, Etc. Such standards govern (i) the implementation of clinical standards (e.g., selection of the principal investigator (PI) overseeing the clinical trial, establishment of safety measures, implementation of clinical trials within two years after approval of the protocol) and (ii) the management of clinical trials (e.g., establishment of the institutional review board (“IRB”), obtaining consent from the subjects).

Anyone intending to conduct a medical device clinical trial pursuant to the MDA must submit to the MFDS a clinical trial protocol, the GMP data for the medical device, technical documentation data, etc. as stipulated in Article 20 of the Enforcement Rules of the MDA, and obtain approval thereof from the MFDS. After the IRB approval of the institution conducting the clinical trial, the following reports must be submitted: (i) a report on abnormal reactions, (ii) a status report on the clinical trial by the last date of February every year, and (iii) the completion report after completion of the clinical trial, together with a report on the clinical trial results.

Information related to the MFDS approval of clinical trials (e.g., date of approval, name of the product, title of the clinical trial, name of the implementing institution) is disclosed on the websites operated by the MFDS:

In accordance with the comprehensive disclosure system of important pharmaceutical and bio information (the “Comprehensive Disclosure System”), and for the protection of investors in listed companies, information on the status of clinical trials (e.g., submission of the investigational new drug (IND) application, and change, suspension or termination of important contents thereof, clinical trial results, general information on the clinical trials including the disease(s) which the clinical trials are intended to ultimately help treat or prevent, implementation method, expected effects) is disclosed on the websites of the Financial Supervisory Service and the Korea Exchange

There is no particular restriction on utilization of clinical trial data that are disclosed by the MFDS with respect to the clinical trial approval and those disclosed per the Comprehensive Disclosure System, but the disclosure is limited unlike other jurisdictions and thus the use of the clinical trial data is also limited (i.e., only to the extent of disclosed data).

After COVID-19, digitalization of clinical trials, i.e., decentralized clinical trials (“DCTs”) became an issue of heated discussions. It has been pointed out that there is some practical limitation to implementing DCTs due to the current laws prohibiting remote medical treatment and delivery of medicine. However, the Korean government has begun improving the clinical trial system by preparing measures to build and support DCTs and pursuing projects developing core technology and guidelines for the activation of DCTs.

The most significant legislative milestone is the Act on Digital Medical Products (the “DMPA”), which officially went into effect on January 24, 2025. This legislation provides a dedicated legal framework for digital medical devices and software, streamlining their clinical trial and approval processes separately from traditional medical devices. Notably, the DMPA establishes a legal basis to facilitate the overall digitalization of clinical trials by allowing the use of digital tools for remote monitoring and data collection, which are essential components of DCTs.

In order to prepare for implementation of DCTs, the MFDS amended the Guidelines on Electronic Consent to Clinical Trials to strengthen protection of rights and benefits of subjects who are not familiar with digital technology for when obtaining their consent to participation in clinical trials by electronic means.

In addition, a public-private expert council has been operated from January 2024 to further develop and improve the system for obtaining “electronic consent to clinical trials” that is necessary for implementing DCTs.

These efforts culminated in the introduction of the comprehensive Guidelines on Collecting Clinical Trial Data Using Digital Technology by the MFDS, which established the technical and security standards for collecting clinical trial data via wearable devices and mobile apps, addressing long-standing concerns regarding data reliability in decentralized settings.

With respect to software medical devices, clinical studies on human subjects may be replaced by data-based studies. For example, for clinical trial data, retrospective studies that apply past diagnostic data and real-world evidence (RWE) generated from use of medical devices may be submitted when applying for the product approval.

This RWE-based approach has been further institutionalized under the DMPA, which specifically allows for real-world evaluation to be utilized in the initial approval and subsequent amendment approval processes of digital medical products.

In order to manufacture pharmaceuticals or medical devices, the manufacturer must obtain approval from the MFDS after installing manufacturing and quality control facilities and devices, quality control test room, and storage room for raw materials and other materials, etc. in accordance with the facilities standards applicable to manufacturers/importers of pharmaceuticals, etc. and as applicable, the Enforcement Rules of the MDA. In addition, the manufacturer must carry out manufacturing activities in accordance with the GMP by e.g., employing and training a manufacturing manager or a quality control officer.

The manufacturing facilities for food supplements must be kept away from any pollutant generating facilities, and each component facility must be managed in a sanitary manner. The manufacturing facilities must have an independent workplace (so that no other products are also produced at the same place), warehouse, storage facility (which can be used jointly with other pharmaceuticals, etc.), and quality control room (which may be omitted if outsourced), etc.

Similar facility requirements apply to overseas manufacturing facilities for food supplements that are imported, and on-site due diligence is performed to ensure compliance with the Imported Food Act.

Manufacturers of food supplements can obtain GMP certification from the MFDS after setting up SOPs for quality control purposes, in addition to the above facility requirements. The GMP mark may only be attached to food supplements only if the manufacturer has obtained the GMP certification from the MFDS.

Generally, pharmaceuticals manufactured or imported by pharmaceutical companies are supplied to drug wholesalers, which in turn sell the pharmaceuticals to hospitals and pharmacies (approximately 90%), but in some cases, pharmaceutical companies directly supply pharmaceuticals to hospitals and pharmacies (approximately 10%). On the other hand, only hospitals and pharmacies may sell pharmaceuticals to end consumers with no more than twenty over-the-counter drugs (e.g., fever reducers, digestives) which may be sold by 24/7 convenience stores from 2013.

Medical devices are generally sold to medical institutions or consumers (i) directly by the manufacturer/importer or (ii) by sellers/lessors, persons establishing medical institutions or persons engaged by said persons to sell or lease the medical devices.

Engaging in the business of manufacturing food supplements requires a business license from the MFDS, and the import/sale of imported food requires business registration with the MFDS. However, sales only requires notification to the local government, which is relatively simple. Therefore, food supplements are distributed through the general online and offline FMCG distribution channels, as well as via pharmacies.

The Korean Health Insurance System adopts a method in which the National Health Insurance Service (the “NHIS”) reimburses medical providers (medical institutions, pharmacies) that provide medical services to health insurance subscribers (citizens).

• The drugs and medical supplies approved by the MFDS for sale are selectively registered with the Positive List System, if they have excellent therapeutic value (medical validity) and economic value (cost efficiency and possibility of replacement), in accordance with the National Health Insurance Act and are priced as determined at the time of the registration.
• Pharmaceuticals and medical supplies that are covered by health insurance mean that patients may use them with prescription at the applicable health insurance price. In practice, such pharmaceuticals and ingredients are supplied to wholesalers, medical institutions, etc. at the price set at the time of registration plus distribution margin.

The reimbursement procedures for medical devices differ depending on whether the medical device becomes part of medical practice as medical equipment or is a therapeutic ingredient.

Medical equipment used as part of medical practice must be reimbursed as part of medical practice in accordance with the Public Notice on the List of Reimbursable Treatments and Non-reimbursable Treatments and Reimbursement Relative Value Scale. The application for reimbursement with respect to medical treatment is only available to medical-care institutions or medicine-related organizations.

Medical supplies mean medical devices that are consumable products other than medical equipment. The manufacturer/importer may apply for a decision on whether the medical supplies are eligible for reimbursement. For new medical technology, the relevant evaluation results should be examined, and if the distinction is unclear, it should be confirmed whether the relevant acts are eligible for reimbursement.

If the relevant acts (existing technology) clearly exist, the MOHW must evaluate, via the specialized evaluation committee of medical supplies, the economic feasibility and the adequacy of benefits and determine whether such acts are eligible for reimbursement. If the medical treatment or medical supply is found eligible for reimbursement, the upper limit of reimbursement must be calculated by checking whether products with identical purpose are registered and comparing with the cost, effect, function, etc. of the registered products.

There have been no cases where national health insurance reimbursement was provided to food or food supplements.

The PAA prohibits false or exaggerated advertisements about the name, manufacturing method, efficacy or performance of pharmaceuticals, advertisements where doctors guarantee/recommend the performance, efficacy or effect of pharmaceuticals, advertisements slandering other products, and those using consumer experiences or promoting prescription drugs, but permits limited advertisement of preventive drugs or advertisements targeting medical/pharmaceutical experts. Advertisements of pharmaceuticals in such media as newspapers, magazines, broadcasting, radio, the Internet, online newspapers, etc. that are set forth in the PAA are required to pass review by the MFDS (or a review body delegated by the MFDS for review of advertisements, i.e., the Drug Advertisement Review Committee of the Korea Pharmaceutical and Bio-Pharma Association).

As for medical devices, the MDA similarly prohibits false or exaggerated advertisements, advertisements with doctors guaranteeing/recommending the performance, efficacy and effect of medical devices, and those using consumer experiences. Advertisements via such media as provided by the MDA are required to be reviewed by an institution or organization reported to the MFDS (i.e., the Medical Device Advertisement Review Committee of the Korea Medical Devices Industry Association and the Autonomous Advertisement Review of the Korea Medical Devices Association).

Labeling and advertisement of food and food supplements are regulated by the MFDS in accordance with the Act on Labeling and Advertising of Food. Food and food supplements must be labeled with statutory indications (e.g., the manufacturing date), and false or exaggerated advertisements (e.g., advertisements that are likely to describe the food or food supplements as having efficacy in the prevention and treatment of diseases) are prohibited. Unfair advertising activities such as slandering competing products are also restricted. In general, food advertisements do not need to undergo a preliminary review process, but advertisements of food supplements are required to pass Autonomous Advertisement Review of the Korea Advertising Review Board in advance.

The Patent Act and the Trademark Act govern patents and trademarks of pharmaceuticals, medical devices, and food supplements.

In order to obtain a patent, the subject product must be available for industrial use (industrial availability), must not be already known before filing the patent application (novelty), must not be easily conceived from prior technology (advancement). For trademarks, they must be distinctive and should not infringe benefits to the public or to other persons.

There are three possible options to defend against patent infringement: (i) file legal proceedings (e.g., claim invalidation, request confirmation of scope of negative rights, claim confirmation of absence of infringement claim), (ii) present a defense in litigation by arguing (a) exclusion of publicly known technology, (b) abuse of rights (exercise of rights based on invalid patent rights), (c) statute of limitations (three or ten years), and (d) free technology, or (iii) settle the case and avoid litigation.

Patent infringement lawsuits for drug or medical device are generally initiated by the patent holder claiming infringement and filing a lawsuit if they determine that their patent rights have been infringed. In litigation, the court examines the validity and infringement of a patent, reviews the relevant evidence submitted and hears arguments from both sides. The court decision would determine whether there has been patent infringement, and the parties would subsequently take legal measures in accordance therewith (e.g., seeking compensation for damages, prohibition of further infringement).

Trademarks registered with the KIPO are protected by the Trademark Act, and unregistered trademarks, trade names, and other business marks are protected by the Unfair Competition Prevention Act. Therefore, if trademark rights are infringed, legal remedies can be sought through provisional injunction against infringement in a civil proceeding.

For pharmaceuticals, medical devices, foods, and food supplements under the jurisdiction of MFDS, the use of trademarks may be indirectly restricted to prevent consumer misperception (e.g., pharmaceutical trademarks on food may lead to misunderstanding of food as pharmaceuticals), but the restriction on direct use of trademarks is limited from the perspective of IP rights protection or prevention of unfair competition.

Exceptionally, for pharmaceuticals, a brand name that has a letter or number added to or replacing that in the name of a product that has already been approved may be used if the relevant product has similar efficacy and effect as the approved product. Further, if a foreign trademark is used in the application stage for product approval without attaching any supporting documents of the trademark holder, the application may be denied.

Pharmaceutical companies are obligated to report side effects of pharmaceuticals, and such drugs may be subject to recall. If a side effect occurs, the MFDS may remedy the victim and the cost of such remediation would be paid from the charges collected from the pharmaceutical companies.

If clinical trials are conducted for the development of pharmaceuticals, insurance must be obtained to indemnify or compensate the subjects for any damage to their health. In compensating the subjects, the procedures explained to the subjects in advance must be complied with.

Under the MDA, manufacturers/importers of medical devices that are inserted into the human body and maintained continuously for at least 30 days must purchase insurance or mutual aid to compensate for damage to affected patients.

If there is a material defect in quality control or performance of a medical device manufactured/imported after obtaining a permit or certification or filing a report, or if it has caused or is likely to cause harm to public health, or if it has no efficacy, the MFDS may revoke the permission, certification or notification.

The Food Sanitation Act or the Health Functional Foods Act do not separately stipulate the liability of a business operator to compensate consumers, and thus the business operator is held responsible for such liability in accordance with the general consumer dispute resolution process. In the pre-litigation stage, unless the parties express their intention regarding how to resolve the dispute, the consumer dispute resolution standards announced by the KFTC would be the basis for settlement or recommendation. If the parties fail to settle, the dispute would proceed as civil litigation for damages, and the causal relationship between the business operator’s intention or negligence and the damage would be an element in establishing liability.

The Product Liability Act recognizes the liability for damages to the life, body, or property of a consumer caused by a product defect (defect in the manufacture, design or labeling), regardless of whether the manufacturer (including the actual manufacturer and the person who uses the name, trademark, etc. to be misunderstood as the manufacturer) is at fault or not. If the manufacturer is aware of the defect but fails to take necessary measures and causes serious damage to life or body, the manufacturer would be liable for punitive damages up to three (3) times the amount of such damage.

Under the PAA/MDA, pharmaceutical/medical device companies must (i) comply with the manufacturing and quality control standards when manufacturing and importing pharmaceuticals/medical devices, and perform post-marketing safety management even after product approval is obtained. Violation may result in criminal liability (imprisonment or fine) for the individual offender, and the employer of the offender may be fined. Further, the MFDS may ban the manufacture/import of the relevant product or suspend all or part of business up to one year. (ii) Pharmaceutical companies are prohibited from illegally providing economic benefits to medical practitioners, medical institutions and pharmacies. Violation may result in criminal liability to the individual actor, and the employer fined. Further, the MFDS may suspend sale of the relevant product. (iii) If a person fails to register a manufacturing/import business or obtain a manufacture/import license, certification or report, or does so by fraud or other improper means, he/she may be imprisoned or fined, and the employer

For violation relating to food products, potential penalties are as follows. Also, the MFDS or the authorized local government may render an administrative decision such as revocation of business license, registration and report, suspension of business, or recall and disposal of products.

The Act on Digital Medical Products (the “DMPA”) officially took effect on January 24, 2025, establishing a specialized regulatory framework distinct from the traditional Medical Devices Act (the “MDA”). The new DMPA relatively streamlines regulatory filing and GMP requirements for digital medical products, acknowledging that software-based devices differ significantly from hardware-based medical devices in terms of manufacturing processes and rapid update cycles.

Under the DMPA, digital health applications are categorized into “digital medical devices”– which are subject to both the DMPA and the MDA – and “digital medical/health support products” to which the MDA does not apply. The distinction between the two is primarily based on their intended use, but it can be ambiguous in practice. To address such complexities, the MFDS operates a public service center to help determine whether a digital health application is a medical device or not. If a digital health application is classified as a software medical device, it can be created and sold only after obtaining product approval from the MFDS in accordance with the MDA.

Regarding market access, the NHIS has expanded its reimbursement framework to include a broader range of digital health technologies. Beyond initial cases like digital therapeutics for insomnia and AI-based image analysis, coverage now extends to software for visual field training, respiratory rehabilitation, and AI diagnostic tools for emergency triage. These technologies are typically granted provisional listing – often as selective reimbursement with a high patient co-payment rate (e.g., 80% to 90%) – to gather the real-world clinical evidence required for final formal reimbursement decisions.

Digital health applications must be operated in compliance with personal information protection laws (e.g., restrictions on transfer of electronic medical records under the MDA and restrictions on overseas transfer under the Personal Information Protection Act, the “PIPA”), and the data flow and consent structure to ensure compliance must be consistent with the PIPA and the guidelines of the Personal Information Protection Commission (the “PIPC”).

Additionally, the Framework Act on the Development of Artificial Intelligence and Establishment of Trust (the “AI Basic Act”) took effect on January 22, 2026. This Act designates medical devices incorporating AI systems as “high-impact AI,” imposing obligations such as risk management and transparency. However, as the Ministry of Science and ICT has deferred the enforcement of administrative fines for at least one year and medical-specific guidelines are still pending, the practical regulatory impact remains to be seen.

A bill to amend the PAA is pending at the National Assembly. It is primarily intended to designate drugs with unstable supply and demand, order production of such drugs making available compensation for losses from such production, and newly establish a committee to systematically address the unstable supply and demand.

In order to prevent unfair customer solicitation pursuant to the Monopoly Regulation and Fair Trade Act, pharmaceutical companies and medical device companies are invited to form a business association and establish fair competition rules, thereby maintaining fair competition.

Such fair competition rules prohibit pharmaceutical/medical device companies providing economic benefits to medical practitioners, etc., while permitting certain acts, e.g., (i) donation, (ii) support for hosting, operating and participating in academic conferences, (iii) product presentations, (iv) provision of clinical trial drugs, (v) market research and PMS, and (vi) exhibitions, advertisements, lectures and advisory services.

Legislative Formalization of Telemedicine: Telemedicine, which was temporarily permitted under discretionary measures during the COVID-19 pandemic, has recently been permanently formalized through legislation. This transition follows a period of heightened regulatory scrutiny regarding the potential misuse of prescriptions for lifestyle drugs, such as those for hair loss, erectile dysfunction, and obesity. While the new legal framework establishes a permanent basis for remote care, it maintains strict safeguards: in-person consultation remains the mandatory principle for initial visits, and certain categories, including obesity treatments, are strictly excluded from the scope of telemedicine prescriptions to mitigate public health risks.

Enforcement of the Digital Medical Products Act: For recent legislative efforts, the Digital Medical Products Act – which is applicable also to digital medical devices – took effect as of January 24, 2025. In connection therewith, the Digital Medical Products Act stipulates that “medical devices using digital technology” are considered “digital medical devices” (Article 2, Subparagraphs 1 and 2). Since “digital medical devices” will be subject to regulations specific to digital medical devices, such as licensing review standards, manufacturing and quality control standards, clinical trial plan approval and management standards, electronic infringement security guidelines, and good management system certification standards, it is important to determine which products previously regulated under the Medical Devices Act and the Act on In Vitro Diagnostic Medical Devices will now fall within the scope of the Digital Medical Products Act.

Enforcement of the Act on the Promotion of the Food Tech Industry: In a significant move to foster high-value-added future industries, the Act on the Promotion of the Food Tech Industry officially entered into force on December 21, 2025. This legislation establishes a comprehensive legal framework for the Food Tech sector, which integrates advanced technologies such as AI, robotics, and biotechnology with the food industry. Under this Act, the Ministry of Agriculture, Food and Rural Affairs (MAFRA) is mandated to establish a comprehensive promotion plan every five years and is authorized to designate food tech innovation clusters. The law also provides the legal basis for specialized administrative and financial support, marking a pivotal transition toward a technology-driven food ecosystem in Korea.

Cosmetics Safety Evaluation System: The MFDS has finalized a pivotal regulatory roadmap to implement the cosmetics safety evaluation system. Following the 2025 legislative groundwork, the cosmetics safety evaluation system has officially been introduced under the amended Cosmetics Act. Pursuant to the amendments, responsible cosmetic sellers are now required to prepare and retain cosmetics safety evaluation data for each product prior to distribution to verify its safety profile. These documents must undergo a formal review by a qualified professional meeting specific academic or career criteria as prescribed by law. Furthermore, the regulatory authority now holds the power to demand the submission of such data for public health concerns, and sellers are obligated to comply unless there is a justifiable reason for non-disclosure. To mitigate industrial impact, this system is being introduced incrementally based on annual production volume and product launch status: (i) for sellers with annual production or import volumes of KRW 1 billion or more, or for newly registered sellers, (a) January 1, 2028, with respect to products newly subject to functional cosmetics review or report; (b) January 1, 2030, with respect to products newly manufactured or imported and launched; and (c) January 1, 2031, for all other cases not falling under (a) or (b); and (ii) for sellers with annual production or import volumes of less than KRW 1 billion: January 1, 2031.

*Supreme Court’s Definition on the Scope of Patent Infringement for Exporting Drug Intermediates: In 2025, the Supreme Court of Korea rendered a landmark decision clarifying the boundaries of patent infringement in the context of global supply chains. The Court ruled that the domestic manufacture and export of vaccine drug substances (bulk intermediates) do not constitute “direct infringement”. The rationale was that the conjugate bulk produced within Korea cannot be regarded as a completed vaccine, and the technical effects of the patented invention were not fully realized through domestic manufacturing alone. The Court emphasized that the completion of the vaccine requires a complex formulation process involving precise variables such as input volume, mixing ratios, pH, and temperature. The Court also dismissed the “indirect infringement” claim by strictly applying the “Principle of Territoriality”. It held that “production” under the Patent Act must occur within the territory of Korea and therefore, if the final patented product is assembled abroad, the domestic supply of its components cannot establish indirect infringement, even if the preceding manufacturing steps took place within Korea. This ruling provides a vital legal shield for Korean biotech companies, clarifying that the “Principle of Territoriality” protects the export of raw materials and semi-finished products from domestic patent infringement claims.

The recent trend is to enhance interoperability of electronic medical records. (i) The MOHW grants additional points for reimbursement to medical institutions that use EMR software certified as electronic medical record system. (ii) The MOHW is working on data standardization after announcing the Korea Core Data for Interoperability, and is also discussing ways to link the patient-generated health data (PGHD) thereto. (iii) Discussions on the “My Health-way” policy are underway to allow the NHIS to transmit information of the insured (i.e., every Korean citizen due to the mandatory health insurance system) at the request of the relevant insured.

Regulatory Impact of the AI Basic Act on Medical Devices: Regarding AI, the Framework Act on the Development of Artificial Intelligence (the “AI Basic Act”), which took effect in January 2026, designates medical devices incorporating AI as “high-impact AI.” This designation imposes broad obligations concerning risk management and transparency. However, as the Ministry of Science and ICT has deferred the enforcement of administrative fines for at least one year and medical-device-specific guidelines are not yet published, the full regulatory impact remains to be seen. In the interim, the MFDS’s existing product approval and clinical review standards serve as the primary practical benchmark for regulatory compliance.

Further, the MFDS is increasingly integrating artificial intelligence (AI) into regulatory oversight and approval processes. The MFDS is introducing AI-based risk prediction systems to identify high-risk imported foods and to proactively manage major food hazards. At the same time, the MFDS is strengthening regulation of digital advertising by explicitly prohibiting AI-generated advertisements featuring fake doctors or pharmacists and enhancing real-time monitoring of illegal online distribution of drugs through AI-based surveillance systems. In addition, to shorten the approval and review period to 240 days, which would be considered among the shortest globally, the MFDS is introducing digital tools, including an AI-based approval and review support system, to assist reviewers with document summaries, translations, and draft review reports.

Legislation on Alternatives to Animal Testing and Development of Test Methods

The current Animal Protection Act stipulates that alternatives must be considered first before animal testing, and the Laboratory Animal Act requires the Minister of the MFDS to establish and promote policies for the development of alternatives to animal testing. Further, the Cosmetics Act prohibits, in principle, the distribution and sale of cosmetics manufactured through animal testing if alternatives to the animal testing exist. However, although laws supporting alternatives to animal testing are also being developed in Korea, there is currently no legal basis for them. On July 25, 2024, the “Bill on Promotion of the Development, Dissemination, and Use of Alternatives to Animal Testing” was proposed and is currently pending before the Health and Welfare Committee of the National Assembly. During the parliamentary audit in October 2024, the MFDS stated that it would make active efforts to ensure that such bill on alternatives to animal testing is enacted in accordance with the intent of the law.

From 2025 to 2029, the MFDS plans to invest KRW 11.64 billion to carry out the project for “the establishment of a foundation for alternative evaluation technologies using animals for vaccine quality control.” The project aims to develop test methods that can replace laboratory animals used for quality control required for approval of release of botulinum and DTaP (diphtheria, tetanus, pertussis) vaccines. Starting next year, the MFDS plans to conduct verification of related methods, such as a test method that implements the in vivo botulinum toxin mechanism in a test tube, a detoxification test method, and a potency test method, until 2026. From 2027, it plans to lead the regulation of alternatives to animal testing by reflecting them in the World Health Organization (WHO) vaccine-related technical documents through international joint research with foreign institutions, such as those in Europe. The MFDS plans to create an environment for practical technological independence through self-production and supply of reaction reagents (antibodies, etc.) used in testing methods in 2028, and to delete the existing animal testing methods and integrate alternatives to animal testing in the “Notice on Biological Product Standards and Testing Methods” to be issued in 2029.

Proposal of the AI Bio-Health Industry Promotion and Support Act: In December 2025, a bi-partisan bill titled the Act on the Promotion and Support of the AI Bio-Health Industry was proposed. This legislation represents a strategic pivot in the national healthcare paradigm from reactive treatment to proactive prevention and personalized management utilizing AI technologies. This proposed Act would mandate the establishment of a comprehensive promotion plan every five years and the creation of an AI bio-health industry committee to serve as a national control tower. This proposed Act is expected to provide a robust legal foundation for integrating AI into the broader bio-health ecosystem, fostering global competitiveness and private investment in the life sciences sector.

Expansion of Collaborations for Precision Medicine and Healthcare: A notable trend in South Korea is the increasing collaboration between pharmaceutical companies and medical device, In-Vitro Diagnostics (“IVD”), or genetic sequencing companies, signalling the early stages of a transition toward precision healthcare.

• These partnerships are expanding into areas such as daily blood pressure monitoring, emergency room triage systems, and employee-benefit premium health checkups. It is noteworthy that these emerging preventative and diagnostic products are penetrating the healthcare industry by leveraging the robust sales networks of pre-existing business entities, such as those established by large Korean pharmaceutical companies.
• While the MFDS has provided formal guidelines for the product approval of certain collaborative models – such as traditional companion diagnostics (CDx) for oncology – and the MOHW has ruled that the marketing of genetic testing by insurance agents is illegal, there remain various emerging business models on which regulators have yet to provide a formal opinion. The industry continues to observe how regulatory frameworks will evolve as these models for personalized patient management further diversify.