📋 Korean Law Insight | Healthcare & Medical Law
By Attorney NOH UJIN | HANBYOL LAW LLC, Seoul
Medical Malpractice and Healthcare Law in Korea: A Complete Guide for Foreign Patients and Investors
South Korea has emerged as one of Asia's premier medical tourism destinations, attracting hundreds of thousands of foreign patients each year for procedures ranging from cosmetic surgery to complex oncology treatments. With this surge in medical activity comes a corresponding rise in disputes — and foreign patients, hospital investors, and pharmaceutical companies must understand the Korean legal framework governing medical malpractice and healthcare regulation.
This guide provides a comprehensive overview of Korea's healthcare law landscape, including how malpractice claims are filed, what compensation patients can seek, how criminal liability attaches to healthcare providers, and what regulatory frameworks govern foreign participation in the Korean medical sector.
1. Legal Framework: Key Statutes Governing Healthcare in Korea
Korean healthcare is governed by an interlocking set of statutes. The primary legislation includes:
- Medical Service Act (의료법) — Governs licensing, hospital operation, and physician obligations. It defines "medical acts" and establishes the legal duties of doctors, dentists, and other healthcare providers.
- Medical Malpractice Damage Relief and Medical Dispute Mediation Act (의료사고 피해구제 및 의료분쟁 조정 등에 관한 법률, 2012) — Establishes the Korea Medical Dispute Mediation and Arbitration Agency (KODIMA) as a specialized ADR body for medical disputes.
- Pharmaceutical Affairs Act (약사법) — Regulates drug approval, marketing, and pharmaceutical liability.
- Act on the Bioethics and Safety (생명윤리 및 안전에 관한 법률) — Governs bioethics, clinical trials, and human subject research.
- National Health Insurance Act (국민건강보험법) — Provides the framework for Korea's universal health insurance system.
Civil liability for medical malpractice is grounded in the Civil Act (민법), specifically Articles 390 (breach of contract) and 750 (tort). Criminal prosecution may follow under the Criminal Act (형법) for gross negligence resulting in death or injury.
2. Standards of Care and Proving Medical Negligence
Korean courts apply an objective standard of care based on what a reasonably competent physician in the same specialty would have done under similar circumstances. This standard is informed by clinical guidelines, peer-reviewed medical literature, and expert testimony.
To prevail in a medical malpractice claim, a plaintiff must establish:
- Duty of care — A doctor-patient relationship existed.
- Breach — The provider deviated from the accepted standard of care.
- Causation — The breach caused the plaintiff's harm.
- Damages — Quantifiable harm resulted (physical, psychological, financial).
Korean courts have significantly relaxed the causation requirement for plaintiffs. Under the doctrine of res ipsa loquitur as adapted in Korean jurisprudence, courts may infer negligence when an injury is of a type that would not ordinarily occur without fault, and when the circumstances surrounding the injury were within the provider's exclusive control. The Supreme Court of Korea has held that once a patient establishes that an injury occurred during a medical procedure, the burden of proof shifts to the healthcare provider to demonstrate the absence of negligence (Supreme Court Decision 2004다13288, May 2004).
3. Compensation: What Damages Are Available?
Korean courts award both pecuniary and non-pecuniary damages in medical malpractice cases:
| Damage Type | Description | Typical Range |
|---|
| Lost Income | Future earning capacity reduced by disability or death | Calculated on actuarial basis |
| Medical Expenses | Past and future treatment costs | Actual costs proven |
| Solatium (위자료) | Non-pecuniary emotional distress damages | KRW 20M–150M per case |
| Funeral Expenses | In wrongful death cases | KRW 5M–10M standard |
| Caregiver Costs | Home nursing and assistance expenses | Varies by duration |
Solatium (위자료) is the most debated element. Korean courts have historically awarded relatively modest amounts compared to Western jurisdictions, but amounts have been increasing. In serious cases involving permanent disability or death of the primary wage earner, total damages including solatium can exceed KRW 500 million (approximately USD 380,000).
4. The KODIMA Mediation Process
The Korea Medical Dispute Mediation and Arbitration Agency (KODIMA / 한국의료분쟁조정중재원) was established in 2012 to provide an alternative to full litigation for medical disputes. Key features:
- Filing: Either the patient or the healthcare provider may initiate mediation. Since 2016, automatic commencement applies in cases involving death or serious disability — meaning mediation begins without the hospital's consent.
- Timeline: KODIMA aims to complete mediation within 90 days of acceptance.
- Costs: Filing fees are nominal (KRW 10,000–50,000). Expert examination is free of charge.
- Outcome: A KODIMA mediation settlement has the same legal effect as a court judgment. If parties reject mediation, arbitration is available as an alternative.
- Damage Compensation Fund: KODIMA operates a special fund to compensate victims in cases where the liable provider is insolvent or uninsured.
For foreign patients unfamiliar with Korean courts, KODIMA offers a significantly more accessible and faster route to compensation. English-language assistance is available at the Seoul office.
5. Criminal Liability for Medical Negligence
In Korea, medical professionals may face criminal charges for gross negligence resulting in patient death or serious injury. The primary statutory basis is:
- Criminal Act Article 268 — "Professional negligence causing death or injury" — punishable by up to 5 years imprisonment or a fine of up to KRW 20 million.
- Medical Service Act Article 87 — Criminal penalties for practicing medicine without a license or performing prohibited procedures.
Criminal prosecution for medical negligence is relatively rare in Korea and typically reserved for egregious cases such as operating on the wrong body part, leaving surgical instruments inside patients, or administering lethal medication doses. However, the threat of criminal complaint is frequently used as leverage in civil settlement negotiations.
6. Informed Consent Requirements
Korean law imposes strict informed consent obligations. Under the Medical Service Act, physicians must explain to patients in a manner the patient can understand: the diagnosis, the proposed treatment or surgery, its risks and alternatives, and expected outcomes. Failure to obtain proper informed consent — even if the procedure itself is performed without negligence — can give rise to independent liability for the undisclosed risks that materialize.
The Supreme Court has held that the duty to inform encompasses rare but serious complications when the treatment is elective (Supreme Court Decision 2010da57787). For foreign patients, hospitals should document informed consent in the patient's language or ensure a qualified interpreter is present.
7. Foreign Patient Rights and Medical Tourism
Korea's Ministry of Health and Welfare has established a legal framework specifically addressing foreign medical tourists:
- Hospitals registered with the Korea Tourism Organization (KTO) as medical tourism facilitators must carry mandatory malpractice insurance.
- Foreign patients have the right to receive medical records (진료기록부) upon request — critical for pursuing claims in their home country as well as in Korea.
- The Medical Overseas Patient Support Center (해외환자지원센터) provides free legal and administrative support to foreign patients in disputes.
- Korea has specific visa categories (Medical C-3-3, Medical Treatment D-9-3) that allow extended stays for treatment — and Korean law protects patients' right to continuity of care during active disputes.
8. Pharmaceutical Liability and Product Liability for Medical Devices
Under the Product Liability Act (제조물 책임법, 2002), pharmaceutical companies and medical device manufacturers face strict liability for defective products that cause harm. There is no need to prove negligence — only that the product was defective and the defect caused the plaintiff's injury. The Act was amended in 2017 to impose a rebuttable presumption of defect in cases where a manufacturer cannot explain an anomalous failure of a widely distributed product.
For foreign pharmaceutical and medical device companies entering the Korean market, compliance with MFDS (Ministry of Food and Drug Safety) approval requirements is a prerequisite — and product liability exposure begins from the moment of first commercial distribution in Korea.
9. Regulatory Framework for Foreign Healthcare Investment
South Korea does not permit foreign nationals to directly own and operate hospitals under the current Medical Service Act. Hospitals must be operated by a physician (의사) or a medical corporation (의료법인). However, foreign investment is possible through:
- Equity investment in Korean medical corporations (subject to MOHW approval)
- Establishment of for-profit medical institutions in Free Economic Zones (경제자유구역) — a significant carve-out introduced in recent years
- Investment in medical equipment, health IT, and pharmaceutical distribution companies (where corporate ownership is unrestricted)
- Joint ventures with licensed Korean medical corporations
📌 Official References
Frequently Asked Questions (FAQ)
Q1: Can a foreign patient file a medical malpractice claim in Korea if they return to their home country?
Yes. A foreign patient who has returned home can still file a claim through KODIMA or Korean civil courts. Jurisdiction attaches where the medical act was performed (Korea), and Korean law will govern. You can authorize a Korean attorney to act on your behalf without being physically present. Gathering medical records before departure is strongly recommended, as Korean hospitals are required to retain records for at least 10 years.
Q2: How long do I have to file a medical malpractice claim in Korea?
The statute of limitations is 3 years from the date the patient knew or should have known of the injury and its cause, and an absolute 10-year bar from the date of the medical act (Civil Act Article 766). For criminal complaints, the statute of limitations for professional negligence causing death is 7 years. Acting promptly is essential — delays can result in loss of the right to claim.
Q3: Is mediation at KODIMA mandatory before filing a lawsuit?
Mediation is not mandatory before filing a lawsuit in court. However, since 2016, KODIMA mediation automatically commences (without hospital consent) in cases involving patient death, vegetative state, or permanent disability of more than 1 month. Choosing mediation can save significant time and legal costs — most cases resolve within 90 days compared to 1–3 years for full litigation.
Q4: Do Korean medical malpractice damages compare favorably to Western countries?
Korean non-pecuniary damages (solatium) are generally lower than in the United States or United Kingdom, but economic damages (lost income, medical costs) are calculated on a similar actuarial basis. The key difference is the absence of punitive damages in Korea — Korean civil law does not permit exemplary damages. However, recent court decisions have increased solatium awards for particularly egregious cases.
Q5: Can a foreign company invest in a Korean hospital?
Direct foreign ownership of Korean hospitals is generally prohibited outside Free Economic Zones. However, indirect investment through medical corporations, joint ventures, or special zone exemptions is possible. The Ministry of Health and Welfare (MOHW) must approve all corporate changes to medical institutions. Legal structuring advice from a qualified Korean attorney is essential before any investment.
Q6: What is the process for obtaining a medical record from a Korean hospital?
Under the Medical Service Act Article 21, patients (or their legal representatives) have the right to copy and inspect their medical records. Requests must be made in writing to the hospital's records department. The hospital must comply within a reasonable period (typically 5–10 business days). If the hospital refuses, a complaint can be filed with the Ministry of Health and Welfare or the relevant regional Medical Association.
Q7: Are there special courts or divisions for medical malpractice in Korea?
There are no dedicated medical courts in Korea. Cases proceed through the general civil court system. However, Seoul Central District Court and other major district courts have specialized civil divisions that handle complex tort cases including medical malpractice. Expert witnesses (usually senior physicians or forensic specialists) are appointed by the court to assist in evaluating technical issues.
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📋 韩国法律洞察 | 医疗与健康法
作者：律师 NOH UJIN | HANBYOL LAW LLC，首尔
韩国医疗事故与医疗法律：外国患者和投资者完整指南
韩国已成为亚洲顶级医疗旅游目的地，每年吸引数十万外国患者前来接受从整形外科到复杂肿瘤治疗等各类医疗服务。随着医疗活动的蓬勃发展，相关纠纷也随之增多。外国患者、医院投资者和制药公司必须了解韩国医疗事故和医疗法律监管的法律框架。
1. 法律框架：韩国医疗领域的主要法规
- 《医疗法》（의료법）——规范医疗执照、医院运营和医生义务。
- 《医疗事故损害救济及医疗纠纷调解法》（2012年）——设立韩国医疗纠纷调解仲裁院（KODIMA）作为专业ADR机构。
- 《药事法》（약사법）——规范药品审批、营销和药品责任。
- 《生命伦理及安全法》——规范生命伦理、临床试验和人体研究。
- 《国民健康保险法》——提供韩国全民医疗保险体系的框架。
2. 注意标准与证明医疗过失
韩国法院适用客观的注意标准，即相同专科、合理胜任的医生在类似情况下会采取的措施。要在医疗事故索赔中胜诉，原告必须证明：注意义务存在（医患关系）、违反了该义务、违反行为导致损害，以及存在可量化的损害。
韩国法院已显著降低原告的因果关系证明要求。最高法院判决（2004다13288）确立：一旦患者证明在医疗操作过程中受到伤害，举证责任转移至医疗服务提供者，由其证明不存在过失。
3. 赔偿：可获得哪些损害赔偿？
| 损害类型 | 说明 | 典型范围 |
|---|
| 误工费 | 因残疾或死亡导致未来收入能力下降 | 按精算基础计算 |
| 医疗费 | 过去和未来的治疗费用 | 实际费用 |
| 精神损害赔偿（위자료） | 非金钱性精神痛苦损害 | 2000万–1.5亿韩元 |
| 丧葬费 | 在错误死亡案件中 | 标准500万–1000万韩元 |
4. KODIMA调解程序
韩国医疗纠纷调解仲裁院（KODIMA）成立于2012年，旨在为医疗纠纷提供诉讼以外的替代方案。主要特点：申请费用低廉（1万–5万韩元），专家鉴定免费；KODIMA调解结果具有与法院判决相同的法律效力；目标在90天内完成调解。自2016年起，涉及死亡或严重残疾的案件自动启动调解，无需医院同意。
5. 医疗事故的刑事责任
在韩国，医疗专业人员可能因重大过失导致患者死亡或严重伤害而面临刑事指控。《刑法》第268条——"业务上过失致死伤"——可判处最高5年有期徒刑或最高2000万韩元罚款。
6. 知情同意要求
韩国法律规定严格的知情同意义务。医生必须以患者能够理解的方式说明：诊断结果、拟议治疗方案及其风险、替代方案和预期效果。即使手术本身没有过失，未获得适当知情同意也可能产生独立的法律责任。
7. 外国患者权利和医疗旅游
外国患者有权申请获取医疗记录（진료기록부），这对于在韩国或本国追诉索赔至关重要。医疗海外患者支持中心（해외환자지원센터）为纠纷中的外国患者提供免费法律和行政支持。
8. 药品责任与医疗器械产品责任
根据《制造物责任法》（2002年，2017年修订），制药公司和医疗器械制造商对造成伤害的缺陷产品承担严格责任——无需证明存在过失，只需证明产品存在缺陷且该缺陷导致了伤害即可。
9. 外国医疗投资监管框架
韩国不允许外国人直接拥有和经营医院。但通过自由经济区内的营利性医疗机构、韩国医疗法人的股权投资、以及合资企业等方式，外国投资是可行的。
📌 官方参考资料
常见问题解答（FAQ）
问1：外国患者回国后还能在韩国提起医疗事故索赔吗？
可以。外国患者回国后仍可通过KODIMA或韩国民事法院提起索赔。韩国法院对医疗行为发生地（韩国）具有管辖权，可授权韩国律师代理，无需亲自出庭。强烈建议在离开韩国前收集所有医疗记录。
问2：在韩国提起医疗事故索赔的时效是多久？
诉讼时效为自患者知道或应当知道伤害及其原因之日起3年，以及自医疗行为发生之日起的绝对10年除斥期间（《民法》第766条）。
问3：在提起诉讼前是否必须经过KODIMA调解？
调解并非提起诉讼的强制前提。但自2016年起，涉及患者死亡、植物人状态或超过1个月的永久性残疾的案件，KODIMA调解自动启动（无需医院同意）。选择调解通常可节省大量时间和法律费用。
问4：韩国医疗事故的损害赔偿与西方国家相比如何？
韩国的非金钱性损害赔偿（위자료）通常低于美国或英国，但经济损害（误工费、医疗费用）按类似精算基础计算。韩国民法不允许惩罚性赔偿金。
问5：外国公司能否投资韩国医院？
在自由经济区外，外国直接拥有韩国医院通常是被禁止的。但通过医疗法人、合资企业或特区豁免的间接投资是可行的，需获得保健福祉部批准。
📚 相关文章
📋 韓国法律インサイト | 医療・ヘルスケア法
弁護士 NOH UJIN | HANBYOL LAW LLC、ソウル
韓国の医療事故・ヘルスケア法：外国人患者と投資家のための完全ガイド
韓国はアジア有数の医療ツーリズム目的地として台頭しており、毎年数十万人の外国人患者が美容整形から複雑な腫瘍治療まで様々な医療サービスを求めて訪れています。この医療活動の急増に伴い、紛争も増加しています。外国人患者、病院投資家、製薬会社は、医療事故と医療規制に関する韓国の法的枠組みを理解する必要があります。
1. 法的枠組み：韓国医療分野の主要法令
- 医療法（의료법）——医療免許、病院運営、医師の義務を規定。
- 医療事故被害救済及び医療紛争調停等に関する法律（2012年）——専門的なADR機関として韓国医療紛争調停仲裁院（KODIMA）を設立。
- 薬事法（약사법）——医薬品の承認、販売、製品責任を規制。
- 生命倫理及び安全に関する法律——生命倫理、臨床試験、人体研究を規制。
- 国民健康保険法——韓国の国民健康保険制度の枠組みを提供。
2. 注意義務基準と医療過誤の立証
韓国の裁判所は、同じ専門分野の合理的に有能な医師が同様の状況下でとるべき行動に基づく客観的な注意義務基準を適用します。医療事故請求で勝訴するには、注意義務の存在、違反、因果関係、損害の4要素を立証する必要があります。
最高裁判所判決（2004다13288）では、医療行為中に患者が負傷したことを立証すれば、過失がないことの立証責任は医療提供者側に転換されると判示しました。
3. 賠償：利用可能な損害賠償は？
| 損害の種類 | 内容 | 典型的な範囲 |
|---|
| 逸失利益 | 障害または死亡による将来の収入能力の低下 | 保険数理に基づいて計算 |
| 医療費 | 過去および将来の治療費用 | 実際の費用 |
| 慰謝料（위자료） | 非金銭的な精神的苦痛に対する損害賠償 | 2000万〜1億5000万ウォン |
| 葬儀費用 | 不法死亡の場合 | 標準500万〜1000万ウォン |
4. KODIMA調停手続き
韓国医療紛争調停仲裁院（KODIMA）は2012年に設立され、医療紛争の代替手段を提供しています。申請費用は1万〜5万ウォンと低廉で、専門家鑑定は無料です。目標は90日以内に調停を完了することです。2016年以降、死亡または重篤な障害を伴うケースでは病院の同意なしに自動的に調停が開始されます。
5. 医療過誤に対する刑事責任
韓国では、重大な過失により患者が死亡または重傷を負った場合、医療専門家は刑事告発を受ける可能性があります。刑法第268条「業務上過失致死傷」は最高5年の懲役または最高2000万ウォンの罰金に処せられます。
6. インフォームドコンセント要件
韓国法は厳格なインフォームドコンセント義務を課しています。医師は患者が理解できる方法で、診断、提案された治療法とそのリスク、代替案および予期される結果を説明しなければなりません。適切なインフォームドコンセントなしで行った手術が過失なく行われた場合でも、開示されていないリスクが現実化した場合に独立した法的責任が生じる可能性があります。
7. 外国人患者の権利と医療ツーリズム
外国人患者は申請により医療記録（진료기록부）を取得する権利があります。海外患者支援センター（해외환자지원센터）は紛争中の外国人患者に無料の法律・行政支援を提供しています。
8. 医薬品責任と医療機器の製造物責任
製造物責任法（2002年、2017年改正）に基づき、製薬会社と医療機器メーカーは有害を引き起こした欠陥製品について厳格責任を負います。過失の証明は不要で、製品に欠陥があり、その欠陥が原告の負傷を引き起こしたことを証明するだけで足ります。
9. 外国医療投資の規制枠組み
韓国では外国人が直接病院を所有・経営することはできません。ただし、自由経済区内の営利医療機関の設立、韓国医療法人への株式投資、ライセンスを持つ韓国医療法人との合弁事業などを通じた投資は可能です。
📌 公式参照リソース
よくある質問（FAQ）
Q1：帰国後も韓国で医療事故請求を行えますか？
はい。帰国後もKODIMAまたは韓国民事裁判所を通じて請求を行うことができます。韓国の法律が適用され、韓国の弁護士に代理権を与えることができます。出発前に医療記録を収集することを強くお勧めします。
Q2：韓国での医療事故請求の時効は？
患者が損害とその原因を知ったまたは知るべきだった日から3年、医療行為の日から絶対的な10年の除斥期間があります（民法第766条）。
Q3：訴訟を提起する前にKODIMA調停は必須ですか？
訴訟前の調停は必須ではありません。ただし2016年以降、患者の死亡、植物状態、または1ヶ月以上の永続的障害を含むケースでは、病院の同意なしに自動的にKODIMA調停が開始されます。
Q4：韓国の医療事故損害賠償は西洋諸国と比べてどうですか？
韓国の慰謝料は米国や英国より一般的に低いですが、経済的損害（逸失利益、医療費）は同様の保険数理基準で計算されます。韓国民法には懲罰的損害賠償がありません。
Q5：外国企業は韓国の病院に投資できますか？
自由経済区外での外国直接所有は一般的に禁止されています。医療法人、合弁企業、または特区免除を通じた間接投資は可能で、保健福祉部の承認が必要です。
📚 関連記事
📋 Análisis Jurídico Coreano | Derecho Sanitario y Negligencia Médica
Por el Abogado NOH UJIN | HANBYOL LAW LLC, Seúl
Negligencia Médica y Derecho Sanitario en Corea: Guía Completa para Pacientes Extranjeros e Inversores
Corea del Sur se ha consolidado como uno de los principales destinos de turismo médico en Asia, atrayendo a cientos de miles de pacientes extranjeros cada año para procedimientos que van desde cirugía estética hasta tratamientos oncológicos complejos. Con este auge en la actividad médica, los conflictos también han aumentado. Los pacientes extranjeros, los inversores hospitalarios y las empresas farmacéuticas deben comprender el marco legal coreano que regula la negligencia médica y la sanidad.
1. Marco Legal: Principales Estatutos que Rigen la Sanidad en Corea
- Ley de Servicios Médicos (의료법)——Regula la licencia médica, la operación hospitalaria y las obligaciones de los médicos.
- Ley de Remediación de Daños por Accidentes Médicos y Mediación de Disputas Médicas (2012)——Establece KODIMA como organismo especializado de ADR.
- Ley de Asuntos Farmacéuticos (약사법)——Regula la aprobación de medicamentos, el marketing y la responsabilidad farmacéutica.
- Ley de Bioética y Seguridad——Regula la bioética, los ensayos clínicos y la investigación con sujetos humanos.
- Ley Nacional de Seguro de Salud——Proporciona el marco del sistema de salud universal de Corea.
2. Estándar de Cuidado y Prueba de Negligencia Médica
Los tribunales coreanos aplican un estándar objetivo de cuidado basado en lo que un médico razonablemente competente en la misma especialidad haría en circunstancias similares. El Tribunal Supremo coreano (Sentencia 2004다13288) estableció que una vez que el paciente demuestra que ocurrió una lesión durante un procedimiento médico, la carga de la prueba se traslada al proveedor de atención médica.
3. Indemnización: ¿Qué Daños Están Disponibles?
| Tipo de Daño | Descripción | Rango Típico |
|---|
| Pérdida de Ingresos | Capacidad de ingresos futuros reducida por discapacidad o muerte | Calculado en base actuarial |
| Gastos Médicos | Costos de tratamiento pasados y futuros | Costos reales probados |
| Daño Moral (위자료) | Daños no pecuniarios por angustia emocional | 20M–150M KRW por caso |
| Gastos Funerarios | En casos de muerte por negligencia | 5M–10M KRW estándar |
4. El Proceso de Mediación de KODIMA
KODIMA fue establecido en 2012 para proporcionar una alternativa al litigio pleno. Las tarifas de presentación son nominales (10,000–50,000 KRW) y el examen de expertos es gratuito. KODIMA aspira a completar la mediación en 90 días. Desde 2016, el inicio automático aplica en casos de muerte o discapacidad grave sin necesidad del consentimiento del hospital.
5. Responsabilidad Penal por Negligencia Médica
En Corea, los profesionales médicos pueden enfrentar cargos penales por negligencia grave que resulte en muerte o lesión grave del paciente. El Artículo 268 del Código Penal — "negligencia profesional que causa muerte o lesión" — es punible con hasta 5 años de prisión o multa de hasta 20 millones de KRW.
6. Requisitos de Consentimiento Informado
La ley coreana impone estrictas obligaciones de consentimiento informado. Los médicos deben explicar al paciente en términos comprensibles: el diagnóstico, el tratamiento propuesto y sus riesgos, las alternativas y los resultados esperados. El incumplimiento puede generar responsabilidad independiente incluso si el procedimiento se realizó sin negligencia.
7. Derechos del Paciente Extranjero y Turismo Médico
Los pacientes extranjeros tienen derecho a obtener sus registros médicos (진료기록부) a petición. El Centro de Apoyo al Paciente Extranjero (해외환자지원센터) proporciona asistencia legal y administrativa gratuita en disputas.
8. Responsabilidad Farmacéutica y de Dispositivos Médicos
Bajo la Ley de Responsabilidad del Producto (2002, reformada 2017), las empresas farmacéuticas y los fabricantes de dispositivos médicos enfrentan responsabilidad estricta por productos defectuosos que causan daño. No es necesario probar negligencia, solo que el producto era defectuoso y el defecto causó la lesión del demandante.
9. Marco Regulatorio para la Inversión Extranjera en Sanidad
Corea del Sur no permite que ciudadanos extranjeros posean y operen hospitales directamente. Sin embargo, la inversión extranjera es posible a través de Zonas Económicas Libres, inversión en corporaciones médicas coreanas (con aprobación del MOHW), y empresas conjuntas.
📌 Referencias Oficiales
Preguntas Frecuentes (FAQ)
P1: ¿Puede un paciente extranjero presentar una reclamación por negligencia médica en Corea si ya regresó a su país?
Sí. Un paciente extranjero que ha regresado a casa puede presentar una reclamación a través de KODIMA o los tribunales civiles coreanos. Se puede autorizar a un abogado coreano para actuar en su nombre sin estar físicamente presente. Se recomienda encarecidamente recopilar los registros médicos antes de partir.
P2: ¿Cuánto tiempo tengo para presentar una reclamación por negligencia médica en Corea?
El plazo de prescripción es de 3 años desde que el paciente supo o debió saber de la lesión y su causa, y un límite absoluto de 10 años desde la fecha del acto médico (Artículo 766 del Código Civil).
P3: ¿Es obligatoria la mediación en KODIMA antes de presentar una demanda?
La mediación no es obligatoria antes de presentar una demanda. Sin embargo, desde 2016, la mediación de KODIMA se inicia automáticamente (sin el consentimiento del hospital) en casos que involucran muerte del paciente, estado vegetativo o discapacidad permanente de más de 1 mes.
P4: ¿Cómo se comparan las indemnizaciones por negligencia médica en Corea con las de países occidentales?
Los daños no pecuniarios (위자료) en Corea son generalmente menores que en Estados Unidos o el Reino Unido, pero los daños económicos (lucro cesante, costes médicos) se calculan sobre una base actuarial similar. El derecho civil coreano no permite daños punitivos.
P5: ¿Puede una empresa extranjera invertir en un hospital coreano?
La propiedad directa extranjera de hospitales coreanos generalmente está prohibida fuera de las Zonas Económicas Libres. La inversión indirecta a través de corporaciones médicas, empresas conjuntas o exenciones de zonas especiales es posible con aprobación del MOHW.
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