Healthcare: Medical Devices 2026 Comparisons

Medical Devices (Including Software as a Medical Device (SaMD))

In Japan, medical devices, including Software as a Medical Device (SaMD), are primarily regulated under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the “PMD Act”). In vitro diagnostic products (IVDs) are also regulated under the PMD Act; and, although they are legally classified as a category of pharmaceuticals, IVDs are subject to many regulatory requirements comparable to those applicable to medical devices.

A medical device is defined as an instrument, apparatus or other article (including software) intended for the diagnosis, treatment or prevention of disease, or intended to affect the structure or function of the human body or that of animals, as specified by Cabinet Order. Whether a product constitutes a medical device is determined in light of its intended purpose, claimed functions, mechanism of action, labelling, advertising and other relevant factors, rather than its physical form or product name alone.

Medical devices are classified into four risk classes (Class I to Class IV) based primarily on the degree of potential risk associated with their intended use and potential harm posed to patients if the product malfunctions. Depending on the relevant classification, products are subject to notification, third-party certification (where applicable certification standards have been established) or pre-market approval by the Minister of Health, Labour and Welfare following a scientific review conducted by the Pharmaceuticals and Medical Devices Agency (PMDA).

Business operators engaged in the marketing, manufacture or distribution of medical devices must obtain the relevant licences, registrations or notifications prescribed under the PMD Act. Marketing authorisation holders (MAHs) and manufacturers are also subject to quality management requirements under the Quality Management System (QMS) Ordinance and post-market safety management obligations under the Good Vigilance Practice (GVP) Ordinance. Detailed requirements relating to marketing business licences, manufacturing, quality management and post-market surveillance are discussed in 2. Commercialisation and Product Life Cycle.

Software that independently performs a medical function and meets the statutory definition of a medical device may be regulated as SaMD, irrespective of whether it incorporates artificial intelligence (AI), augmented reality (AR) or virtual reality (VR). The applicable regulatory pathway depends on the software’s intended medical purpose and risk classification rather than the underlying technology.

Personal Protective Equipment (PPE)

Japanese law does not establish a single regulatory framework applicable to PPE as a whole. Where PPE, such as surgical masks or medical gloves, is intended for medical use and satisfies the statutory definition of a medical device, it is regulated under the PMD Act. PPE intended primarily to protect workers from occupational hazards is principally regulated under the Industrial Safety and Health Act.

Medical Instruments

Japanese law does not establish a separate regulatory category for “medical instruments”. Products falling within this description are generally regulated as medical devices where they satisfy the statutory definition of a medical device under the PMD Act. Accordingly, the applicable regulatory requirements depend on the product’s intended purpose and risk classification.

In Vitro Diagnostic Products (IVDs)

IVDs are reagents and related products used to examine specimens derived from the human body for the purpose of diagnosing diseases or assessing health conditions. Although legally classified as pharmaceuticals under the PMD Act, they are regulated under a framework broadly comparable to that applicable to medical devices, including risk-based pre-market review, quality management and post-market safety requirements.

Cosmetics

Cosmetics are primarily regulated under the PMD Act. Under the PMD Act, a cosmetic is defined as a product intended to be applied to the human body for the purpose of cleansing, beautifying, enhancing attractiveness, altering appearance, or maintaining the skin or hair in a healthy condition, provided that its effects on the human body are mild.

Although the overall regulatory framework for cosmetics under the PMD Act is similar to that applicable to pharmaceuticals, the regulatory requirements are generally less stringent. For example, cosmetics are not subject to a wholesale distribution licensing regime or to the GMP requirements applicable to pharmaceuticals.

Biocides

Japan does not have a single legal category or comprehensive regulatory regime corresponding to “biocides”. Instead, the relevant legislation and product classification are determined on a case-by-case basis, taking into account the product’s intended use, ingredients and claimed efficacy or effects.

For example, insecticides, rodenticides, repellents and similar products intended to control pests for the protection of human or animal health may be regulated as pharmaceuticals or quasi-drugs under the PMD Act. Products used to disinfect medical devices, as well as antiseptics and disinfectants intended for use on the human body, may also be regulated under the PMD Act as pharmaceuticals, quasi-drugs or medical devices, depending on their intended use and claims.

By contrast, products intended to control pests and diseases affecting agricultural crops are regulated under the Agricultural Chemicals Regulation Act, while certain household and chemical products are subject to other relevant legislation. Accordingly, businesses seeking to place biocidal products on the Japanese market should carefully assess the relevant legislation and product classification for each product.

Food, Including Gene-Edited Foods, Genetically Modified Foods (GM Foods) and Dietary Supplements

Food products are primarily regulated under the Food Sanitation Act and the Food Labelling Act. In addition, the Health Promotion Act establishes regulatory frameworks for foods bearing health claims, including Foods for Specified Health Uses (FOSHU), Foods with Nutrient Function Claims (FNFC) and Foods with Function Claims (FFC).

GM foods are subject to mandatory pre-market safety assessment. Gene-edited foods that do not contain inserted foreign nucleic acids in the final product are, in principle, not subject to mandatory pre-market approval; although, notification and consultation requirements may apply. However, prior consultation with, and notification to, the Ministry of Health, Labour and Welfare (MHLW) are required before such products are placed on the market.

Dietary supplements are not recognised as a separate legal category under Japanese law. Depending on their ingredients, intended use and claimed efficacy or effects, they may be regulated as foods, pharmaceuticals or quasi-drugs. Therapeutic claims cannot be made regarding products marketed as foods that would cause them to be regarded as pharmaceuticals under the PMD Act.

Pharmaceuticals

In Japan, pharmaceuticals are primarily regulated under the PMD Act. A pharmaceutical is generally defined as a substance intended for use in the diagnosis, treatment or prevention of disease, or intended to affect the structure or function of the human body or that of animals, excluding products regulated as medical devices, regenerative medical products or other categories under the PMD Act.

Pharmaceuticals are subject to different distribution categories, and may be classified as either prescription medicines or over-the-counter (OTC) medicines, depending on their safety profile and the level of professional regulatory supervision required for their appropriate use. Prescription medicines may only be supplied pursuant to a physician’s or dentist’s prescription, whereas OTC medicines may be sold directly to consumers subject to the applicable risk-based distribution requirements.

The manufacture, marketing and distribution of pharmaceuticals are subject to comprehensive regulation under the PMD Act. MAHs must obtain the appropriate marketing business licence and are responsible for the quality, efficacy and safety of the products they place on the market. Pharmaceutical manufacturers are also subject to licensing or registration requirements, as applicable.

Before a new pharmaceutical may be marketed in Japan, it generally requires marketing approval from the Minister of Health, Labour and Welfare following a scientific review conducted by the PMDA. MAHs and manufacturers must also comply with the applicable Good Manufacturing Practice (GMP), Good Quality Practice (GQP) and Good Vigilance Practice (GVP) requirements. Detailed requirements relating to marketing approval, manufacturing and post-marketing regulation are discussed in 2. Commercialisation and Product Life Cycle.

Vaccines

Vaccines are regulated as pharmaceuticals under the PMD Act and are generally subject to the same regulatory framework as other prescription medicines. In addition, the administration of vaccines under Japan’s public immunisation programme is governed by the Immunisation Act, which establishes the legal framework for routine and voluntary vaccinations and the responsibilities of national and local governments.

Orphan Drugs

Japan has established a designation system for orphan drugs intended for the treatment of rare diseases with high unmet medical needs. Designated orphan drugs may benefit from regulatory incentives, including priority consultation and review, financial support for development, and extended re-examination periods, provided that the applicable statutory requirements are satisfied.

Blood Products

Blood products are regulated as pharmaceuticals under the PMD Act and depending on their characteristics, may also be designated as biological products or specified biological products. Additional requirements relating to traceability and post-marketing safety apply to such products. Blood products are also subject to the Act on Securing a Stable Supply of Safe Blood Products.

Psychedelics

Most psychedelic substances are controlled under the Narcotics and Psychotropics Control Act and are not approved as pharmaceuticals in Japan. Clinical research involving psychedelic substances may nevertheless be conducted where permitted under applicable laws and regulations and subject to the necessary governmental approvals.

Cannabidiol (CBD) When Used for Medicinal Purposes

CBD intended for medicinal use is subject to the applicable pharmaceutical regulatory framework where it constitutes a pharmaceutical under the PMD Act. In addition, cannabis-derived products are subject to regulation under the applicable cannabis and narcotics legislation. Following amendments that came into force in 2024, the regulatory framework shifted from controlling the source of CBD to regulating tetrahydrocannabinol (THC) content, thereby permitting compliant CBD products while maintaining strict controls on THC.

Medical Apps

The applicable regulatory regime for medical apps depends on their intended use and functions. Software intended for the diagnosis, treatment or prevention of diseases is regulated as SaMD under the PMD Act. In contrast, apps intended solely for general health management or wellness are generally outside the scope of the PMD Act.

Telemedicine

Telemedicine constitutes medical practice performed by physicians and is regulated under the Medical Practitioners Act and the Medical Care Act. Although in-person consultation remains the basic principle in Japan, telemedicine is permitted subject to certain requirements. The MHLW has issued the Guidelines for the Appropriate Implementation of Online Medical Care, which set out the principles and key considerations for the appropriate provision of telemedicine. Where software or devices used in telemedicine qualify as medical devices under the PMD Act, they are also subject to regulation under the PMD Act.

Wearables

The regulatory regime applicable to wearable devices depends on their intended use. Devices intended for the diagnosis, treatment or prevention of diseases are regulated as medical devices under the PMD Act. In contrast, devices intended solely for general health management, exercise or fitness purposes are generally not regulated as medical devices.

Personalised Medicine

Products used in personalised medicine involving genetic analysis are regulated under the PMD Act as pharmaceuticals, medical devices or regenerative medical products, depending on their intended purpose and characteristics. In addition, the provision of regenerative medicine is subject to the Medical Practitioners Act, the Medical Care Act, and the Act on the Safety of Regenerative Medicine.

Medicines and Medical Devices

Under the PMD Act, products intended for the diagnosis, treatment or prevention of diseases, or intended to affect the structure or function of the human body, are classified either as pharmaceuticals or medical devices. Products consisting of machinery, instruments or software are generally classified as medical devices, while products of other forms are generally classified as pharmaceuticals.

Medical Devices and Lifestyle Products

The distinction between medical devices and lifestyle products depends primarily on whether the product is intended for the diagnosis, treatment or prevention of diseases, or to affect the structure or function of the human body. Where such intended use is demonstrated by the product’s performance, mechanism of action, labelling, advertising or other relevant factors, machinery, instruments and software are regulated as medical devices under the PMD Act. Products without such intended use generally fall outside the scope of the PMD Act.

Dietary Supplements/Food Products and Pharmaceuticals

Whether dietary supplements or food products are regulated as pharmaceuticals depends on their ingredients, mechanism of action and intended use as indicated by their labelling and advertising. Products claiming pharmaceutical efficacy, such as the diagnosis, treatment or prevention of diseases or effects on the structure or function of the human body, may be classified as pharmaceuticals and become subject to the PMD Act. Products without such claims are generally regulated as food rather than pharmaceuticals. Accordingly, advertising non-pharmaceutical products using medicinal claims may constitute a violation of the PMD Act.

Personal Protective Equipment (PPE), Cosmetics and Other Products

Personal protective equipment (PPE), cosmetics and biocidal products are classified according to their intended use, mode of action, ingredients, labelling and other relevant characteristics. Depending on these factors, PPE may be regulated as pharmaceuticals, medical devices, cosmetics, quasi-drugs or other product categories under the applicable Japanese laws.

Marketing Business Licence

Any business operator seeking to place medical devices on the Japanese market must obtain a marketing business licence under the PMD Act. Marketing business licences are classified into three categories corresponding to the risk classification of the products handled:

• Class I (for specially controlled medical devices (Risk Class III and IV));
• Class II (for controlled medical devices (Risk Class II)); and
• Class III (for general medical devices (Risk Class I)).

Marketing Authorisation Holders (MAHs) must appoint a Medical Device Marketing Supervision Manager who oversees all manufacturing and quality management operations, including product release decisions.

Manufacturing Registration

Any entity engaged in the manufacture of medical devices must register each manufacturing site under the PMD Act. The manufacturing processes subject to registration are prescribed by the Enforcement Regulation. Foreign entities manufacturing medical devices for the Japanese market must also obtain registration as a registered foreign medical device manufacturer.

Quality Management Requirements Under the QMS Ordinance

MAHs and manufacturers must establish and maintain a quality management system (QMS) in accordance with the QMS Ordinance (Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Products, MHLW Ordinance No 169 of 2004). The QMS Ordinance is aligned with ISO 13485 and establishes requirements concerning:

• documentation of the QMS;
• management responsibility;
• resource management;
• product realisation; and
• measurement, analysis and improvement.

MAHs must also appoint a Domestic Quality Assurance Manager responsible for quality management operations and product release decisions. In addition, the QMS Ordinance requires reporting of malfunctions and adverse events, and co-ordination with the requirements under the Good Vigilance Practice (GVP) Ordinance governing post-market safety management.

During the marketing approval process, the PMDA conducts QMS conformity assessments to verify that manufacturing sites comply with the QMS Ordinance. Japan participates in the Medical Device Single Audit Program (MDSAP), which enables the utilisation of audit results from MDSAP-recognised auditing organisations to a certain extent.

Entity Responsible for Overall Compliance

Under the PMD Act, the MAH is the entity primarily responsible for regulatory compliance with respect to the products it places on the market. The MAH bears responsibility for both product quality (under the QMS framework) and safety (under the GVP framework), with the Medical Device Marketing Supervision Manager overseeing these functions. Marketing business licences are granted by prefectural governors, and applicants must satisfy requirements relating to the location of their business premises and other matters. In the case of foreign-manufactured medical devices, a Designated Marketing Authorisation Holder must be appointed in Japan.

Japan does not have a single comprehensive legislative framework specifically governing corporate social responsibility, environmental obligations or sustainability throughout the product life cycle of medical devices. Nevertheless, several environmental laws of general application are relevant to manufacturers of medical devices and consumer health products.

The Act on Promotion of Resource Circulation for Plastics promotes environmentally conscious product design, reduction of single-use plastics, and collection and recycling. In 2026, the government began granting certifications under this Act’s design certification scheme, including for cosmetic containers. Although this framework is not specifically targeted at medical devices, manufacturers of healthcare and consumer products should increasingly take life cycle, packaging and recyclability considerations into account.

More broadly, Japan is strengthening its circular-economy policies, including measures promoting recycled materials and environmentally friendly product design. Certain listed companies are required to disclose sustainability information in their annual securities reports, and medical device companies are also expected to comply with these requirements.

Environmental claims that are false or likely to mislead consumers may be regulated as representations that state significant superiority to the actual product under the Act against Unjustifiable Premiums and Misleading Representations (the “Premiums and Representations Act”). Businesses that make unsubstantiated environmental claims may be subject to cease-and-desist orders or surcharge payment orders under this Act.

Overview of Advertising Regulations

Advertising of medical devices is strictly regulated under the PMD Act. The PMD Act prohibits false or exaggerated advertising relating to the name, manufacturing method, efficacy, effects or performance of medical devices. It also prohibits the advertising, description or dissemination of publications that could be misunderstood as constituting a guarantee by a physician or other person. Furthermore, advertising of medical devices that have not received marketing approval or certification is prohibited.

Advertising Standards

The MHLW has issued the Standards for Appropriate Advertising of Pharmaceuticals, which apply equally to medical devices. These standards restrict claims relating to efficacy, performance and safety, limit advertising of medical-use medical devices, prohibit advertisements involving disparaging comments on competitors’ products, and restrict endorsements by medical professionals. In addition, the Japan Federation of Medical Devices Associations has established the Medical Device Industry Promotion Code as a voluntary industry standard.

Surcharge System

Under the surcharge system introduced by the 2021 amendment to the PMD Act, entities that engage in false or exaggerated advertising may be subject to a surcharge payment order. The surcharge is calculated at 4.5% of total sales revenue from the offending product during the statutory calculation period. This system serves as an economic deterrent in addition to the existing criminal penalties.

Relationship With the Premiums and Representations Act

Medical device advertising is also subject to the Premiums and Representations Act, which is administered by the Consumer Affairs Agency. The Act prohibits representations that claim significant superiority to the actual product (misleading superiority) or significantly more advantageousness than the actual terms (misleading advantageousness). Violations may result in cease-and-desist orders or surcharge payment orders. Environmental claims that are false or misleading may also be regulated as misleading superiority representations under this Act.

Pre-Market Requirements: Approval, Certification and Notification

As discussed in 1. Applicable Product Safety Regulatory Regimes, medical devices are subject to pre-market approval by the Minister of Health, Labour and Welfare (for Class III and IV devices), third-party certification by a Registered Certification Body (for most Class II medical devices), or notification (for Class I medical devices), depending on their risk classification.

For products requiring approval, the applicant must undergo scientific review by the PMDA and obtain marketing approval from the Minister. The review process requires submission of data demonstrating quality, efficacy and safety, and a QMS conformity assessment is also conducted. For products requiring certification, a Registered Certification Body registered by the Minister conducts the certification review.

For Software as a Medical Device (SaMD), a two-step approval approach has been introduced, enabling staged expansion of the approved scope based on post-market data accumulation. The PMDA has also implemented a pilot programme for prioritised review of SaMD products.

Safety and Conformity Assessment

The pre-market review process includes an assessment of conformity with the Essential Principles for medical devices, which set out fundamental requirements relating to the design, manufacture, performance and safety of medical devices. The Essential Principles have been revised to explicitly require that products be designed and manufactured so as to ensure the reproducibility, reliability and performance appropriate to their intended purpose.

To market medical devices in Japan, a domestic MAH must hold a marketing business licence under the PMD Act and obtain the applicable approval or complete the applicable notification procedures. For foreign-manufactured medical devices, registration of the foreign manufacturer and appointment of a domestic MAH (including a Designated Marketing Authorisation Holder where applicable) are required.

From the perspective of international regulatory harmonisation, Japan participates in the International Medical Device Regulators Forum (IMDRF) and is committed to the alignment of medical device regulatory requirements internationally. In particular, Japan participates in the MDSAP, which promotes the mutual utilisation of third-party audit results based on common audit criteria among participating countries (Japan, the United States, Canada, Australia and Brazil).

The PMDA opened an Asia office in Bangkok, Thailand in the summer of 2024 and a Washington, DC office in the winter of 2024. These offices facilitate outreach to overseas start-up companies and strengthen co-operation with foreign regulatory authorities, including the US Food and Drug Administration (FDA).

With respect to customs and trade, standard import procedures apply to medical devices, and tariff preferences may be available under Japan’s network of Economic Partnership Agreements (EPAs). Foreign manufacturers seeking to enter the Japanese market should note that the process requires the following:

• foreign manufacturer registration;
• appointment of a domestic MAH;
• PMDA review; and
• QMS conformity assessment.

The time and cost associated with these approval and certification procedures are important practical considerations for market entry planning.

Post-Market Safety Management Obligations

MAHs must conduct post-market safety management activities in accordance with the GVP Ordinance (Ordinance on Standards for Post-Marketing Safety Management of Pharmaceuticals, Quasi-Pharmaceutical Products, Cosmetics, Medical Devices and Regenerative Medicine Products, MHLW Ordinance No 135 of 2004). This includes the collection and assessment of safety information and the implementation of necessary safety measures.

The GVP Ordinance also requires systematic post-market surveillance, defined as the collection and analysis of information obtained from the marketing of medical devices.

Record-Keeping Requirements

The GVP Ordinance prescribes record retention periods. Records relating to designated maintenance-controlled medical devices must be retained for 15 years, while records relating to other medical devices must be retained for five years.

Corrective Actions and Recalls

Where a quality deficiency or safety concern is identified, the MAH must implement corrective actions. The GVP Ordinance requires both corrective actions (measures to eliminate the cause of a non-conformity to prevent recurrence) and preventative actions (measures to eliminate the cause of a potential non-conformity to prevent occurrence).

Recalls may be implemented voluntarily by the MAH or pursuant to an order from the MHLW or prefectural governors. The MHLW or prefectural governors may order the recall of medical devices where necessary to prevent the occurrence or spread of harm to public health.

Notification to PMDA

MAHs must report to the PMDA upon becoming aware of malfunctions or adverse events relating to their medical devices. Reportable events include health damage or the risk thereof arising from product malfunctions, as well as recall measures taken in foreign jurisdictions.

Information to Consumers and Healthcare Professionals

The PMD Act establishes several mechanisms to ensure that adequate safety information is made available to users and healthcare professionals.

MAHs are required to electronically publish precautionary information – including directions for use, maintenance and inspection matters, and other information necessary for safe use – through the PMDA’s website. Following the 2021 amendment to the PMD Act, the system transitioned from paper-based package inserts to electronic publication of precautionary information. This enables healthcare professionals and users to access the latest safety information at any time through the PMDA’s Medical Product Information website.

Urgent or significant safety information is communicated rapidly to healthcare institutions through Emergency Safety Information (commonly known as a “Yellow Letter”) or Rapid Safety Communications (commonly known as a “Blue Letter”), which are issued in accordance with the applicable MHLW/PMDA safety communication framework. These communications are designed to promptly alert healthcare professionals to serious adverse reactions or malfunctions.

The principal regulatory authorities involved in the oversight of medical devices and related healthcare products in Japan are as follows.

Ministry of Health, Labour and Welfare (MHLW)

The MHLW is the central government ministry responsible for administering the PMD Act. It formulates policy and administers legislation concerning the quality, efficacy and safety of medical devices and other healthcare products. Marketing approval authority rests with the Minister of Health, Labour and Welfare, who also has the power to establish standards and take administrative actions including licence revocation, business suspension orders and orders relating to recalls and other safety measures where authorised by the PMD Act.

Pharmaceuticals and Medical Devices Agency (PMDA)

The PMDA is an independent administrative agency established under the PMD Act and serves as the principal operational body for the review, inspection and safety oversight of medical devices. Its core functions include:

• marketing approval reviews for new and improved medical devices;
• QMS conformity assessments of manufacturing sites;
• post-market safety management, including the collection, analysis and evaluation of adverse event and malfunction reports; and
• consultation services for companies during product development.

Prefectural Governors

Prefectural governors are responsible for granting certain marketing and manufacturing licences and registrations, sales licences, and day-to-day supervision within their jurisdictions. They have the authority to conduct on-site inspections and to take administrative actions such as business suspension orders.

Administrative Oversight Powers

The Minister of Health, Labour and Welfare, and prefectural governors exercise statutory supervisory and enforcement powers, with the PMDA providing regulatory review, inspection and safety-related support functions. These include the authority to conduct on-site inspections, request reports, and question relevant persons in order to ensure compliance with quality, efficacy and safety requirements.

Administrative Enforcement Measures

The PMD Act provides regulators with a wide range of administrative enforcement measures, including the following.

• Improvement orders – the MHLW may order an MAH to improve its quality management system (QMS) or post-market safety management methods where they do not conform to the applicable standards, and may order a suspension of all or part of the business until the improvement is implemented. Prefectural governors have corresponding authority over manufacturers and other operators.
• Business operation improvement orders – where a violation of the PMD Act or related Cabinet Orders and Ministerial Ordinances has occurred and measures are necessary to prevent the occurrence or spread of harm to public health, the MHLW or prefectural governors, as applicable, may order the measures necessary to improve business operations.
• Advertising violation orders – the MHLW or prefectural governors may order persons who have violated the prohibition on false or exaggerated advertising or the prohibition on advertising unapproved medical devices to cease the violation, take measures necessary to prevent recurrence, make public announcements, or take other measures sufficient to prevent harm to public health.
• Licence revocation and business suspension orders – the MHLW or prefectural governors, as applicable, may revoke the marketing or manufacturing licence of an MAH or manufacturer, or order a suspension of all or part of the business for a specified period, where the operator has violated the PMD Act or related Cabinet Orders and Ministerial Ordinances. Prefectural governors have corresponding authority over distributors and lessors.
• Disposal and recall orders – the MHLW or prefectural governors may order the disposal, recall or other measures sufficient to prevent public health hazards with respect to medical devices that violate applicable standards or whose approval has been revoked. Where the order is not complied with or urgent necessity exists, regulatory officials may directly carry out the disposal or recall.
• Emergency orders – the MHLW may order MAHs, manufacturers, distributors or other operators to temporarily suspend the sale, supply, lease or repair of medical devices, or to take other emergency measures, where necessary to prevent the occurrence or spread of harm to public health.

Surcharge System

As discussed in 2.3 Advertising and Product Claims, the surcharge system introduced by the 2021 amendment to the PMD Act requires violators of advertising regulations to pay 4.5% of sales revenue from the offending product.

Criminal Penalties

Serious violations of the PMD Act are subject to criminal penalties:

• certain unlicensed manufacturing, marketing or sale activities may be punished by imprisonment of up to three years or a fine of up to JPY3 million;
• advertising violations may result in imprisonment of up to two years or a fine of up to JPY2 million; and
• less serious breaches are subject to imprisonment of up to one year or a fine of up to JPY1 million.

Corporate entities are also subject to monetary penalties under dual punishment provisions.

Regulatory Offences

Product safety offences relating to medical devices, in vitro diagnostic products, pharmaceuticals, cosmetics and certain healthcare products are primarily governed by the PMD Act. Typical regulatory offences include:

• manufacturing, importing or marketing products without the required licence or marketing authorisation;
• distributing products that fail to comply with applicable quality or safety standards;
• making false or misleading claims regarding efficacy or safety;
• failing to comply with labelling requirements; and
• breaching post-market obligations such as adverse event reporting, recall obligations and record-keeping requirements.

These obligations apply to Software as a Medical Device (SaMD) and AI-based medical devices in substantially the same manner as for conventional medical devices.

Administrative and Criminal Sanctions

The PMD Act provides regulators with a wide range of administrative enforcement measures. The MHLW and prefectural authorities (with operational support from the PMDA where applicable) may:

• issue corrective action orders;
• suspend or revoke licences;
• order recalls; or
• prohibit further distribution of non-compliant products.

Serious violations may also result in criminal liability. These include:

• imprisonment for up to three years or fines of up to JPY3 million for unlicensed manufacturing or sales (Article 84);
• imprisonment for up to two years or fines of up to JPY2 million for advertising violations (Article 85); and
• imprisonment for up to one year or fines of up to JPY1 million for less serious breaches (Article 86).

Less serious offences include failures to submit mandatory notifications, maintain required records, or comply with other procedural obligations imposed under the PMD Act, which are also subject to criminal penalties. Corporate entities are also subject to monetary penalties under dual punishment provisions. In addition, the 2021 amendment introduced a surcharge system requiring violators of advertising regulations to pay 4.5% of sales revenue from the offending product.

Enforcement Practice

In practice, Japanese regulators generally seek voluntary corrective measures before resorting to criminal prosecution, particularly where companies promptly report safety issues and implement appropriate recalls. Criminal enforcement is pursued in cases involving intentional misconduct, falsification of regulatory submissions, unauthorised manufacture or distribution, or conduct creating significant risks to public health. Recent enforcement has focused on:

• misleading advertising of healthcare products;
• unauthorised marketing of medical devices (including internet sales);
• quality control deficiencies; and
• failures to comply with post-market safety management obligations.

Administrative actions, including business suspension orders and product recalls, are considerably more common than criminal prosecutions.

Representative Enforcement Examples

According to the fiscal year 2023 report of the Ministry of Economy, Trade and Industry on the improvement of commercial transaction and service environments relating to medical devices, the incidence of medical device recalls in Japan was approximately 400 cases annually on average between 2013 and 2022, with Class II (controlled medical devices under the PMD Act) medical devices accounting for the largest portion and design-related issues being the most common recall reason. Judicial precedents concerning criminal penalties under the PMD Act are relatively limited, as many violations are resolved through administrative enforcement. Nevertheless, authorities periodically announce sanctions involving unapproved medical devices, falsified manufacturing records, and misleading efficacy claims.

Legal Basis for Product Liability Claims

Product liability claims relating to medical devices, pharmaceuticals, in vitro diagnostic products, cosmetics and other healthcare products may principally be brought under the Product Liability Act (PLA). The PLA imposes strict liability on manufacturers, importers and certain entities presenting themselves as manufacturers for damage caused by a defect in a product, without requiring proof of negligence. A “defect” is assessed in light of the following:

• the nature of the product;
• its ordinarily foreseeable use; and
• the state of scientific and technical knowledge at the time of its delivery.

Claimants may also pursue claims under the Civil Code based on tort or breach of contract. Unlike claims under the PLA, tort claims generally require proof of negligence, while contractual claims are available only where a contractual relationship exists. In practice, plaintiffs often rely on multiple legal grounds in the alternative.

Impact of Technological Developments

The existing product liability framework applies equally to SaMD, AI-based medical devices and other digital health technologies where they constitute “products” for the purposes of the PLA. However, AI-based products present practical challenges in determining the existence of a defect, particularly where machine-learning algorithms evolve over time or clinical outputs depend on complex software processes. Causation may also become more difficult to establish where healthcare professionals retain discretion over clinical decision-making.

To date, Japanese courts have not established specific product liability principles applicable solely to AI-based medical devices. Accordingly, existing principles under the PLA continue to apply, while courts are expected to evaluate software defects, warnings, foreseeable use and causation on a case-by-case basis.

Legislative Developments

Japan has not introduced legislative measures specifically addressing the challenges that AI-based or adaptive medical devices present to the concept of “defect” under the PLA. In particular, there has been no reform of the statutory standard for determining whether a product lacks the safety ordinarily expected, nor any modification of the burden of proof applicable to product liability claims.

Instead, the government’s response has focused primarily on regulatory oversight under the PMD Act. The MHLW and the PMDA have introduced guidance on the evaluation, life cycle management and post-market monitoring of AI-based medical devices, aiming to ensure safety throughout the product life cycle rather than modifying the civil liability regime. Accordingly, issues relating to software defects, adaptive algorithms and causation continue to be assessed under the existing principles of the PLA on a case-by-case basis.

Domestic Jurisdiction

Product liability claims are generally brought before the Japanese civil courts under the Code of Civil Procedure. Domestic jurisdiction is determined principally by the defendant’s place of domicile or principal office. However, in product liability cases, a claimant may also commence proceedings in the court having jurisdiction over the place where the tort occurred. Japanese courts generally regard the place where the damage occurred as the place of the tort, enabling injured persons to bring claims in the jurisdiction where the injury was sustained.

International Jurisdiction

Where the defendant is a foreign manufacturer or supplier, Japanese courts may exercise international jurisdiction where a statutory ground under the Code of Civil Procedure is satisfied. In product liability disputes, jurisdiction commonly exists where the damage occurred in Japan or where the defendant has a relevant office or other jurisdictional connecting factor in Japan. Foreign companies that market products in Japan through local subsidiaries, distributors or authorised representatives may therefore become subject to proceedings before Japanese courts.

Specialised Courts and Procedure

Japan has no specialised product liability courts. Product liability claims are heard by the ordinary civil courts under the same procedural rules as other civil litigation. Medical device and pharmaceutical disputes often require extensive expert evidence concerning product defects, causation and scientific or medical issues, although there is no separate procedural framework applicable to such cases.

General Cost Rules

Product liability litigation is subject to the ordinary cost rules applicable to civil proceedings in Japan. There are no special cost rules for product liability claims. Court costs, including filing fees and certain procedural expenses, are generally borne by the unsuccessful party. By contrast, each party ordinarily bears its own attorneys’ fees, except to the limited extent that attorneys’ fees may be recoverable as part of damages in tort claims to the extent recognised by the courts.

Cost Allocation

Japan does not adopt a “loser pays” principle comparable to that applicable in some common law jurisdictions in relation to attorneys’ fees. Accordingly, the financial risk associated with unsuccessful litigation is generally lower than in jurisdictions where the losing party is required to reimburse the successful party’s legal costs.

Settlement and Cost Management

There is also no procedural mechanism equivalent to the English “without prejudice” or Part 36 offer regime, under which a party that unreasonably refuses a settlement offer may face adverse costs consequences. In practice, however, parties frequently seek to resolve product liability disputes through court-assisted settlement (judicial settlement) during litigation or through mediation before litigation commences. Particularly in technically complex medical device and pharmaceutical disputes, an early settlement may reduce litigation costs and avoid the need for extensive expert evidence.

Alternative Mechanisms

In addition to civil product liability litigation, Japan provides several administrative and public law mechanisms for addressing product-related disputes.

Administrative Review of Regulatory Decisions

Administrative dispositions under the PMD Act, including decisions relating to marketing authorisations, licence revocations, business suspension orders, recall orders and other regulatory measures, may be challenged through administrative appeals under the Administrative Complaint Review Act or through administrative litigation, including revocation actions, under the Administrative Case Litigation Act. Unlike the UK, challenges to administrative decisions in Japan are pursued through these statutory administrative appeal and litigation procedures rather than through a general judicial review procedure.

Regulatory Investigations and Information Disclosure

Where a serious product safety incident occurs, the competent authorities, including the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), the Consumer Affairs Agency, or the National Institute of Technology and Evaluation (NITE), may do the following:

• conduct investigations;
• request reports from manufacturers;
• inspect facilities; and
• order corrective measures or recalls.

The findings of such investigations may influence subsequent civil litigation or regulatory enforcement.

Information held by government agencies may be requested under the Act on Access to Information Held by Administrative Organs and the Act on Access to Information Held by Incorporated Administrative Agencies. However, unlike common law jurisdictions, Japan has no general pre-trial discovery system, and confidential business information, personal information and other protected information may be withheld from disclosure.

Medical Investigations and Expert Evidence

Japan also has no equivalent to the UK coroner’s inquest or preliminary medical assessment procedures. Nevertheless, where deaths associated with medical treatment are investigated under the Medical Care Act, the medical accident investigation system may apply. In civil litigation, courts may appoint expert commissioners or expert witnesses where permitted under the Code of Civil Procedure, although party-appointed medical and technical expert opinions remain the principal means of proving scientific issues.

Representative Cases

A prominent example was the Iressa (gefitinib) litigation concerning fatal cases of interstitial lung disease associated with an anti-cancer drug. The litigation involved not only product liability and tort claims against the manufacturer but also claims against the government concerning regulatory decisions, and prompted extensive discussions regarding post-marketing safety measures, risk communication and the adequacy of warnings. Earlier landmark cases included the HIV-contaminated blood products litigation (Yakugai AIDS) and the hepatitis C litigation, both of which resulted in extensive governmental investigations, regulatory reforms and compensation schemes.

Collective Redress Mechanisms

Japan does not recognise US-style class actions in product liability litigation. Instead, the Act on Special Measures Concerning Civil Court Proceedings for the Collective Redress of Property Damage Incurred by Consumers establishes a limited collective redress system for certain consumer claims. The procedure consists of two stages:

• first, a certified qualified consumer organisation obtains a judgment confirming the common liability of the defendant; and
• second, individual consumers participate in simplified proceedings to determine the amount of their respective claims.

The scope of this system is limited. It applies only to certain monetary claims arising from consumer contracts and is not available for claims seeking damages for personal injury or death. Consequently, most product liability claims involving pharmaceuticals, medical devices or other healthcare products continue to be pursued through individual litigation, even where multiple claimants are involved.

Representative Cases and Practice

Japan has not experienced large-scale product liability class actions comparable to those in the United States. Product-related mass harm cases, including the HIV-contaminated blood products litigation (Yakugai AIDS), the hepatitis C litigation and the Iressa litigation, were resolved through multiple individual lawsuits, joint actions, co-ordinated judicial case management and, in some cases, legislative or administrative compensation schemes, rather than through a formal class action mechanism.

Where numerous similar claims arise, Japanese courts may co-ordinate proceedings by assigning related cases to the same judicial panel, conducting joint litigation where appropriate, or otherwise co-ordinating hearings. However, unlike a class action, each claimant remains an individual party and must establish their own claim, even where the court renders a single judgment covering multiple plaintiffs.

Future Trends

Collective product liability proceedings are not expected to increase significantly in the near future. The principal reason is that the existing collective redress mechanism under the Act on Special Measures Concerning Civil Court Proceedings for the Collective Redress of Property Damage Incurred by Consumers does not extend to claims for personal injury or death, which account for most product liability disputes involving medical devices and pharmaceuticals. In addition, there are currently no significant legislative proposals to introduce a US-style class action system in Japan.

Nevertheless, increasing public awareness of product safety and the growing number of large-scale product incidents may lead to an increase in joint litigation involving multiple claimants and more co-ordinated case management by the courts. However, individual actions and joint litigation are expected to remain the principal means of resolving product liability disputes.

Available ADR Mechanisms

Japan has no ADR mechanism specifically designed for product liability disputes involving medical devices, pharmaceuticals or other healthcare products. Instead, such disputes may be resolved through the general ADR framework established under the Act on Promotion of the Use of Alternative Dispute Resolution, court-annexed civil mediation, or judicial settlement during pending litigation.

Civil mediation conducted by the courts is available where the parties wish to reach an amicable resolution with the assistance of a mediation committee. In addition, certified private ADR providers, including bar association ADR centres and other industry-specific ADR organisations, offer mediation services for a wide range of commercial and healthcare-related disputes.

Practical Use

In practice, judicial settlement is more commonly used than formal ADR in product liability disputes, particularly where court proceedings have already commenced. Medical device and pharmaceutical disputes often involve complex scientific and medical issues, and settlement discussions are frequently facilitated after the parties have exchanged expert opinions or the court has clarified the principal issues in dispute.

Although ADR may reduce the time and cost associated with litigation and help preserve commercial relationships, its effectiveness ultimately depends on the parties’ willingness to settle. Accordingly, ADR complements rather than replaces judicial proceedings in product liability disputes.

Interaction Between Civil, Criminal and Administrative Proceedings

Civil, criminal and administrative proceedings arising from the same product safety incident are legally independent but may proceed in parallel. A serious product safety incident may give rise simultaneously to civil product liability claims, administrative investigations under the PMD Act, and, in exceptional cases, criminal investigations or prosecutions.

The outcome of one type of proceeding does not legally determine the outcome of another. However, findings made during administrative investigations or criminal proceedings may subsequently be relied upon as evidence in civil litigation, subject to the applicable rules of evidence. Similarly, facts established in civil proceedings may influence regulatory enforcement where appropriate.

Unlike some jurisdictions, Japan does not provide broad pre-trial discovery. A civil claimant cannot obtain unrestricted access to criminal investigation records. However, evidence disclosed during criminal proceedings or publicly available administrative materials may be submitted in subsequent civil litigation where permitted by law.

Product Safety Compliance and Civil Liability

Compliance with applicable regulatory requirements under the PMD Act does not automatically preclude product liability under the Product Liability Act or the Civil Code. Conversely, a regulatory breach does not automatically establish civil liability. Nevertheless, regulatory compliance, including compliance with applicable manufacturing, quality management and post-market safety requirements, is frequently considered by the courts when assessing whether a product was defective or whether a manufacturer exercised appropriate care.

Access to Information

Unlike common law jurisdictions, Japan has no general pre-trial discovery system. Instead, civil claimants principally obtain evidence through procedural mechanisms available under the Code of Civil Procedure, including document production orders, requests for the transmission of documents held by public authorities or third parties, and court requests for information where appropriate. Prior to litigation, attorneys may also seek information through inquiries made under Article 23-2(2) of the Attorney Act, although responses are generally voluntary unless disclosure is required by law.

Information held by government agencies may additionally be requested under the Act on Access to Information Held by Incorporated Administrative Agencies. However, disclosure remains subject to statutory exemptions, including those protecting confidential business information, personal information and other protected interests. Personal information is primarily governed by the Act on the Protection of Personal Information, which is intended to protect personal data rather than facilitate evidence gathering for civil litigation.

Digitalisation and Product Safety

A significant policy trend in Japan is the continued adaptation of the regulatory framework to digital and software-based healthcare products. For Software as a Medical Device (SaMD), the government has introduced measures intended to facilitate faster development and market access, including a two-step approval approach, priority consultation and review, and the IDATEN framework, which allows certain post-approval modifications to be implemented pursuant to a pre-agreed change plan. These initiatives seek to accommodate products that evolve rapidly after market launch while maintaining appropriate safety oversight.

Environmental and Sustainability Considerations

Environmental considerations are also becoming increasingly relevant across product sectors. Japan’s Act on Promotion of Resource Circulation for Plastics promotes environmentally conscious product design, reduction of single-use plastics, and collection and recycling. In 2026, the government began granting certifications under the Act’s design certification scheme, including for cosmetic containers. More broadly, Japan is strengthening its circular-economy policies, including measures promoting recycled materials and environmentally friendly product design. Although these measures are not specifically targeted at medical devices, manufacturers of healthcare and consumer products should increasingly take life cycle, packaging and recyclability considerations into account.

A major recent development is the 2025 amendment to the PMD Act and related legislation. The amendments are being implemented in stages and seek to strengthen quality and safety assurance, improve the stable supply of pharmaceuticals and medical devices, and promote the development and practical application of innovative products. Among other measures, the legislation revises the conditional approval framework and introduces measures intended to support innovative pharmaceuticals and medical devices. Businesses should therefore continue to monitor implementing ordinances and MHLW notifications as the amended framework becomes fully operational.

AI in Healthcare

AI is increasingly incorporated into medical imaging, diagnostic support, disease prediction, treatment support and other digital health products in Japan. Where an AI-enabled product device meets the definition of a medical device, it is regulated under the existing PMD Act framework. Accordingly, AI does not constitute a separate medical device category; regulatory requirements depend principally on the product’s intended medical purpose and risk profile.

AI Regulation

Japan enacted the Act on Promotion of Research and Development and Utilisation of Artificial Intelligence-Related Technology in 2025. Unlike the EU legislation commonly referred to as the EU AI Act, Japan’s legislation establishes a broad national framework for promoting AI innovation while addressing risks rather than imposing a comprehensive risk-based regulatory regime on individual AI systems. The government adopted its first Artificial Intelligence Basic Plan in December 2025 and revised it in July 2026.

The AI Guidelines for Business (Version 1.2), updated in March 2026, supplement this framework through principles concerning matters such as safety, fairness, privacy, security and transparency. For medical devices and consumer health products, these horizontal AI governance measures are expected to operate alongside, rather than replace, existing sector-specific regimes. Businesses developing AI-enabled healthcare products therefore need to consider both existing healthcare/product regulation and the evolving AI governance framework.