In Japan, the product safety of medical devices, personal protective equipment (PPE) and medical instruments is primarily regulated by the Pharmaceuticals and Medical Devices Act (the “PMD Act”), as detailed below.

Medical Devices

Under the PMD Act, “medical device” is defined as “any mechanical appliance or other device intended to be used for the diagnosis, treatment or prevention of disease in humans or animals, or to affect the structure or functions of the human or animal body, excluding regenerative medicine products, as specified by Cabinet Order.” In this definition, “mechanical appliance or other device” is defined to include “programs (meaning instructions for electronic computers that are combined in such a way as to produce a specific result)”. Accordingly, software such as artificial intelligence, augmented reality or virtual reality used for the diagnosis, treatment or prevention of disease would be regulated as medical devices.

Medical devices are classified into four risk-based classes:

• Class I (General Medical Devices) – low risk;
• Class II (Controlled Medical Devices) – medium risk; and
• Classes III and IV (Highly Controlled Medical Devices) – high risk.

Depending on classification, the marketing of medical devices requires:

• notification to the Ministry of Health, Labour and Welfare (MHLW);
• third-party certification; or
• marketing authorisation from MHLW after evaluation by the Pharmaceuticals and Medical Devices Agency (PMDA).

In order to proceed with such approval process, the applicant is required to obtain the relevant business licence for marketing each category of medical device from MHLW through the competent local governments (the “Authorities”). Compliance with the requirements of the Quality Management System (QMS), which is generally aligned with ISO 13485 but includes Japan-specific requirements under the QMS Ordinance, and Good Vigilance Practice (GVP) is a prerequisite for obtaining such business licence.

Personal Protective Equipment

PPE intended to be used for medical use (eg, surgical masks, gloves) is generally treated as a medical device under the PMD Act and subject to the classification and approval process for medical devices described above. PPE for non-medical use is regulated by the Consumer Product Safety Act for consumer products and by the Industrial Safety and Health Act for workplace equipment.

Medical Instruments

Medical instruments intended for the diagnosis, treatment or prevention of disease are regulated as medical devices under the PMD Act. These are subject to the classification and approval process for medical devices described above.

In Japan, the product safety for cosmetics, biocides, foods and nutrition supplements is regulated under separate legal frameworks, as detailed below.

Cosmetics

Cosmetics are regulated under the PMD Act. The marketing of cosmetics generally requires notification to MHLW. In order to make such notification, the applicant is required to obtain the relevant business licence from MHLW through the competent Authorities. Compliance with Good Quality Practice (GQP) and GVP requirements is a prerequisite for obtaining such business licence. Cosmetics can only use approved ingredients, and medical claims are prohibited.

Biocides

Biocides are regulated by the following laws depending on their use.

• Medical disinfectants fall under the PMD Act.
• Food-contact sanitisers are regulated under the Food Sanitation Act.
• Household products like insecticides are governed by the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (commonly known as the “Chemical Substances Control Law” or CSCL) or the Poisonous and Deleterious Substances Control Act.
• Agricultural agents are regulated under the Agricultural Chemicals Regulation Act.

Foods and Nutrition Supplements

Foods, including gene-edited products and genetically modified organisms (GMOs), are regulated under the following:

• Food Sanitation Act;
• Health Promotion Act; and
• Food Labelling Act.

For gene-edited foods that do not contain foreign DNA, developers are required to submit a prior notification to MHLW. However, such products are not subject to individual pre-market approval or mandatory labelling, under current policy, though voluntary labelling is encouraged for consumer transparency. In contrast, genetically modified organisms (GMOs), which involve the insertion of foreign genes, are subject to pre-market safety assessments by MHLW and environmental risk assessments under the Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (commonly known as the “Cartagena Act”). In addition, mandatory labelling is required for designated GMO products if recombinant DNA or proteins remain in the final food product.

Nutrition supplements are treated as foods unless medical claims are made. Food products that can display functional or health benefits are limited to:

• Nutrient Function Foods;
• Foods with Function Claims (FFC); and
• Foods for Specified Health Uses (FOSHU).

Nutrient Function Foods follow a self-certification system and do not require government approval. FOSHU must be individually reviewed and approved by the government for safety and efficacy. Foods with Function Claims require prior notification to the Consumer Affairs Agency (CAA) with supporting scientific evidence but are not reviewed by the government. Businesses are responsible for proper labelling based on scientific validity.

In Japan, product safety for pharmaceuticals, blood products, psychedelics and medicinal cannabidiol (CBD) is regulated under the PMD Act and other specialised laws, as detailed below.

Pharmaceuticals

Product safety for pharmaceuticals is regulated under the PMD Act, overseen by MHLW and PMDA. Prescription drugs require clinical trials and marketing authorisation by MHLW after evaluation by PMDA, with post-marketing surveillance under GVP. OTC drugs require marketing authorisation by MHLW or the competent Authorities, depending on the product. In order to apply for marketing authorisation, the applicant is required to obtain the relevant business licence from the competent Authorities. Compliance with GQP and GVP requirements is a prerequisite for obtaining such business licence.

Blood Products

Blood products are regulated primarily under the PMD Act and the Act on Securing a Stable Supply of Safe Blood Products. Transfusion products (eg, red cells, plasma) are supplied exclusively through the Japanese Red Cross and require strict donor screening and MHLW-managed supply control. Plasma-derived products (eg, albumin, coagulation factors) are regulated as prescription drugs and require marketing authorisation, infection control measures and 20-year traceability.

Psychedelics

Psychedelics are strictly regulated as controlled substances, not standard consumer products. Laws such as the Narcotics and Psychotropics Control Act and the PMD Act’s Designated Substances System prohibit their possession, use and sale. Medical or research use is only allowed under special government licences. Unauthorised handling is subject to criminal penalty, with strict oversight for any permitted use.

Cannabidiol (CBD)

Even for medical use, CBD is subject to strict regulation under the Act on the Regulation of Cannabis Cultivation (commonly known as the “Cannabis Control Act”), the Narcotics and Psychotropics Control Act and the PMD Act. Use as a medicine requires marketing authorisation from MHLW.

Clinical Trials of Medicinal Products

In Japan, clinical trials of medicinal products are regulated under different frameworks depending on their purpose. Clinical trials for marketing authorisation are regulated by the PMD Act and must comply with Good Clinical Practice (GCP) standards, Institutional Review Board (IRB) review and PMDA notification. Specified clinical trials, regulated by the Clinical Trials Act, apply to studies involving drug interventions funded by pharmaceutical companies or using unapproved drugs, and these require MHLW notification and certified IRB approval. Non-interventional research is governed by the applicable ethical guidelines and also requires IRB review and informed consent.

In Japan, medical apps, telemedicine, wearables and stem cells are regulated under different frameworks depending on their medical purpose, risk level and function, as detailed below.

Medical Apps

Medical apps intended for the diagnosis, treatment or prevention of disease are regulated under the PMD Act. These are classified as “Program Medical Devices” (SaMD) and are generally subject to the risk-based framework for medical devices described in 1.1 Medical Devices, except that medical apps whose functions are equivalent to Class I (General Medical Devices) are excluded from the scope of medical devices. Apps used solely for wellness or data recording are generally not regulated as medical devices.

Telemedicine

Telemedicine is regulated primarily through three key frameworks:

• the Medical Practitioners Act, which governs the proper conduct of remote medical services, including restrictions on initial consultations;
• the PMD Act, which applies to medical apps or devices used in telemedicine, requiring approval and compliance with QMS and GVP; and
• the Act on the Protection of Personal Information, which mandates data security.

Wearables

Wearable devices are regulated based on their purpose and risk level. Wellness wearables (eg, fitness trackers) are not subject to the PMD Act but must comply with general safety laws like the Electrical Appliance and Material Safety Act (commonly known as the “PSE Act”) and the Radio Act. Medical wearables (eg, ECG monitors) are classified as medical devices under the PMD Act and require approval and compliance with QMS and GVP.

Stem Cells

Stem cell therapies are regulated as regenerative medical products under the PMD Act, requiring PMDA review, marketing authorisation and compliance with Good Cell and Tissue Practice (GCTP). On the other hand, clinical use of stem cells is governed by the Act on Securing Safety of Regenerative Medicine, requiring safety plans, ethics committee review and registered cell processing facilities.

In Japan, the classification of borderline products, those that may fall between regulatory categories such as medicines, medical devices, cosmetics and foods, is determined generally based on intended use, mode of action, composition and labelling claims, as detailed below.

Medicines and Medical Devices

Medicines and medical devices are classified under the PMD Act based on factors such as intended use, mechanism of action, form and labelling. Medicines act pharmacologically, while medical devices act through physical or mechanical means. Combination products are classified by their primary mode of action.

Personal Protective Equipment (PPE) and Medicines

The classification of PPE and medicines depends on intended use, mechanism of action and labelling. Medicines act pharmacologically to treat or prevent disease, while PPE provides physical protection. Some PPE, like surgical masks or medical gloves, are regulated as medical devices under the PMD Act. Claims such as “kills viruses” may require regulatory approval. Borderline products are classified based on their primary mode of action.

Cosmetics, Biocides and Medicines

Cosmetics, biocides and medicines are classified based on intended use, mechanism of action, ingredients and labelling. Medicines treat or prevent disease and require approval under the PMD Act. Cosmetics aim to beautify or cleanse without therapeutic claims. Biocides target harmful organisms and may fall under multiple laws, including the Agricultural Chemicals Act. Products that make therapeutic claims (eg, “treats acne”) are generally classified as medicines.

Medicines and Food

Medicines and food are classified based on intended use, claims, ingredients and form. Medicines are regulated under the PMD Act and are intended to treat or prevent disease, often requiring approval. Foods, governed by the Food Sanitation Act, are for general health or nutrition and cannot make medical claims. MHLW has published a list of substances that are exclusively used as medicinal ingredients and a list of substances that are not considered to be medicinal ingredients unless they claim to have medical effects.

In Japan, the manufacturing and marketing of medical devices are regulated under the PMD Act. Manufacturers must comply with detailed requirements both before and after commercialisation.

Manufacturing Site Requirements

Manufacturers of medical devices are required to register with MHLW through the competent Authorities for each manufacturing facility. Sites must comply with Good Manufacturing Practice (GMP), ensuring that products are consistently produced and controlled according to quality standards.

Product Specifications and Design Requirements

The design, specifications and manufacturing of medical devices are regulated under the PMD Act, GMP ministerial ordinances and international standards such as ISO 13485 and ISO 14971. Manufacturers must implement risk-based design controls, including design planning, input/output documentation, verification, validation, and change management. Manufacturing processes must follow GMP, including process validation, traceability, and documentation. All stages must ensure conformity with approved specifications. The Marketing Authorisation Holder (MAH) retains responsibility for product specifications, and manufacturers must comply with the MAH’s requirements. Manufacturers also support post-marketing activities, including QMS and GVP practices.

Legal and Compliance Requirements

With exceptions set forth in 1.1 Medical Devices, an MAH must be designated for medical devices sold in Japan. As a general rule, the MAH must be located in Japan and licensed under the PMD Act. It is responsible for ensuring compliance with QMS (for medical devices and in vitro diagnostic drugs) or GQP (for other healthcare products including pharmaceuticals and cosmetics) and GVP, including appointing qualified personnel for quality and safety oversight. The MAH assumes full legal responsibility for the product, even if manufacturing or importing is outsourced. A foreign manufacturer without a place of business in Japan can hold a marketing authorisation by appointing a domestic company as the Designated Marketing Authorisation Holder (DMAH).

In Japan, obligations related to corporate social responsibility (CSR), environmental protection and sustainability apply throughout the product life cycle and are shaped by both legal requirements and voluntary frameworks. These obligations are increasingly relevant to manufacturers and distributors of medical devices and consumer health products.

Legal Obligations

Several laws impose binding environmental and sustainability duties.

• The Waste Management and Public Cleansing Act mandates proper treatment and disposal of industrial and hazardous waste, including medical device components and packaging materials.
• The Act on the Promotion of Effective Utilization of Resources encourages eco-design, resource efficiency and recycling.
• The Chemical Substances Control Law (CSCL) requires risk assessments and controls for hazardous chemicals used in product manufacturing.
• The Act on the Rational Use of Energy and the Act on Promotion of Global Warming Countermeasures impose energy efficiency standards and emissions reporting, particularly for large manufacturing sites.
• The Act on the Promotion of Sorted Collection and Recycling of Containers and Packaging obliges producers to recycle packaging waste, which applies to many consumer health products.

Voluntary and Market-Based Expectations

The Corporate Governance Code, a set of principles and guidelines for corporate governance of listed companies in Japan jointly established by the Financial Services Agency and the Tokyo Stock Exchange, encourages listed companies to disclose environmental and social initiatives, including climate change mitigation and sustainable supply chain management.

Voluntary standards, such as ISO 14001 for environmental management systems and the Task Force on Climate Related Financial Disclosures (TCFD)-aligned sustainability reporting, are widely adopted, especially by export-oriented or listed firms.

Sector-Specific Application

Medical device manufacturers must manage hazardous waste, ensure chemical safety, and consider sustainability in design and packaging.

Consumer health product manufacturers face packaging and recycling obligations and often adopt broader CSR measures to meet stakeholder expectations.

Advertising of pharmaceuticals, quasi-pharmaceuticals, cosmetics, medical devices and regenerative medicine products (“Pharmaceuticals, etc”) is subject to regulations under the PMD Act in addition to general advertising regulations under the Act Against Unjustifiable Premiums and Misleading Representations. The restrictions under the PMD Act are:

• prohibition on advertising, describing or circulating of false or exaggerated statements;
• restrictions on advertising of pharmaceuticals or regenerative medicine products for special diseases specified by the Cabinet Order (ie, cancer, sarcoma and leukaemia) to the public; and
• prohibition on advertising of:
1. unapproved pharmaceuticals, medical devices, or regenerative medicine products for which approval is required for sale; or
2. unapproved use of those approved.

The restriction at bullet point one indicates that the acts subject to the restrictions are not only literally “advertising” but also “describing” and “circulating” (collectively referred to as “Advertising”). In this regard, the Supreme Court has held (i) that the language “advertisements, descriptions and circulations” should be construed as the act of informing unspecified or many persons of the matters prohibited under Article 66, paragraph 1 of the PMD Act as a means of promoting the purchase or prescription of certain Pharmaceuticals, etc; and (ii) that whether or not such an act of informing can be regarded as a means of promoting the purchase or prescription of certain Pharmaceuticals, etc should be determined objectively in light of the content, nature, and mode of such act of informing (Supreme Court, 28 June 2021; Keishu, Vol 75, No 7, p 666). 

Based on the restrictions on Advertising under the PMD Act, a Code of Fair Practices in the Advertising of Pharmaceuticals, etc (the “Code”) was set by the MHLW (Revision of the Code of Fair Practices in the Advertising of Pharmaceuticals, etc (29 September 2017), Annex)). The Code specifies the criteria to be satisfied in order to ensure fair practice in Advertising of Pharmaceuticals, etc. The Code provides that, for example, claims to efficacy of Pharmaceuticals, etc requiring approval or certification for sale shall not, explicitly or implicitly, exceed the approved or certified scope and advertising of prescription pharmaceuticals directly to the public is prohibited, which is beyond the scope of the prohibition by Article 67 of the PMD Act.

With respect to unsubstantiated or misleading environmental claims in relation to medical device and consumer health products, there is no legislation and/or guidance that directly addresses them. However, misleading advertising to consumers may constitute a violation of the Act Against Unjustifiable Premiums and Misleading Representations.

As described in 1. Applicable Product Safety Regulatory Regimes, the PMD Act requires that, when marketing Pharmaceuticals, etc, a business operator is required to obtain a business licence from the Authorities and be authorised as an MAH for each Pharmaceuticals, etc. With respect to cosmetics, notification is sufficient if all ingredients therein are listed in their packages. Under the PMD Act, “manufacturing and sales” is defined as selling, lending or granting medical devices manufactured by oneself (including those manufactured by its subcontractor) or imported, or providing medical device programs via telecommunications lines. An MAH bears sole responsibility for the Pharmaceuticals, etc under the PMD Act.

The requirements for obtaining the business licence described are:

• the quality control method must conform to the GQP Ordinance for pharmaceuticals, quasi-pharmaceutical products and cosmetics, or the QMS Ordinance for medical devices;
• the post-marketing safety control method must conform to the GVP Ordinance; and
• the applicant must not fall under any of the disqualifying circumstances.

As described in 1.1 Medical Devices, the PMD Act classifies medical devices into General Medical Devices, Controlled Medical Devices and Highly Controlled Medical Devices, based on the risk level. This classification corresponds to the four risk-based categories of the GHTF (Global Harmonisation Task Force) classification (Classes I to IV), in which the two higher-risk categories are combined into a single category under the PMD Act.

As described above, for marketing medical devices, a business operator with the business licence must obtain an approval from the MHLW based on the PMDA’s scientific review. However, for medical devices with relatively low risk (GHTF Class II) for which the certification standard has been established, certification by a registered certification body (RCB) may suffice. For medical devices with extremely low risk (GHTF Class I), submitting notification to the PMDA may suffice.

The PMDA states its performance as being:

• world’s fastest review;
• gateway to regulatory approval in Asia; and
• internationally harmonised.

Fast and Predictable Review Process

The PMDA’s review period for a new drug (ie, the median of numbers of days from the filing date to the approval date) is 332 days (FY2023), which is the shortest among the EU, the USA, Canada, Switzerland, Australia and Japan, providing a clear timeline for market entry.

Various accelerated review schemes are available.

• Expedited Review – Designated by the MHLW. Pre-evaluated publicly known application items are automatically designated.
• Priority Review – Recognised as being highly useful in the treatment of serious diseases. Orphan drugs are automatically designated. Target review period is nine months.
• SAKIGAKE (Forerunner designation) – Priority consultation, priority review (six months), etc. Required to meet all four criteria:
1. innovative;
2. serious indication;
3. prominent efficacy; and
4. develop and NDA submission in Japan first in the world.
• Conditional Early Approval (for pharmaceuticals and medical devices) –
1. required to meet all four criteria including seriousness of indication, medical usefulness and a certain degree of efficacy and safety; and
2. early application without confirmatory clinical trials, on the condition that the safety and efficacy be further evaluated.
• Conditional and Time-Limited Approval (for regenerative medical products) –
1. required to meet all three criteria including heterogeneity, presumption to have the efficacy or performance claimed, and medical usefulness; and
2. early approval for a maximum of seven years, on the condition that the sales are limited to specialised physicians and medical institutions, and the safety and efficacy be further evaluated.

Utilisation of R&D Data for Abbreviated Review in Other Countries

Many countries in Asia have abbreviated review systems or the like, which allows them to use R&D data conducted in Japan as a reference. The PMDA will support regulatory authorities in such countries through providing the PMDA’s review reports and responding to their queries.

International Harmonisation

The PMDA joins the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), ICMRA (International Coalition of Medicines Regulatory Authorities), MDSAP (Medical Device Single Audit Program), etc leading international harmonisation in regulation.

In respect of a written new drug application, the MHLW issued a notification as of 6 September 2024 that foreign companies without a Japanese subsidiary or office in Japan at the time of submitting an application would be permitted to submit all the contents of the CTD, including the written new drug application and attachments thereto, in English; this procedure will be reviewed and may be expanded to other companies in the future.

GVP Ordinance

The MAH is required to take safety management measures such as the collection, evaluation, review of information on the use of products, and the implementation of safety assurance measures based on such review results in accordance with the GVP Ordinance.

Adverse Event Report System

The MAH is required to report to the MHLW through the PMDA in cases where it learns of the occurrence of adverse events and infections that cannot be clearly ruled out as having a causal relationship with the efficacy or safety of medical products. The reporting deadline is determined based on multiple factors such as severity: within 15/30 days; annual reporting (every year from the date of approval); or no reporting is required.

Recall (Self-Recall)

The MAH is required to take necessary measures, such as disposal, recall, suspension of sales, provision of information, or other appropriate actions, to prevent the occurrence or spread of health hazards resulting from the use of its products, if they become aware of such risks.

Re-Examination System/Re-Evaluation System

New drugs are subject to re-examination after a certain period following receiving approval. During the re-examination, the MAH reviews documents prepared in accordance with the GPSP Ordinance to assess whether the approved efficacy and safety of the product are maintained, whether there are any serious adverse effects that outweigh the approved efficacy and safety, etc. The re-evaluation system is designed to re-evaluate the usefulness of drugs that have been used for a long time in light of current scientific knowledge, which has been publicly announced by the Minister of Health, Labour and Welfare (“the HLW Minister”), after hearing of the opinion of the Pharmaceutical Affairs Council.

Use-Results Surveys

The MAH for certain medical devices designated by the HLW Minister must conduct a use-result survey to ensure the safety and performance of the medical devices. Through the use-result survey, the effectiveness and safety of the medical devices are verified by the PMDA at intervals determined according to the characteristics of each medical device.

The MHLW holds jurisdiction over the PMD Act, and the Pharmaceutical Safety Bureau of the MHLW, whose name was renewed along with reorganisation of the Pharmaceutical Safety and Environmental Health Bureau in 2023, undertakes the main duties and functions of the MHLW in respect of pharmaceutical affairs:

• clinical studies;
• approval reviews;
• safety measures; and
• compliance and narcotics, etc.

The PMDA is responsible for consultations concerning the clinical trials of new drugs and medical devices, approval reviews and surveys of the reliability of application data.

The HWL Minister delegates certain regulatory and supervisory responsibilities under the PMD Act to the heads of the local governments (prefectures, cities with public health centres, and Tokyo special wards) (ie, “Authorities” as defined in 1.1 Medical Devices). Authorities are responsible for:

• inspection and monitoring to ensure compliance with the PMD Act and related regulations;
• issuing and renewing licences and registrations for marketing, manufacture and sale of Pharmaceuticals, etc within their jurisdictions; and
• taking enforcement actions (see 3.2 Regulatory Enforcement Mechanisms).

With respect to biocides, the Ministry of Agriculture, Forestry and Fisheries, the Ministry of Economy, Trade and Industry (METI), the Ministry of Environment, and CAA may be relevant depending on which laws and regulations shall apply, which corresponds to the exposure route and life cycle of biocides, etc.

With respect to gene-edited products, GMOs and nutrition supplements, the CAA may be more relevant than the MHLW since the administration function related to food hygiene standards was transferred from the MHLW to the CAA in April 2024 and the CAA has undertaken responsibility for regulatory affairs related to biotechnology applied food (gene-edited products, GMOs), nutrition supplements and foods described in 1.2 Healthcare Products, including Nutrient Function Foods, FFC and FOSHU.

The MHWL and the delegated Authorities have monitoring and guidance powers under the PMD Act. The objectives of enforcement of the powers are:

• to confirm compliance with obligations associated with the licenses, etc.; and
• to detect and eliminate defective or non-compliant products, scheduled drugs and hazardous drugs.

Monitoring and guidance powers are enforced in accordance with the Guidelines of Pharmaceuticals Affairs Monitoring and Guidance (the “Monitoring Guideline”) to ensure the unified operation and efficient implementation of pharmaceutical surveillance and guidance activities conducted by the Authorities.

According to the Monitoring Guideline, when detecting violation of the PMD Act or the relevant regulations, the Authorities may take any of the following actions.

• Conduct on-site inspections and collect statements of explanation or reports to verify compliance.
• Issue corrective guidance if the violation is minor and it is deemed that corrective guidance through an instruction letter, etc will do without taking adverse measures, in which case it is not necessary to require a report.
• Make an adverse determination when deemed necessary after taking into account the circumstances of the violation and the risk of harm to public health. The following measures may be taken:
1. cancel any licence, registration or accreditation/approval which the Authorities previously granted;
2. temporarily stop the business operations of the licence holder;
3. order replacement of certain key personnel relevant to the pharmaceutical business of the licence holder;
4. order improvement of manufacturing management methods;
5. order improvement of structural facilities; and
6. issue inspection orders, disposal orders, reporting orders.

The Authorities may, after considering the nature of the violation and the intent of the violator, and when deemed necessary, consult with the MHLW in advance and file a criminal complaint pursuant to the Code of Criminal Procedure.

In respect of the PMD Act, a wide range of product safety offences can be identified. The three most frequently detected offences are:

• manufacturing or marketing without licence or registration, etc;
• false or misleading advertising; and
• improper handling of products.

Product safety offences may result in administrative sanctions, including administrative monetary penalties, or criminal penalties. Administrative monetary penalty payment orders were introduced in 2021 as a measure to strengthen penalties against a background that there had been a significant increase in violations from false or exaggerated advertising, particularly in internet advertising.

The penalty is calculated as 4.5% of the sales value of the relevant products during the period in which the violation (false or exaggerated advertising, etc) occurred. The period is from the date the violation began until a maximum of three years thereafter.

There are the following exceptions:

• if the penalty is less than JPY2.25 million (ie, sales of the subject products amount to JPY50 million or less), the penalty payment order does not apply; and
• if the violator voluntarily reports the subject conduct prior to detection of the offence by the Authorities, the penalty is reduced by 50%.

In serious cases, criminal penalties such as imprisonment or criminal fines may be imposed.

Any natural person who violates the PMD Act may be subject to criminal imprisonment and/or a criminal fine, and any legal entity (eg, a corporation) for whom or for whose benefit that natural person committed the violation, will be liable to a criminal fine. Manufacturing or marketing without a licence may be subject to imprisonment for up to three years, a fine of up to JPY3 million, or both. False or exaggerated advertising may be subject to imprisonment for up to two years, a fine of up to JPY2 million, or both.

In a recent case of the application of administrative sanctions, the MHLW announced on its website on 8 November 2024 that it had issued an improvement order to a Japanese subsidiary of an international medical device maker for the failure to report adverse events related to foreign medical devices subject to reporting obligations for adverse events within the specified timeframe.

In Japan, product liability claims can be brought under three main legal bases: the Product Liability Act, tort and contract.

Product Liability Act (PLA)

The PLA, effective since 1 July 1995, introduced strict liability for manufacturers, meaning they can be held liable for damages caused by product defects without the need for plaintiffs to prove negligence or intent. This act applies to any “movable” manufactured or processed goods, excluding real estate, unprocessed agricultural products, electricity, and standalone software. However, products incorporating software are covered.

A “defect” under the PLA is defined as a lack of safety the product should normally have, considering its characteristics, foreseeable use, and the state of knowledge at the time of delivery. This can include manufacturing defects, design defects, and instruction or warning defects. The PLA’s definition of “manufacturer” is broad, encompassing not only the actual producer but also importers, distributors, and anyone presenting themselves as the manufacturer.

Tort

In addition to the PLA, the Civil Code remains relevant, particularly for tort and contract claims. Under Article 709 of the Civil Code, a person who intentionally or negligently infringes another’s rights is liable for damages. This requires proving the defendant’s fault, which is a higher burden of proof compared to that under the PLA. This option is useful if a PLA claim fails or is time-barred.

Contractual Liability

If a defective product is supplied under a contract, the buyer can seek remedies for non-performance or either breach of contract or breach of implied statutory warranties under the Civil Code. Remedies include repairs, delivery of a substitute, price reduction, or compensation for damages. However, this is limited by the privity of contract doctrine, which generally restricts claims to the immediate parties of the contract, making it difficult for end-users to sue manufacturers directly.

Technological Advancements and Product Liability

Technological advancements, especially in AI-powered SaMD, complicate product liability. The “black box” nature of AI makes defect and causation determination challenging, increasing the plaintiff’s evidentiary burden and potentially diminishing the PLA’s strict liability intent. It is hard to ascertain if the defect is in the initial design, the training data, the algorithm’s learning process or external factors. Although a defect should exist at the “time of delivery” under the PLA, AI systems’ continuous learning capabilities challenge this assessment, necessitating continuous monitoring and updates.

How legislators are responding to such technological advancements

There is ongoing debate and research within government committees and expert groups regarding how to attribute liability for autonomous AI systems, especially those where human intervention is minimal. While no specific cross-sectional legislation on AI liability exists, discussions continue on how to allocate responsibility within complex AI supply chains, establish an appropriate liability regime for cases where defects in the continuous updates expected of AI result in damages, and potentially ease the burden of proof for victims.

Japanese courts determine jurisdiction for product liability claims based on the nature of the claim, whether it arises from tort, the PLA, or contract law.

Tort

Japanese courts have jurisdiction if the wrongful act or its consequences occurred within Japan. An exception exists if the consequences of a wrongful act committed abroad occur in Japan, but such consequences were not predictable.

Product Liability Act

Similar to tort claims, jurisdiction is established if the wrongful act or its consequences occurred in Japan. For PLA cases, “place of wrongful act” is interpreted as the place of manufacture. This interpretation allows Japanese courts to assert jurisdiction over domestic manufacturers even if the product causes harm exclusively abroad, broadening Japan’s reach in international product liability disputes. This covers both inbound (foreign product, local harm/consequences) and outbound (local product, foreign harm/consequences) scenarios, which is crucial for global manufacturers.

Contract Law

Jurisdiction is based on the place of performance of the contract within Japan or if the place of performance is determined to be within Japan according to the law selected under the contract. For contracts between consumers and enterprises, Japanese courts have jurisdiction if the consumer is domiciled in Japan at the time of the action or when the contract was concluded.

Jurisdiction Over Defendants

General jurisdiction over a defendant is typically established if the corporation’s principal office or business office is in Japan. Jurisdiction can also be asserted if the corporation’s representative or person in charge of its business is domiciled in Japan, especially if the corporation lacks an office in Japan or its location is unknown.

For international cases, Japanese courts require a jurisdictional basis under the venue rules of the Code of Civil Procedure and the absence of “exceptional circumstances” that would compromise fairness and prompt proceedings. This requirement helps foreign defendants argue against jurisdiction based on fairness and judicial economy, such as the burden of litigating in Japan and the location of crucial evidence.

Court Costs

The losing party is generally ordered to bear court costs, which typically include:

• filing fees – paid upfront by the plaintiff, calculated based on the amount of the claim sought;
• minor expenses – such as travel expenses and daily allowances for witnesses;
• expert’s fees – costs associated with expert testimony (if appointed by the court); and
• costs for document preparation, translation and submission.

Attorney’s Fees

In principle, each party is responsible for their own legal fees, regardless of the outcome of the lawsuit. However, in tort cases (including product liability claims brought under the PLA), Japanese courts may award a portion of the prevailing party’s attorney’s fees as part of the damages, typically limited to around 10% of the total damages awarded. For product liability claims based on contract law, this exception for attorney’s fees generally does not apply.

Measures to Protect Against Cost Orders

In Japan, while the specific “without prejudice” rule and formal “lodgement” seen in common law jurisdictions are not explicitly codified, the spirit of settlement discussions functions similarly. Parties can freely make settlement offers, and if an agreement is reached, it typically addresses outstanding costs or payments, negating the need for a court cost order. The Japanese legal system prioritises settlement, with courts often recommending or directing parties to engage in settlement discussions. These discussions, aimed at genuine settlement, generally will not prejudice a party’s substantive case in court.

In Japan, beyond private civil litigation, several public law mechanisms and administrative processes address contentious product-related matters, especially concerning safety. These mechanisms ensure public safety, enforce regulations, and can sometimes run in parallel with or even influence civil claims.

Regulatory Oversight and Enforcement

PMD Act

The PMD Act governs medical devices and pharmaceuticals, requiring pre-market approval, compliance with manufacturing standards, post-market surveillance, and reporting of adverse events. Violations can lead to:

• improvement orders;
• business suspension;
• recalls;
• licence revocation;
• fines; and
• criminal penalties.

Consumer Product Safety Act

The Consumer Product Safety Act covers consumer products, mandating accident reporting, recall orders and third-party conformity assessments for high-risk products.

Product Recalls

Voluntary recalls

Companies often initiate voluntary recalls upon discovering a defect or safety issue, typically in consultation with the PMDA/MHLW or METI. This is often done to mitigate potential liability and maintain public trust.

Mandatory recall orders

If a company fails to take appropriate action, the relevant ministry (MHLW for medical devices, METI for consumer products) can issue a mandatory recall order.

Information Dissemination

Agencies like the PMDA and the CAA maintain public databases and issue alerts (eg, “Yellow Letter” or “Blue Letter” from PMDA) to inform healthcare professionals and the public about recalled products and safety risks.

Public Inquiries and Investigations

PMDA investigations

The PMDA regularly conducts investigations into reported adverse events or suspected defects, collecting data, analysing root causes, and assessing risks. These investigations inform regulatory decisions, including recalls or revisions to product information.

CAA investigations

The CAA investigates consumer product accidents. They collect information through their “Consumer Accident Information Databank” and conduct their own analyses.

Special committees/expert panels

For particularly complex or high-profile incidents involving medical devices or other products, the MHLW or other ministries may establish special committees or expert panels to conduct in-depth inquiries, provide recommendations, and formulate new guidelines or policies.

In Japan, the concept of “class actions” or “representative actions” for product liability claims, particularly those involving personal injury from medical devices or health care products, differs significantly from the models seen in common law jurisdictions like the United States. However, Japan has developed mechanisms for collective redress, particularly for consumer protection.

Appointed Party System

If multiple individuals have common interests in a lawsuit, they can appoint one or more individuals from among themselves as “appointed parties” to represent them in court. The appointed party can pursue the case on behalf of the appointing parties, and the judgment will be binding upon them. The drawback is that each individual must formally appoint the representative, which can be cumbersome.

Act on Special Measures Concerning Civil Court Proceedings for the Collective Redress for Property Damage Incurred by Consumers

This Act allows Specified Qualified Consumer Organisations (SQCOs) to file lawsuits for collective redress for property damage under consumer contracts incurred by a considerable number of consumers. However, this mechanism does not cover claims for personal injury damages, lost profits, and pain and suffering, making it generally inapplicable to product liability claims for medical devices or healthcare products, which typically involve personal injury.

Lawsuits by Multiple Plaintiffs (Co-Ordinated Proceedings)

Despite the absence of broad class action legislation, Japanese law does permit lawsuits filed by multiple plaintiffs. When a significant number of victims are affected by a common issue, such as a defective medical device, lawyers can organise a team to gather potential plaintiffs. These individuals can join together as co-litigants in a single lawsuit under the general Code of Civil Procedure. This allows for a form of “group action” or “co-ordinated proceeding”, where numerous individual claims are litigated together.

In Japan, several bespoke Alternative Dispute Resolution (ADR) mechanisms exist to either avoid or complement traditional court proceedings, particularly for product liability claims involving medical devices or pharmaceuticals. These mechanisms are designed to offer more efficient and less adversarial avenues for dispute resolution and victim compensation.

Civil Mediation

Available through the courts, civil mediation allows parties to resolve disputes with the assistance of a mediator. This voluntary process aims to help parties reach a settlement without the need for a full trial and can be used for various civil claims, including product liability.

PL Centre

The Pharmaceutical Product Liability (PL) Centre of the Federation of Pharmaceutical Manufacturers’ Association of Japan handles complaints and disputes between consumers and pharmaceutical manufacturers. It offers mediation and consultation services to facilitate amicable settlements without litigation. The centre communicates with manufacturers on behalf of consumers and can escalate unresolved cases to arbitration through a committee of legal and medical experts, ensuring consumer protection and providing a structured approach to resolving disputes related to pharmaceuticals.

Medical ADR

The Japan Federation of Bar Associations and regional bar associations offer specialised ADR services for medical disputes. These services involve mediation and arbitration conducted by lawyers experienced in medical disputes, focusing on resolving disputes efficiently and fairly, considering the complexities of medical issues. Bar associations provide a structured environment for both parties to discuss and settle disputes, often involving third-party medical opinions to ensure a balanced resolution.

PMDA Compensation Scheme

The PMDA operates the Adverse Drug Reaction Relief System, an industry-funded, state-supported no-fault compensation scheme. This system provides compensation and relief to individuals who suffer health damage due to adverse reactions from appropriately used prescribed and purchased drugs.

In Japan, the relationship between product safety compliance and product liability claims is nuanced.

Compliance as a Factor, Not a Shield

Conformity or non-conformity with voluntary or mandatory safety regulations is generally considered only one factor to be taken into account when determining whether a product is defective in a product liability case.

Crucially, regulatory approval or compliance with manufacturing requirements does not automatically exempt a manufacturer from liability. Even if a medical device has received all necessary approvals and was manufactured in compliance with regulations, it can still be found defective in a civil claim if it lacks the safety it should ordinarily possess and causes harm.

Non-Compliance as Evidence of Defect or Negligence

Conversely, non-compliance with manufacturing requirements or a lack of appropriate warnings can be used as evidence to establish negligence or a product defect.

Civil Code claims

For tort claims under Article 709, plaintiffs must prove the defendant’s intent or negligence. Non-compliance with safety regulations is relevant evidence.

PLA claims

Under the PLA, strict liability applies. Plaintiffs need only prove a defect and causal link to the injury, not negligence. Compliance might offer a defence against negligence but not against a finding that a product is defective. The “state of the art” defence allows manufacturers to argue non-liability if defects were undetectable given the scientific knowledge at the time of delivery.

The PMD Act was amended in May 2025, with phased implementation scheduled to occur over the following three years. While the majority of the amendments concerning product safety and accountability pertain to pharmaceuticals and the pharmacy system, certain provisions are also applicable to medical devices.

The most notable amendment for MAHs and manufacturers of medical devices, pharmaceuticals, cosmetics and regenerative medicine products concerns Sekinin Yakuin – board members responsible for quality and safety. The amended Act authorises the HLW Minister to order their replacement if it is determined that improvement necessary to prevent public health risks cannot reasonably be expected without such a change.

From the perspective of consumer access, another noteworthy amendment aims to address emerging challenges such as increased medical demand due to the ageing population, and the declining number of healthcare professionals – especially the urban concentration of pharmacists. The amendment allows for the sale of over-the-counter (OTC) drugs under the remote supervision of pharmacists and permits partial outsourcing of dispensing operations at pharmacies.

In response to the growing social issue of OTC drug abuse, particularly among younger individuals, the amendment also strengthens regulations on designated drugs that present a risk of misuse. For such products, the MHLW has introduced mandatory labelling requirements on primary packaging, prohibited the sale of large-volume packages and multiple units to young people, and imposed requirements that even small-volume products be sold either face-to-face or via online platforms. Furthermore, these products must be displayed in pharmacies in a manner that facilitates proper use.

Japan has taken environmental issues seriously for more than 50 years, and that commitment remains unchanged. The Ministry of Environment has issued the Environmental Labelling Guidelines since 2009. The guidelines were revised in March 2025 and require that self-declared environmental claims comply with Type II environmental labelling under ISO 14021. However, non-compliance does not immediately result in the imposition of penalties.

The recent amendment to the PMD Act introduces a new framework to address ongoing prescription drug shortages, especially generics, caused by quality management issues. Under the revised law, an MAH must appoint a Supply Chain Management Officer responsible for creating supply plans, monitoring supply status, and co-ordinating with manufacturers, wholesalers and other stakeholders. This officer oversees the entire drug supply system. Similar to the Sekinin Yakuin system, the MHLW can order the replacement of the Supply Chain Management Officer if deemed necessary to ensure effective supply management. This amendment will come into effect within two years of the amendment.

In connection with the above, an amendment to the Medical Care Act is currently under deliberation in the Japanese Diet to address ongoing drug supply issues. The proposed revision would require MAHs and manufacturers of designated pharmaceuticals to take preventive or production-boosting measures against supply shortages, following new guidelines to be issued by the HLW Minister.

Under the proposed system, the HLW Minister must establish Guidelines on Ensuring Stable Supply, targeting pharmaceuticals and essential raw materials or components. Among these, certain products may be further designated as Critical Supply Pharmaceuticals if, after consultation with the Health Sciences Council, the HLW Minister reasonably determines that a shortage is likely and could seriously impact public health.

In such cases, MAHs or manufacturers will be instructed to submit a Supply Shortage Prevention Plan. If the risk is particularly high, a Production or Importation Plan may also be required. Compliance with these plans will be mandatory, and failure to comply may result in public disclosure by the HLW Minister. The government, in turn, is expected to support affected companies through financial or other assistance measures.

AI is now embedded in diverse functions across the healthcare industry, from administrative support to data analysis and patent drafting. While its impact is broad, its application diverges in pharmaceuticals and medical devices.

In drug development, AI serves as a tool for compound design, pharmacological prediction, and digital simulation of clinical trials, etc. Several pharmaceutical companies have reported advancing AI-assisted candidates into clinical testing.

Meanwhile, in the medical device domain, AI often constitutes the product itself – as seen in SaMD. In Japan, nearly 100 AI-powered SaMDs have received PMDA approval and insurance coverage. Data privacy reforms have facilitated academia-industry collaboration, especially in AI-based diagnostic tools used with endoscopic technologies, where Japan maintains global leadership.

In June 2025, Japan enacted a new AI law aimed at promoting innovation while managing risks. The Act established a national AI Strategy Headquarters and mandates the creation of a Basic AI Plan. Unlike the EU AI Act, Japan’s legislation imposes no penalties and only light obligations on AI developers, though future amendments are anticipated.

Further legal reforms are underway, including proposals to recognise AI developers as co-inventors in patent applications. Provisions addressing generative AI are being integrated into existing legal frameworks.

The PMDA’s IDATEN framework allows for pre-approved post-marketing modifications to medical devices, such as software updates, with simplified notification procedures. However, for AI-powered SaMDs, challenges like domain shift may require more dynamic regulatory responses, and excessive retraining risks overfitting.

Adaptive AI – systems that autonomously enhance performance – offers great promise but remains unapproved worldwide. Nonetheless, the PMDA has shown willingness to review such SaMDs, especially when applicants can demonstrate the legitimacy of autonomous updates through scientifically robust methods, including the use of explainable AI.