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When people refer to "FDA Law" in Japan they are usually thinking about the regulatory framework that governs pharmaceuticals, medical devices, cosmetics, regenerative medicine, and related products. The United States uses the term FDA - the Food and Drug Administration - but in Japan the equivalent roles are carried out by the Ministry of Health, Labour and Welfare - MHLW - and the Pharmaceuticals and Medical Devices Agency - PMDA. Together they enforce the Pharmaceuticals and Medical Devices Act and related laws that set rules for product approval, manufacturing quality, clinical trials, labeling, advertising, import and export, post-market surveillance, and recalls. If you operate, develop, import, or distribute health-related products in Akishima, you must follow these national rules and the local administrative procedures that apply in Tokyo Metropolis and Akishima City.
Regulatory law for medicines and medical devices is complex and technical. A lawyer with experience in Japanese pharmaceutical and medical-device regulation can help in many common situations, including:
- Product classification and regulatory pathway selection - determining whether a product is a drug, medical device, quasi-drug, cosmetic, or another category and which rules apply.
- Marketing authorization and registration - preparing applications for approval, communicating with PMDA and MHLW, and responding to requests for additional information.
- Clinical trials and human-subjects compliance - advising on informed consent, certified review boards, trial registration, good clinical practice, and data-handling requirements.
- Manufacturing and quality compliance - interpreting good manufacturing practice requirements, audits, remediation plans, and interactions with inspectors.
- Advertising, labeling, and promotion - ensuring claims comply with the law and avoiding misleading or unauthorized promotion.
- Imports, customs, and distribution - handling customs clearance, import permits, and distributor agreements.
- Post-market obligations - adverse-event reporting, corrective actions, recalls, product liability, and risk management plans.
- Enforcement and dispute resolution - representing clients in administrative investigations, negotiating settlements, defending against penalties, and pursuing or defending litigation.
- Corporate transactions and due diligence - regulatory due diligence in mergers, acquisitions, licensing, and joint ventures.
- Data protection and information transfer - ensuring compliance with personal data laws when handling clinical data, especially for cross-border transfers.
In Akishima you must comply first and foremost with national laws administered by MHLW and PMDA. Key legal instruments and local considerations include:
- Pharmaceuticals and Medical Devices Act - the central statute governing approval, manufacturing, labeling, advertising, and post-market requirements for drugs and medical devices. It sets the approval pathways, conformity assessment, certification systems, and penalties for non-compliance.
- Food Sanitation Act - applies where products cross into food, supplements, functional foods, or have effects on food safety.
- Act on the Protection of Personal Information - governs handling of personal and clinical trial data. This affects consent, anonymization, data sharing, and transfers outside Japan.
- Medical Care and Related Laws - rules affecting medical institutions, health care professionals, and clinical practice that can affect clinical trials and device use.
- Local administrative procedures - while approvals are national, local public health centers and Tokyo Metropolitan offices may be involved in business registration, facility inspections, and some permits. Akishima City may have local business licensing steps or environmental regulations for manufacturing facilities.
- Customs and import regulations - border controls and customs procedures for importing active pharmaceutical ingredients and finished products are enforced at the ports and by Tokyo regional customs offices.
- Standards and guidance - PMDA and MHLW publish technical guidance documents and notifications that describe regulatory expectations in detail. Staying current with guidance is critical because practice often follows guidance as much as statute.
- Enforcement and penalties - violations can result in administrative orders, product seizures, suspension of business operations, criminal penalties including fines and imprisonment for serious violations, and civil liability for harm caused by products.
Japan does not have an organization called FDA. The main regulatory authority for pharmaceuticals, medical devices, and related products is the Ministry of Health, Labour and Welfare - MHLW - supported by the Pharmaceuticals and Medical Devices Agency - PMDA - which handles technical reviews, inspections, and post-market surveillance.
Yes. Most medical devices require either marketing authorization from MHLW or certification by a registered certification body, depending on device classification and risk level. Lower risk devices may follow a certification route, while higher risk devices generally require premarket approval.
Timeframes vary widely. Drug approvals commonly take many months to years because of clinical data requirements and review complexity. Medical device reviews can be shorter for lower-risk devices but higher-risk devices require more extensive review. Preparation time for the application is also significant.
You can run a clinical trial in Akishima if you follow Japanese good clinical practice. You need approval from a certified review board, informed consent from participants, registration of the trial, and adherence to reporting rules. Depending on the trial, notifications or approvals from MHLW or PMDA may be required.
Manufacturers and marketing authorization holders must report serious adverse events and other specified incidents to PMDA and MHLW within prescribed timelines. Healthcare professionals also have reporting obligations. Post-market surveillance and timely reporting are critical to compliance.
Imports are governed by national customs rules and require proper documentation, permits, and compliance with quality and safety standards. Importers must ensure products meet Japanese regulatory requirements and be prepared for inspections and sample testing by authorities.
Non-compliance can lead to administrative actions such as warnings, suspension of sales, product recalls, fines, seizure of goods, and criminal prosecution in severe cases. Civil claims for damages and reputational harm can also follow regulatory breaches.
Complex regulatory representation before Japanese authorities and in court is typically handled by a Japanese licensed attorney - bengoshi. Foreign counsel can assist in international aspects and translation, but a bengoshi is required for formal legal representation in Japan and for court proceedings.
Costs depend on the scope - advice, application drafting, representation in negotiations, or litigation. Some lawyers charge hourly rates, others offer fixed-fee packages for specific tasks like filing an application or conducting a compliance audit. Ask for a fee estimate and scope before engagement.
Product classification is a technical regulatory determination that depends on intended use, claims, and design. Consult PMDA guidance, MHLW notifications, and seek advice from a regulatory lawyer or regulatory affairs specialist to ensure correct classification and pathway selection.
For authoritative information and assistance consider these national and local bodies and organizations - seek contact information through official channels or directories:
- Ministry of Health, Labour and Welfare - MHLW - the ministry responsible for healthcare regulation in Japan.
- Pharmaceuticals and Medical Devices Agency - PMDA - handles technical review, inspections, and post-market surveillance.
- Tokyo Metropolitan Government offices - for regional business registration, environmental and facility matters that affect manufacturers in Akishima.
- Akishima City Office and local public health center - for municipal-level business procedures and public health coordination.
- Regional customs offices - for import and export procedures and inspections.
- Japan Federation of Bar Associations and Tokyo Bar Association - for lawyer referral services and to verify lawyer qualifications.
- Industry associations - for example associations representing pharmaceutical and medical device manufacturers that provide guidance and support to members.
- Certified review boards and ethics committees - for clinical trial review and approvals in Japan.
If you need legal assistance with pharmaceutical or medical-device matters in Akishima, consider the following practical steps:
- Gather documents - collect product specifications, labeling, clinical data, manufacturing records, import documents, contracts, and any communications with regulators.
- Prepare a concise summary - write a one-page summary of the issue, objectives, and deadlines to share with potential counsel.
- Find the right specialist - look for a bengoshi with experience in life-sciences regulation, product approvals, and administrative proceedings. Ask for examples of similar work and references if appropriate.
- Ask about language and communication - confirm whether your lawyer or their team can work in English if needed, and how translations will be handled.
- Discuss fees and timeline - get a written engagement letter that outlines fees, billing arrangements, and an estimated timeline for key milestones.
- Preserve evidence and records - keep all records and communications organized and refrain from public statements that could affect regulatory or legal positions.
- Take urgent steps if needed - if you face an inspection, enforcement action, product complaint, or safety signal, contact counsel immediately to preserve rights and respond appropriately.
- Consider compliance improvements - even if there is no immediate problem, a regulatory audit or compliance program can reduce future risk and speed market access.
Working with experienced local counsel and regulatory specialists will help you understand applicable rules, reduce legal risk, and navigate the approval, market entry, and post-market obligations for health-related products in Akishima and across Japan.
