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The legal framework for drugs and medical devices in Shizuoka is governed primarily by national law, applied and enforced locally by prefectural authorities. The central rules are set out in the Pharmaceuticals and Medical Devices Act - commonly called the PMD Act - and are implemented by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. In practice, manufacturers, importers, distributors, pharmacies, medical institutions and clinical researchers in Shizuoka also work with the Shizuoka Prefectural Government and local public health centers for licensing, inspections and enforcement. The system covers pre-market approval, product classification, manufacturing and marketing authorization, labeling, advertising controls, post-market surveillance, adverse-event reporting, and recall procedures.
Regulatory matters for drugs and medical devices are technical and compliance-sensitive. A lawyer with experience in Japanese pharmaceutical and medical-device regulation can help you in a range of situations:
- Market entry and product registration: understanding classification, approval pathways, and submission requirements under the PMD Act.
- Licensing and permits: obtaining or defending manufacturing, import, wholesale distribution or pharmacy licenses issued at the prefectural level.
- Advertising and labeling disputes: ensuring claims and promotional materials comply with strict advertising rules and the Act against Unjustifiable Premiums and Misleading Representations.
- Post-market issues: responding to adverse-event reports, leading or advising on recalls, and managing communications with regulators.
- Clinical trials and research: drafting informed-consent forms, compliant trial protocols, and navigating institutional review boards and reporting obligations.
- Product liability and compensation claims: defending or pursuing civil claims when injury or loss is alleged from a drug or device.
- Criminal exposure and enforcement actions: representing clients in inspections, administrative penalties, and criminal prosecutions for violations of the PMD Act or controlled-substances laws.
- Cross-border issues: handling import-export compliance, customs, and coordination with foreign manufacturers or distributors.
Key aspects of the local legal environment in Shizuoka that are particularly relevant include:
- Prefectural licensing and oversight - Many operational licenses for manufacturing, wholesale distribution and pharmacies are issued or inspected by Shizuoka Prefectural Government offices or local public health centers. Procedures, required documentation and inspection timing may vary locally while remaining grounded in national law.
- Enforcement and inspections - Local authorities carry out facility inspections, sample testing and enforcement actions. They coordinate with national agencies for major safety issues or complex investigations.
- Post-market surveillance and reporting - Firms must report adverse events and quality defects promptly to the PMDA and to local public health centers as required. Local authorities may order recalls or corrective actions within the prefecture.
- Controlled substances and narcotics - Regulations on narcotics, stimulants and psychotropic substances are strictly enforced. Local police, customs and public health agencies cooperate to regulate handling, storage and prescription control.
- Clinical trials and institutional approvals - Hospitals and research institutions in Shizuoka follow national clinical trial standards, but local ethics committee (institutional review board) approvals and reporting are required for trials conducted in the prefecture.
- Advertising and consumer protection - Local consumer affairs offices and prefectural authorities may act against misleading medical claims or unfair practices in cooperation with national agencies.
- Coordination with healthcare systems - Local rules interact with national reimbursement, pricing and hospital regulations. If reimbursement or listing is relevant, national procedures will dominate, but local hospital procurement practices matter for market access.
Products are classified based on intended use, risk level and technical characteristics. Medical devices fall into classes I to IV, with higher classes subject to stronger review. The classification determines the approval pathway, required documentation and inspection level under the PMD Act.
Yes. Manufacturing, wholesale distribution and pharmacy operations generally require prefectural licenses in addition to national approvals for specific products. Foreign manufacturers often work with a local marketing authorization holder or importer licensed in Japan.
Timelines vary by product class, data completeness and whether the application follows standard or expedited routes. Simple cases can take months, while complex high-risk devices or novel drugs can take a year or more. Pre-submission consultations with the PMDA and local authorities can clarify expectations.
Immediately follow your internal safety procedures, preserve records and samples, and report the event to the PMDA and the appropriate local public health center according to reporting timelines. Notify legal counsel early to manage regulator communications and potential civil exposure.
Off-label use by physicians is permitted in clinical judgment, but manufacturers cannot promote off-label uses. Off-label use may raise increased liability and reporting obligations if adverse events occur, so institutional review and clear documentation are important.
Violations of the PMD Act can lead to administrative orders, suspension or revocation of licenses, product recalls, fines and criminal penalties in serious cases. Civil liability and compensation claims may also arise if patients are harmed.
Recalls are coordinated with national regulators, but local public health centers and the Shizuoka Prefectural Government will participate in execution and communication with healthcare providers and consumers within the prefecture. A lawyer can help manage notifications and regulatory reporting.
Clinical trials require institutional review board approval at the trial site and must comply with national laws and good clinical-practice standards. Trials involving drugs or devices may require notification to or approval from national authorities, and local site-specific requirements must be satisfied.
Customs can detain products that appear noncompliant with regulatory or import rules. You should engage legal counsel and the local importer or marketing authorization holder to clarify documentation, correct deficiencies and arrange testing or re-export if required.
Look for lawyers or firms experienced in regulatory compliance, product liability and healthcare law. Contact the Shizuoka Bar Association for referrals, ask about specific PMD Act and product experience, request case examples and confirm language capabilities if you are a non-Japanese speaker.
When seeking help or reliable information, consider these organizations and resources that are relevant in Japan and locally in Shizuoka:
- Ministry of Health, Labour and Welfare - sets national policy and law for drugs and devices.
- Pharmaceuticals and Medical Devices Agency - technical review, approval support and safety monitoring at the national level.
- Shizuoka Prefectural Government - Health and Welfare Department and local public health centers for prefectural licensing, inspections and local guidance.
- Shizuoka Bar Association - for lawyer referrals and finding counsel with local expertise.
- Japan Consumer Affairs Agency and local consumer centers - for consumer complaints and safety information.
- Industry associations such as national pharmaceutical and medical-device associations - for practical compliance guidance and industry standards.
- Local hospitals, institutional review boards and university research offices - for clinical trial procedures and site-specific requirements.
- Japan External Trade Organization or other business-support bodies - for foreign companies seeking market entry assistance and general regulatory orientation.
If you need legal assistance with drugs or medical devices in Shizuoka, these practical next steps will help you proceed efficiently:
- Gather documentation - collect product specifications, regulatory correspondence, quality records, lab results, contracts and any incident reports before your first meeting with counsel.
- Identify relevant expertise - seek a lawyer with specific experience in PMD Act matters, product liability and prefectural licensing, and confirm whether you need bilingual support.
- Contact local authorities for basic guidance - the Shizuoka Prefectural Government or local public health center can explain local licensing procedures and required forms.
- Arrange an initial consultation - use this to ask about process, fees, estimated timelines and strategy, and to assess whether the lawyer has the right technical and regulatory experience.
- Preserve evidence and communications - keep careful records of complaints, communications, distribution lists and quality control steps to support any regulatory response or litigation defense.
- Plan for regulatory and public communications - coordinate legal, regulatory and public-relations input early if a safety issue or public concern arises.
- Consider preventive steps - regular compliance audits, staff training, and pre-submission meetings with PMDA or local authorities can reduce risk and speed approval or response times.
Legal issues in the drugs and medical-device area can be complex and time-sensitive. Engage qualified counsel promptly to protect public safety, meet regulatory obligations and manage legal risks effectively in Shizuoka.
