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Japan regulates drugs, medical devices, and related products under a national framework centered on the Pharmaceuticals and Medical Devices Act - often abbreviated as the PMD Act. Onojo, as a municipality in Fukuoka Prefecture, follows the national rules administered by the Ministry of Health, Labour and Welfare - MHLW - and the Pharmaceuticals and Medical Devices Agency - PMDA. Local public health offices and the Onojo city health center play supporting roles for administration, inspections, and community-level public health matters.
Under the PMD Act, products require appropriate approval, certification, or notification before they can be marketed. The law covers product safety, manufacturing and distribution standards, labeling and advertising restrictions, adverse event reporting, and post-market surveillance. Other relevant national laws include the Act on Product Liability, the Pharmacists Act, the Medical Practitioners Act, and narcotics and psychotropic substance control laws. Administrative sanctions and criminal penalties can apply for serious violations.
Legal help is often necessary because drug and device regulation is technical, fast-moving, and enforcement can involve civil, administrative, and criminal consequences. Typical situations where a lawyer is useful include:
- Market entry and product approval - ensuring registration, clinical data, and Japanese-language documentation meet PMD Act requirements.
- Licensing and compliance - complying with GMP, GCP, quality systems, and distributor or manufacturing licenses.
- Adverse events and recalls - handling regulatory notifications, product recalls, and risk communications while minimizing liability exposure.
- Product liability claims - defending or negotiating compensation for injury claims under the Act on Product Liability or civil negligence theories.
- Administrative enforcement - representing clients in hearings, responding to inspection findings, or negotiating corrective action with MHLW, PMDA, prefectural health authorities, or municipal offices.
- Criminal investigations - advising individuals or companies facing investigations for illegal importation, unapproved sale, or violations related to controlled substances.
- Contracts and commercial disputes - drafting distribution, licensing, manufacturing, or clinical trial agreements and resolving cross-border disputes.
Key legal points relevant to Onojo residents and businesses are driven by national law but applied locally:
- Approval and Certification - Drugs normally require marketing authorization from MHLW/PMDA. Medical devices are classified by risk - Class I, II, III, IV - with different approval or certification routes. Some Class II devices can be handled through certified bodies.
- Marketing Authorization Holder - Each product must have a responsible marketing authorization holder - the company or entity accountable for post-market obligations and reporting.
- Good Practices - Manufacturers and importers must follow Good Manufacturing Practice - GMP - for drugs and Good Quality Management Practice for devices. Clinical trials must comply with Good Clinical Practice - GCP.
- Post-market Safety - Companies must report adverse events, implement safety measures, and cooperate with PMDA safety reviews. Local health centers may assist in collecting reports at the municipal level.
- Labeling and Advertising - Labels, package inserts, and advertising must be in Japanese and must not make unauthorized claims. Misleading advertising or promotion of unapproved uses can lead to penalties.
- Professional Regulations - Pharmacists, medical practitioners, and retailers are subject to the Pharmacists Act and Medical Practitioners Act. Pharmacy licensing and operation rules are enforced locally.
- Controlled Substances - Narcotics, psychotropics, and certain precursor chemicals are tightly controlled by separate laws. Storage, prescription, and record keeping rules apply and violations carry heavy penalties.
- Product Liability and Consumer Protection - Injured parties can seek compensation under the Act on Product Liability and general tort law. The Consumer Affairs Agency and local consumer centers provide guidance on consumer claims and voluntary recalls.
If the product is intended to diagnose, treat, prevent, or alleviate human disease or to affect body structure or function, it is likely regulated. Classification determines the route - drugs need marketing authorization, devices are classified into risk classes with differing approval or certification requirements. Consult PMDA guidance or a regulatory lawyer to confirm.
Enforcement is primarily national - MHLW and PMDA - but local authorities such as Fukuoka Prefecture health officials and the Onojo city health center assist with inspections, reporting, and community-level enforcement. Serious administrative actions or prosecutions are handled by national bodies.
Immediately document the report, preserve product samples and records, and notify your marketing authorization holder or regulatory contact. Under PMD Act rules, certain adverse events must be reported to PMDA within specific timelines. Notify your local health center if appropriate and consult counsel for communication and liability management.
Yes, but importers must meet PMD Act requirements including appointing a Japanese marketing authorization holder or a responsible local representative, complying with labeling in Japanese, and ensuring the product has appropriate approval or certification. Working with a Japanese regulatory specialist is recommended.
Risks include administrative orders to stop sales, product seizure, fines, and criminal prosecution in severe cases. There is also civil liability for harm caused by the product and reputational damage. Advertising or making unapproved claims increases the risk of sanctions.
Recalls can be voluntary or ordered by authorities. Companies must notify authorities, consumers, and distributors, and take corrective measures. PMDA and MHLW oversee recall processes. Local consumer centers and health offices help manage community communications and logistics.
Injured patients can bring claims under the Act on Product Liability, alleging defectiveness without proving negligence in some cases, or under civil tort law for negligence. Criminal charges may also arise for gross misconduct. Compensation claims often involve medical records, expert testimony, and regulatory documents.
Yes. Prescription drugs and certain devices cannot be advertised to the general public for therapeutic claims. Over-the-counter products and quasi-drugs have stricter requirements on claims and labeling, and all advertising must be truthful and not misleading. Promotional activities to medical professionals must follow professional rules.
Involve a lawyer as early as possible if an inspection identifies potential noncompliance, before responding to enforcement notices, or when corrective actions could have legal consequences. A lawyer can help craft responses, protect privileged communications, and negotiate with authorities.
Look for legal specialists with experience in pharmaceutical and medical device regulation, administrative law, and product liability. Check bar association directories, ask for referrals from industry associations, or contact local business chambers. Consider bilingual counsel if you are a foreign company.
Use these types of organizations to get authoritative guidance and practical help:
- Ministry of Health, Labour and Welfare - national regulator for pharmaceuticals and devices.
- Pharmaceuticals and Medical Devices Agency - PMDA - responsible for scientific review, safety monitoring, and post-market surveillance.
- Fukuoka Prefecture Health Department and Onojo City Health Center - local public health offices that handle community-level issues and inspections.
- Consumer Affairs Agency - oversees consumer protection and coordinates recalls.
- Japan Pharmaceutical Manufacturers Associations and trade groups - for industry guidance and best practices.
- Local bar associations and law firms with regulatory practice - for legal representation and counsel.
- Clinical trial and quality standards guidance - for GCP, GMP, and quality system compliance resources available from MHLW and PMDA.
If you need legal assistance related to drugs or medical devices in Onojo, use this practical plan:
- Gather documentation - collect product specifications, approval or certification documents, labeling, clinical data, distribution contracts, inspection reports, and any adverse event records.
- Identify the issue - determine if the matter is regulatory compliance, a safety incident, a dispute, or potential criminal exposure.
- Contact local authorities for guidance - the Onojo city health center or Fukuoka Prefecture health department can provide initial procedural information.
- Consult a specialist lawyer - choose counsel experienced in PMD Act matters, regulatory response, and product liability. Prepare a concise brief of facts and the documents you gathered for your first meeting.
- Plan communications - coordinate any public or consumer statements through legal and regulatory advisers to reduce legal risk and meet reporting obligations.
- Consider timelines and costs - regulatory processes and litigation have strict deadlines and can be costly. Ask your lawyer about expected timelines, fee structures, and alternative dispute resolution options.
- Keep records and improve compliance - use the experience to strengthen quality systems, reporting processes, and staff training to reduce future risk.
Taking these steps will help protect public safety, comply with Japanese law, and address legal exposure efficiently. If you are unsure where to start, reach out to the Onojo city health center or a qualified regulatory lawyer to get specific advice tailored to your situation.
