Existing user? Sign in
Share your needs with us, get contacted by law firms.
Free. Takes 2 min.
In Uruma, as across Japan, the sale, manufacturing, and use of pharmaceuticals and medical devices are tightly regulated to protect patient safety and public health. The primary framework is the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices and Equipment, commonly referred to as the PMD Act. This national law is administered by the Ministry of Health, Labour and Welfare (MHLW) and implemented in practice by the Pharmaceuticals and Medical Devices Agency (PMDA).
Local enforcement in Uruma is carried out through Okinawa Prefecture and the city’s health authorities, under the PMD Act. They handle licensing of pharmacies, distributors, medical facilities, and the registration and inspection of devices used or sold in the area. Practitioners and businesses must comply with national standards while coordinating with prefectural and city health departments for local requirements.
The PMD Act also governs post-market surveillance, adverse event reporting, recalls, and enforcement actions. Manufacturers and distributors must register devices and obtain appropriate approvals or clearances before market entry, with ongoing obligations after product launch. Recent updates have strengthened safety monitoring and traceability for higher-risk devices.
“The PMD Act provides a unified framework to ensure the quality, efficacy and safety of pharmaceuticals and medical devices in Japan.”
Sources: PMDA - PMD Act overview; MHLW - PMD Act guidance. See also the World Health Organization for international context on medical device safety and regulation.
PMDA English site | MHLW English site | WHO - Medical devices
The core legal framework governing drugs and medical devices in Uruma comes from national legislation, primarily the PMD Act. This Act classifies devices and medicines, requires pre-market approvals or notifications, and establishes post-market surveillance and recall authorities. Enforcement is carried out by national and prefectural bodies, with local implementation coordinated by Okinawa Prefecture and Uruma City health authorities.
Key regulatory concepts you should know include device classification, pre-market approval versus notification, post-market surveillance, adverse event reporting, recalls, and labeling requirements. The PMD Act also obligates manufacturers and distributors to maintain traceability and documentation for regulatory inspections.
Primary statute: Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices and Equipment (PMD Act). This is the central framework used by regulators when evaluating products offered in Uruma and Okinawa.
Related enforcement framework: Enforcement Regulation and ministerial notifications under the PMD Act, which provide the procedural rules for approvals, inspections, and recalls. These regulations guide how regulators enforce the PMD Act at the local level in Uruma.
Historical context: The PMD Act replaced earlier Pharmaceutical Affairs Law provisions and standardized rules for modern drug and device regulation in Japan. This transition aimed to strengthen safety controls across the supply chain in Uruma and nationwide.
Source notes: PMDA and MHLW guidance explain the PMD Act structure, device classification, and enforcement mechanics. For broader context on global regulatory practices, see WHO resources on medical devices.
PMDA English - PMD Act structure | MHLW English - Health regulatory framework | WHO - Medical devices regulation
The PMD Act is Japan’s main framework for drug and medical device safety. It requires pre-market approval or notification, post-market surveillance, and recalls. In Uruma, regulators enforce these rules through prefectural and city health authorities.
Manufacturers or distributors must submit device registration or pre-market approval documents to PMDA, with the MHLW oversight. Local steps in Uruma are coordinated through Okinawa Prefecture health departments.
Timelines vary by device class. Higher risk devices typically require more data and reviews, while Class I devices may involve notifications. Expect several months from submission to decision in many cases.
While not legally required, a local lawyer with PMD Act experience helps navigate filings, inspections, and potential penalties. Local counsel can liaise with prefectural authorities efficiently.
Adverse events should be reported to PMDA through the appropriate channels and/or the manufacturer. Your lawyer can assist with documentation and regulator communications.
Penalties include fines and possible criminal charges depending on the harm and intent. A lawyer can help assess liability and coordinate corrective actions with regulators.
Fines vary by violation type, severity, and scale. Corporate penalties can range from tens of thousands to millions of yen, plus potential business restrictions.
Yes. Medical devices and associated software may collect personal data, which must be protected under privacy laws and device-specific guidelines. Legal counsel can help ensure compliance.
Class I devices are low risk and often require notification; Class IV devices are high risk and require rigorous pre-market approval. The PMD Act assigns device classifications by risk.
Yes, you can appeal recall actions or negotiate with regulators through your attorney. A lawyer can help prepare defense, evidence, and corrective plans.
Prepare company licenses, device registrations, labeling proofs, distribution records, and post-market surveillance documents. A lawyer can help assemble a compliant package.
Not all devices require clinical trials; higher risk devices often need robust data. A regulatory attorney can determine the evidentiary requirements for your device.
Lawzana helps you find the best lawyers and law firms in Uruma through a curated and pre-screened list of qualified legal professionals. Our platform offers rankings and detailed profiles of attorneys and law firms, allowing you to compare based on practice areas, including Drugs & Medical Devices, experience, and client feedback.
Each profile includes a description of the firm's areas of practice, client reviews, team members and partners, year of establishment, spoken languages, office locations, contact information, social media presence, and any published articles or resources. Most firms on our platform speak English and are experienced in both local and international legal matters.
Get a quote from top-rated law firms in Uruma, Japan — quickly, securely, and without unnecessary hassle.
Disclaimer:
The information provided on this page is for general informational purposes only and does not constitute legal advice. While we strive to ensure the accuracy and relevance of the content, legal information may change over time, and interpretations of the law can vary. You should always consult with a qualified legal professional for advice specific to your situation.
We disclaim all liability for actions taken or not taken based on the content of this page. If you believe any information is incorrect or outdated, please contact us, and we will review and update it where appropriate.
