REGULATORY INSIGHTS
Japan Medical Device Regulatory Insights
Practical articles and industry updates on Japan's medical device regulatory affairs, PMDA submissions, and market entry.
NEWS
Industry News
Global and Japan MedTech News | October 19–25, 2026
Primary-source updates on UK CE recognition, QIAGEN’s takeover agreement, US device decisions, and Japan’s reimbursement, funding and product plans.
Read moreGlobal MedTech News | PMDA GenAI Review, Peripheral EBUS & Surgical Robotics (Oct 12–18, 2026)
MedTech news Oct 12–18, 2026: PMDA GenAI review draft, FDA clearances, Olympus peripheral EBUS, U.S. device reimbursement and robotic surgery investment.
Read moreGlobal MedTech News | FDA Histotripsy Rules, MRI-to-3D AI & HOYA Divestiture (Oct 5–11, 2026)
Oct 5–11 MedTech news: FDA histotripsy and home-sampling rules, MRI-to-3D AI clearance, remote stroke robotics, Zenflow funding and HOYA divestiture.
Read moreGlobal MedTech News | FDA Fees, Fully Implantable Cochlear Implant & Terumo M&A (Sep 28–Oct 4, 2026)
MedTech news Sep 28–Oct 4, 2026: FDA FY2027 fees, a fully implantable cochlear implant, cardiac ablation software, Terumo M&A and Japan reimbursement updates.
Read moreGlobal MedTech News | FDA Biocompatibility, PMDA Foreign Manufacturers & BCI Funding (Sep 21–27, 2026)
MedTech news Sep 21–27, 2026: FDA biocompatibility, PMDA foreign manufacturer registration, CMS lab payment rates, device clearances and BCI funding.
Read moreGlobal MedTech News | PMDA GenAI Guidance, FDA-Cleared Robotic Endoscopy & Funding (Sep 14–20, 2026)
Key MedTech news for Sep 14–20, 2026: PMDA's GenAI SaMD draft, FDA-cleared robotic endoscopy, Hugo RAS, EU AI certification, Japan reimbursement and funding.
Read moreMedTech News | FDA AI Rule, Autonomous AI & M&A | Sep 7–13, 2026
Key MedTech news for Sep 7–13, 2026: FDA cardiovascular AI rules, ISO 10993-1:2025, Korea DTx guidance, autonomous heart-failure AI, M&A and Fujifilm MRI AI.
Read moreGlobal Medical Device News | AI, LLMs, Robotics & Japan Reimbursement | Aug 31–Sep 6, 2026
Read moreGlobal Medical Device News | AI Medical Devices, Endoscopy AI, and PFA Investments [August 24–30, 2026]
Between August 24 and 30, 2026, the medical device and MedTech industry saw a succession of new developments in AI-powered diagnostic support, endoscopes, surgical navigation, and cardiovascular interventions. Below is a summary of major domestic and international news, including new FDA approvals, new technologies from PENTAX Medical and Fujifilm, major investments in the PFA field, and a cybersecurity incident involving Boston Scientific.
Read moreGlobal Medical Device News | FDA Generative AI Discussion Paper & Automated Blood Drawing Robot De Novo Authorization (August 17–23, 2026)
Key medical device and MedTech news for August 17–23, 2026, covering the FDA's generative AI discussion paper, De Novo authorization of an automated blood-drawing robot, Alzheimer's blood testing, MedTech investment, and regulatory developments in Japan and Asia.
Read moreGlobal Medical Device & MedTech News (August 3–16, 2026): FDA Regulatory Overhaul, Major MedTech M&A, and Japanese Reimbursement
Here is a summary of key news from August 3 to 16, 2026, including the upcoming FDA user fee program, US rapid coverage pathways, major MedTech M&A, recalls, and medical device insurance reimbursement in Japan.
Read moreGlobal Medical Device News (July 27 - August 2, 2026): FDA Approval for Colorectal Cancer Blood Test, Major Investment in AF Treatment, Medical Device Recalls in Japan
Here's a summary of the major MedTech news from July 27 to August 2, 2026, including Freenome's FDA approval for its colorectal cancer blood test, significant funding for CoreMap, and medical device recalls in Japan.
Read moreGlobal Medical Device News: New Developments in J&J Surgical Robots, Fujifilm MRI, and Vision Restoration BCI
In medical device news from July 20-26, 2026, key highlights included FDA approval for J&J's Ottava surgical robot, Fujifilm's launch of a new open MRI model, European market launch of a vision restoration BCI, blood pressure wearables, and expanded reimbursement for insulin pumps.
Read moreGlobal Medical Device News: Abbott Vascular Scaffold, Smith+Nephew Laryngeal Wand, Newronika DBS, and M&A Activity
In medical device news from July 13-19, 2026, key highlights included Abbott's vascular scaffold FDA approval, Smith+Nephew's laryngeal wand launch, Newronika's adaptive DBS CE mark, HistoSonics' non-invasive tumor treatment CE mark, and M&A involving Medtronic and DePuy Synthes.
Read moreWorld Medical Device News: J&J Atrial Fibrillation Ablation, hinotori European Approval, New Developments in AI Ultrasound
In medical device news from July 6-12, 2026, notable developments included atrial fibrillation ablation, surgical assistance robots, AI ultrasound, TMS robots, intubation support systems, and vascular access devices for dialysis.
Read moreGlobal Medical Device News: Roche's New NGS, Edwards' Left Atrial Appendage Clip, Thyroid RFA, and Advancements in Endoscopic Suturing Devices
In medical device news from June 29 to July 5, 2026, there were significant new product developments, including Roche's next-generation sequencer, Edwards' left atrial appendage occlusion clip, StarMed's thyroid RFA, Terumo's intracoronary imaging, and the EndoZip endoscopic suturing device. Additionally, important safety news included a Class I recall for Terumo's thoracic stent graft.
Read moreGlobal Medical Device News: Trends in Surgical Robots, Structural Heart Disease, Wearable Regulations, and Neurotech
The medical device news in the fourth week of June 2026 highlighted surgical robots, structural heart disease, wearable regulations, neurotech, and recall/safety information.
Read moreGlobal Medical Device News: TAVR Reimbursement Expansion Proposal, Thrombectomy Devices, and Advances in Minimally Invasive Treatment Development
In medical device news for the third week of June 2026, notable developments included proposed expansion of TAVR reimbursement in the US, thrombectomy devices in the neurovascular field, significant investment in contact lens manufacturing, and progress in the development of minimally and non-invasive treatment technologies.
Read moreMedical Device Industry News | June 8 - June 14, 2026
Explaining Medical Device Industry News from June 8-14, 2026. This article summarizes developments from Penumbra's stroke treatment device, Danaher's acquisition of Masimo, DermaSensor's CE Mark, KARL STORZ, Medtronic, ADA 2026, and Terumo IR Day.
Read moreMedical Device Industry News June 8, 2026 | FDA, PMDA, M&A Trends
Medical Device Industry News from June 1-7, 2026, Explained from a Regulatory Perspective This article summarizes: Medtronic Hugo's 510(k) application, Edwards' tricuspid valve device, M&A involving Dexcom and ResMed, FDA 510(k) exemption guidance, and PMDA's updated SaMD review points.
Read moreMedical Device Industry News | May 25 - June 1, 2026 | M&A, CE Mark, FDA De Novo, Quality Management
Medical Device and MedTech Industry News Digest: May 25 – June 1, 2026. We will explain key trends in M&A, regulation, quality, and financial results, including Olympus's acquisition of BioProtect, Abbott's Libre Duo CE mark acquisition, Insulet's Omnipod quality response, Neurovalens' FDA De Novo authorization, and Fisher & Paykel Healthcare's full-year financial results.
Read moreMedical Device Industry News Weekly | Latest Trends in TAVR, Neurostimulation, and Surgical Assist Robots (May 18-24, 2026)
We will summarize medical device industry trends from May 18-24, 2026, from the perspective of regulatory affairs and Japanese market introduction. Key topics include Medtronic's acquisition of SPR Therapeutics, Boston Scientific's investment in MiRus, Intuitive Surgical's da Vinci 5 update, Artivion's acquisition of Endospan, Guardant Health's FDA approval, and financial results from domestic medical device manufacturers.
Read moreMedical Device and Healthcare Industry Weekly News Report (May 11 - May 17, 2026)
Medical Device & Healthcare Industry Weekly News | Regulatory Affairs & Business Development Trends from M&A, Recalls, and Financial Results
Read moreMedical Device & Pharmaceutical Affairs News Weekly Roundup | Revisions to Adverse Event Reporting, Endoscopic Robots, Medical AI, and Trends in Regenerative Medicine Products [May 3 - May 11, 2026]
Medical Device and Pharmaceutical Affairs News from May 3-11, 2026, compiled from a regulatory consultant's perspective. We summarize the operational review of malfunction reports accompanying the MHLW Ordinance amendment, endoscopic robots, surgical support AI, regenerative medical products, and financial trends of medical-related companies.
Read moreMedical Device Industry Weekly News (April 27 - May 2, 2026) | PMDA, FDA, M&A Trends
Q1 Earnings of Intuitive Surgical and Stryker, Strategic Acquisitions by J&J and CareDx, TaeWoong's SPAXUS Stent FDA 510(k) Clearance, Cyberattacks, and EU AI Act Trends: A GI Endoscopy Perspective by MK Consulting
Read moreCOMPANY
Company News
01
Japan Market Entry
Medical Device Registration & Market Entry in Japan
Plan medical device market entry in Japan: classification, approval, certification, notification, MAH/DMAH, QMS, labeling and reimbursement.
Medical Device Regulatory Requirements in Japan
Understand Japan's medical device requirements: PMDA and RCB roles, classification, approval, certification, notification, MAH/DMAH, QMS, labeling and post-market duties.
What Is a DMAH?
Learn the role of a DMAH for foreign medical device manufacturers in Japan, including approval and certification activities, QMS, post-market safety, change control, and contract points.
Japan Medical Device Approval Timeline and Costs
Learn how to estimate the timeline and cost of a medical device approval in Japan, including PMDA review, consultation, QMS conformity assessment, testing, dossier preparation, and inquiry responses.
In Vitro Diagnostic (IVD) Regulation and Registration in Japan
Guide to Japan IVD regulation, including classification, notification, certification, approval, performance evaluation, QMS, labeling and market entry.
02
Classification
Medical Device Classification in Japan
Learn how Japan's medical device Classes I–IV, generic device names, JMDN codes and certification standards determine the applicable regulatory pathway.
How to Find a JMDN Code
Learn how to identify a JMDN code for a medical device in Japan using PMDA generic name search, definitions, device classification, certification standards, and similar products.
How to Check Medical Device Certification Standards in Japan
Learn how to check Japan's medical device certification standards using JMDN codes, generic names, device classification, certified product lists, and the scope of third-party certification.
How to Search the Certified Medical Device List in Japan
Learn how to search Japan's certified medical device list by trade name, generic name, certification number, certificate holder, and Registered Certification Body, and how to check the corresponding JMDN code separately through PMDA's generic name search.
How to Search Medical Device Package Inserts in Japan
Learn how to search PMDA's medical device database by trade name, generic name, approval or certification number, and review intended use, structure, directions, warnings, and contraindications.
New, Improved, and Generic Medical Devices in Japan
Learn how Japan distinguishes new, improved, and generic medical devices for approval applications, including comparison with previously approved devices, clinical data, and required documentation.
Certification vs Approval for Medical Devices in Japan
Compare third-party certification and marketing approval for medical devices in Japan, including RCBs, certification standards, QMS and application documents.
Medical Device Labeling and Package Inserts in Japan
Prepare Japanese medical device labeling, package inserts and IFU consistent with approval or certification, safety information, QMS and change control.
03
PMDA Submissions
What is SaMD? Early development questions for the Japanese market
Understand SaMD status, evidence planning, PMDA consultation and software-specific issues in Japan. Discuss your product and the support it needs.
Guide to PMDA Consultations and Face-to-Face Advice
Learn how PMDA consultations for medical devices in Japan work, including free and paid consultation options, consultation categories, application flow, and how to prepare effective consultation materials.
Medical Device Approval Process in Japan
Learn Japan's medical device approval process, from generic name and classification confirmation to application category, PMDA consultation, dossier preparation, QMS conformity assessment, review, and post-approval launch.
How to Use CE Marking Documentation for Medical Device Applications in Japan
Learn how EU MDR Technical Documentation, GSPR, CER, risk management and test reports can be mapped to medical device approval or certification applications in Japan.
2025 PMD Act Amendment: What Medical Device Companies Should Review
Review practical points for medical device companies responding to Japan's 2025 PMD Act amendment, including applicability, effective dates, QMS, safety and change control.
Regulatory Points for GI Endoscopy Medical Devices in Japan
Regulatory points for ERCP, EUS-BD, biliary and pancreatic stents, and endoscopic devices in Japan, including JMDN, class, application route, clinical evaluation and reimbursement.
04
Clinical Evaluation
Clinical Evaluation Report (CER) Preparation Guide for Japan
Learn how to prepare a Clinical Evaluation Report (CER) for a medical device application in Japan, from defining the intended use and evaluation scope to literature search, data appraisal, analysis, and PMDA consultation.
Preparing a Medical Device STED in Japan
Learn how to prepare STED for a medical device approval application in Japan, including its relationship with the application form, Essential Principles, risk management, test reports, and clinical evaluation.
Medical Device Testing Requirements in Japan: Performance and Safety Evaluation
Japan medical device testing requirements: performance, biocompatibility, electrical safety, EMC, sterilization, software, cybersecurity and overseas data.
Essential Principles Conformity Checklist for Medical Devices in Japan
Learn how to prepare an Essential Principles conformity checklist for a medical device application in Japan, including applicability, standards, tests, supporting evidence, risk management, and STED consistency.
Biological Safety Evaluation of Medical Devices
Learn how to plan biological safety evaluation for a medical device application in Japan using ISO 10993, contact conditions, materials, manufacturing processes, chemical characterization, and existing data.
05
QMS & Reimbursement
Preparing for QMS Conformity Assessment in Japan
Learn how to prepare for Japan's medical device QMS conformity assessment, including manufacturing sites, product groups, quality documents, records, CAPA, inquiries, and conformity certificates.
Post-Market Safety Management for Medical Devices in Japan
Learn Japan's post-market safety requirements for medical devices, including malfunction and safety information, PMDA reporting, recalls, safety measures, change control, and coordination with overseas manufacturers.
Medical Device Reimbursement in Japan
Learn how medical device reimbursement works in Japan, including A1, A2, B1, C1 and C2 categories, functional categories, applications and launch planning.
C1 New Functional Category Application in Japan
Learn how Japan's C1 new functional category is assessed, including comparators, clinical usefulness, pricing methods, premiums, foreign prices and evidence.