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What Should You Watch Out for in Japan High-Risk Registration? Do You Need Clinical Trials? CMEF Open Class Highlights

Time：2026-10-27 11:12:57

As an important global medical market, Japan has a rigorous regulatory system. Particularly for Class III/IV high-risk medical devices, the registration threshold is high and the timeline is long. Many domestic medical device manufacturers frequently encounter pitfalls in classification determination, legal representative qualification, clinical evaluation and PMDA communication when expanding into Japan.Based on the open class held at CMEF Beijing, this article sorts out the full registration process for medical devices in Japan, core points for high-risk products and common pitfalls to help domestic medical devices successfully enter the Japanese market.

一、Japan Medical Device Risk Classification

Medical devices in Japan are classified based on the harm caused by product failure to the human body：

Classification	Risk Level	Typical Products	Application Route	Reference Timeline
Class I	Extremely low risk	Glasses, surgical scalpels, forceps, stethoscopes	PMDA Notification	~1 month
Class II	Low risk	Sphygmomanometers, magnetic therapy devices, massage devices, MRI	Third-party certification if certification standard available; PMDA Approval Application if no applicable standard	6 months – 1 year
Class III	High risk	Contact lenses, dialysis machines, implants	PMDA Approval Application, multiple formal consultations required	More than 1 year, clinical data required in most cases
Class IV	Highly invasive, life-threatening	Cardiac pacemakers, vascular stents	PMDA Approval Application, multiple formal consultations required	More than 2 years, clinical data basically mandatory

Important Note：Not all Class II products follow third-party certification. If no corresponding certification standard exists, they need to submit a PMDA Approval Application just like Class III/IV products. For Class III and IV high-risk devices, multiple formal consultations with PMDA throughout the review process are standard practice.

二、Complete Registration Workflow

Overseas manufacturers cannot submit registration applications directly in Japan. The full market access workflow consists of 5 key steps：

（一）Confirm Product Classification & Application Route

Determine the Class level according to product intended use, structure and risk, and select the filing / certification / approval pathway. This step directly defines the subsequent document framework, budget and project timeline. Misclassification will lead to project rework.

（二）Appoint Japan Local Marketing Authorization Holder: MAH / D-MAH

Regulations mandate overseas manufacturers to entrust a local Japanese entity：

MAH(Marketing Authorization Holder)：License holder bearing full legal responsibility for the product

D‑MAH(Designated Marketing Authorization Holder：Agent entity dedicated to supporting overseas manufacturers

No registration application can proceed without a MAH or D-MAH.

（三）Foreign Manufacturer Registration (FMR)

Domestic manufacturing sites complete Foreign Manufacturer Registration (FMR), a precondition for registration to verify site compliance. Manufacturers shall hold an ISO 13485 certificate and complete quality system documentation.

（四）Submit Product Registration Application

ClassⅠ：PMDA Notification；

ClassⅡ：Third-party certification via recognized certification body if applicable standard exists; PMDA Approval Application if no applicable standard；

Class III / IV：PMDA technical review + MHLW approval. Submission includes STED technical documentation, risk management files, performance test reports and full QMS quality system records.

（五）Obtain Authorization for Legal Marketing

Products can only circulate and sell in Japan after obtaining the notification number / certification certificate / approval number, while continuously complying with QMS and post-market vigilance (GVP) obligations.

三、Mandatory Qualifications for All Stakeholders

The whole supply chain from domestic factories to Japanese distributors has qualification requirements：

Domestic Manufacturer：Complete FMR registration with PMDA, prepare ISO13485 certificate and full system documents

Warehouse：Obtain medical device manufacturing registration and appoint full-time managers with science & engineering background

Importer：Acquire Class 1/2/3 Manufacturing & Sales License matching device risk class; must appoint General Manager, Quality Manager and Safety Manager

Distributor：Distributors of Class III/IV and specially maintained devices need High-Risk Medical Device Sales License; other Class II products only require sales notification and a responsible person with science & engineering background

All licenses and notifications are filed with the local Japanese government authority where the company is located.

四、Core Registration Points for High-Risk Devices (Class III/IV)

High-risk devices follow the Approval Application pathway. Competitor benchmarking, substantial equivalence assessment and PMDA consultation are three core pillars.

（一）Competitor Benchmarking: Foundation of Application Strategy

Prior to submission, benchmark against similar devices already approved in Japan:

Selection principle: Prioritize products already approved in Japan with similar intended use and working principle; verify official approval numbers and approved indications. Mark information as pending confirmation if public data is insufficient; do NOT presume equivalence subjectively.
Key comparison dimensions: Clinical intended use (target population, treatment site), technical features (construction, raw material, performance), usage conditions (operation method, sterilization, shelf life, reusability)
Deliverable conclusion: Clarify each difference, its impact on safety & effectiveness, and supporting evidence. Superior performance on a single indicator does NOT automatically prove substantial equivalence; risk-benefit must be comprehensively evaluated.

（二）Difference Type A/B/C – Decides Whether Clinical Trials Are Required

PMDA categorizes deviations from predicate devices into three types, which directly determine if clinical trials are required:

Difference A (Within Substantial Equivalence · Follow-on Device)：Product structure, performance and intended use are substantially equivalent to the approved predicate. Registration clinical trials are generally not required; arguments rely on in vitro tests, animal studies and other non-clinical evidence.

Difference B (Modified, No Clinical Required)：Beyond substantial equivalence, yet the safety and effectiveness impact of the modification can be fully evaluated by performance tests, simulation studies, animal studies and other non-clinical means, with no human clinical trials needed.

Two conditions must both be satisfied：① Deviation breaks substantial equivalence; ② Non-clinical data fully covers associated risks.

Difference C (Modified, Clinical Required)：Non-clinical data alone cannot confirm therapeutic effect and risks for Japanese target patients, human clinical evidence is mandatory.

Note：This does NOT automatically require new clinical trials conducted in Japan. Overseas clinical data and published literature can be evaluated for applicability. New clinical trials are only considered when existing evidence cannot support evaluation. Overseas clinical data needs assessment for ethnic differences and adaption to local Japanese clinical practice.

（三）Leverage PMDA Consultation System to Reduce Review Risks

PMDA provides multiple consultation services, ranging from free general guidance to paid dedicated face-to-face meetings. Consultation in advance at key project stages is recommended to reduce later deficiency letters.

Consultation Type	Fee	Core Purpose
General Inquiry	Free	Regulatory guidance & consultation channel introduction
Pre-development Consultation	Paid	Product development roadmap, document framework, preliminary judgement of clinical necessity
Non-clinical Protocol Consultation	Paid	Evaluation of performance & safety test protocols and results
Clinical Trial Necessity Consultation	Paid	Judge whether additional human clinical trials are needed
CER Clinical Evaluation Report Consultation	Paid	Confirm acceptability of the clinical evaluation report
Simplified Consultation	Paid	Procedural confirmation for minor changes and notifications

or high-risk projects, PMDA consultation is strongly recommended to align review expectations early and avoid massive deficiency letters after submission.

五、Common Registration Pitfalls

Based on practical project experience, registration failure and repeated deficiency letters mostly stem from the following six issues:

Wrong product classification & application pathway：Incorrect JMDN coding, submitting approval application when certification is applicable; improper predicate selection that fails to support substantial equivalence.

Defective STED technical files：Internal contradictions in documents, translation errors from Chinese source files into Japanese (PMDA is highly sensitive to this), missing descriptions for algorithms and measurement principles.

Performance tests fail Japanese requirements：Direct adoption of test reports originally for China or CE standards; insufficient statistical justification for sample size; test models decoupled from real Japanese clinical scenarios.

Formalistic risk management：ISO 14971 risk analysis using generic templates; risk control measures not mapped to product design; inadequate residual risk analysis.

Gaps in sterilization & biocompatibility：Sterilization validation non-compliant with ISO 11135; missing data on repeated sterilization impact on product performance; incomplete biocompatibility evaluation following ISO 10993.

QMS audit issues：ISO13485 certificate scope inconsistent with the applying product; unclear manufacturing flowchart; missing records for equipment calibration, process validation and batch production, which may cause failure in document review or on-site inspection.

六、Closing Remarks

Registration of domestic high-risk medical devices for Japan market is far more than compiling a set of technical documents. It requires building a full compliance system, covering early classification and pathway assessment, MAH/D-MAH setup, FMR registration, predicate comparison, substantial equivalence analysis, PMDA consultation, QMS audit and continuous post-market compliance.For further inquiries, please contact Wiselink!

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