MK Consulting K.K. helps overseas manufacturers plan medical device registration in Japan, from classification and JMDN confirmation to approval, certification and notification. We review the intended use, product characteristics and applicable standards to identify the appropriate pathway and the involvement of PMDA or a Registered Certification Body (RCB).
Registration planning also covers QMS, foreign-manufacturer and manufacturing-site requirements, Japanese labeling, and coordination with an appropriate MAH or DMAH. We help clarify responsibilities and organize the available documentation for the Japanese submission.
Confirm the Japanese generic device name, JMDN code, and classification to establish the device's regulatory position in Japan. For the detailed process, see “Medical Device Classification in Japan.”
Confirm whether the expected pathway is marketing notification, certification, or approval. For the overall regulatory framework, see “Medical Device Regulatory Requirements in Japan.”
For the approval stages and dossier preparation, see the medical device approval process in Japan.
Define the roles of the Japan-based Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH) and the division of responsibilities with the overseas manufacturer. For DMAH arrangements, see “DMAH requirements in Japan”
MK Consulting K.K. does not act as a DMAH. We support overseas manufacturers by helping assess suitable Japan-side MAH/DMAH arrangements, clarify roles and responsibilities, and coordinate the regulatory work required for market entry.
Review the target device, manufacturing sites, and manufacturing processes, and prepare the required QMS activities in parallel with the submission. For details, see “Preparing for QMS Conformity Assessment in Japan.”
Prepare Japanese statutory labeling and package inserts that are consistent with the notification, certification, or approval content rather than simply translating overseas labels or IFUs. For details, see “Medical Device Labeling and Package Inserts in Japan.”
For products used under Japan's health insurance system, review the relationship with existing procedure fees and functional categories for specified insured medical materials at an early stage. For details, see “Medical Device Reimbursement in Japan.”
Review the product overview, intended use, design and operating principle, and overseas regulatory status. Identify the likely generic device name, JMDN code, classification, certification standards, and regulatory pathway.
Review overseas technical documentation, test reports, clinical data, Clinical Evaluation Reports (CERs), and risk management documentation. Identify the evidence that may support the Japanese submission and any additional evaluation needed.
Where the application category, testing strategy, or clinical evaluation remains uncertain, identify the questions to discuss with PMDA.
Prepare the application, Summary Technical Documentation (STED), performance and safety evidence, and clinical evaluation alongside the Japan-based marketing arrangements, manufacturing site information, QMS, labeling, and Japanese electronic package inserts.
Ensure that the arrangements for shipment, sales, post-market safety management, collection of device safety information, and change control are ready to operate once the relevant approval, certification, or notification procedures are complete.
Where reimbursement is relevant, align the regulatory and reimbursement schedules when planning the launch date.
CE-marking documentation, FDA-related materials, overseas clinical data, and test reports may be useful in a Japanese submission.
However, the intended use, device range, generic device name, application category, standards, and comparators proposed for Japan may differ from those used overseas.
Map each existing document to the Japanese submission requirement it supports, rather than submitting the overseas package unchanged. Identify any additional explanations or data needed.
This page provides an entry point for foreign manufacturers reviewing the main considerations and steps for entering Japan.
For a more detailed explanation of PMDA, RCBs, classification, regulatory pathways, MAH/DMAH arrangements, QMS, and post-market requirements, see the regulatory requirements reference.
For in vitro diagnostic products, review the separate guidance on IVD regulation and labeling requirements in Japan.
Yes. You need the appropriate Japan-based marketing authorization arrangements. The roles of the MAH or DMAH should be determined according to the product and business structure.
No. You need to review the Japanese generic device name, JMDN code, classification, and certification standards, and complete the procedures required under the applicable Japanese regulatory pathway.
They may. Review the test standards, test samples, identity or equivalence to the device proposed for Japan, acceptance criteria, and differences from Japanese requirements.
Assess this when developing the regulatory strategy. Review the device's novelty, differences from approved devices, non-clinical tests, literature, and overseas clinical data. Seek PMDA advice where needed.
For relevant products, considering reimbursement alongside the regulatory submission makes it easier to plan the schedule through commercial launch.
For the official regulatory basis and current procedures, refer to the following primary sources.
We assess existing product, test and clinical documents and identify usable evidence, gaps and questions to resolve. You can request the stages you need: application forms and STED preparation, dossier consistency checks, and draft responses to regulatory inquiries.
MK does not act as the MAH or DMAH, or as the applicant or license holder. We support documentation and coordination, with responsibilities agreed with the applicant.
Share your product overview, overseas authorization status, available test reports, and the questions you want to resolve before entering Japan.
Discuss Your Registration Strategy