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Local Regulatory Experts

Connect with regulatory affairs consultancies specializing in this region.

Qualtech Consulting Corporation

Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA

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A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.

Cobridge Co., Ltd.

Tokyo, Japan

Registration

We assist medical device companies with the medical device registration and approval in Japan. Regulatory consulting services and DMAH services for foreign manufacturers to enter Japanese market.

MDREX, Medical Device, Digital Health Consulting Group

Seoul, Republic of Korea (HQ), Japan Office

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Distribution
Marketing

We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.

CMIC Holdings Co., Ltd.

Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia

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Marketing

We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.

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Registration

November 25, 2024

Approximately 5 minutes

Japan Medical Device Registration: Pathways and Requirements

Overview of Japanese Medical Device Registration

Medical device registration in Japan is governed by the Pharmaceutical and Medical Device Law (PMDL) and overseen by the Pharmaceuticals and Medical Devices Agency (PMDA) of the Ministry of Health, Labor and Welfare (MHLW). The process complexity, cost, and timeline depend heavily on the device's classification and whether a predicate device exists.

Device Classification

Devices are classified into four risk categories:

  • Class I: Low Risk
  • Class II: Medium Risk
  • Class III: High Risk
  • Class IV: Highest Risk

Classification uses the Japan Medical Device Nomenclature Code (JMDN code) system.

Key Requirement: The DMAH

Foreign manufacturers must appoint a local entity known as the Designated Market Authorization Holder (DMAH). The DMAH is responsible for:

  • Submitting all applications to the PMDA.
  • Holding the device license.
  • Communicating with the PMDA.

Registration Pathways

Japan utilizes three primary pathways for market entry:

  1. Pre-Market Submission (PMS) / Todokede

    • Applicable Devices: Low Risk Class I devices.
    • Process: Applications are submitted to the PMDA and considered accepted upon submission.
    • Timeline: Approximately one week for a PMS number.
    • Cost: No PMDA fee.

  2. Pre-Market Certification (PMC) / Ninsho

    • Applicable Devices: Most Class II and certain generic Class III devices with established specifications (AS/predicates).
    • Process: Review and Quality Management System (QMS) conformity assessments are outsourced to Registered Certification Bodies (RCBs).
    • Timeline: Average of 3 months.
    • Cost: Average around US$30,000 for the review.

  3. Pre-Market Approval (PMA) / Shonin

    • Applicable Devices: New devices across Class II, Class III, and Class IV.
    • Process: Reviewed directly by the PMDA. This pathway is required for "new," "improved," or non-generic devices, especially those lacking applicable JMDN codes or predicates.
    • Timeline: Varies widely, from 6 months to 36 months, depending on the need for local clinical evidence.
    • Cost: Varies from US$20,000 to US$120,000.

Quality Management System (QMS)

While ISO 13485 is not mandatory, manufacturers must comply with Japan's local Good Distribution Practice (GDP) requirements, as stipulated in MHLW Ministerial Ordinance No. 169 (2004).

License and Importation

  • License Validity: Medical device licenses in Japan do not expire.
  • Importation: The DMAH can authorize multiple importers to import products under a single license.

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Questions & Answers (4)

A
Guest

Our device is a high-cost robotic surgical tool. Even if we get PMDA approval, how do we ensure it is covered by the National Health Insurance (NHI)? What is the difference between A1 (Inclusive) and C1/C2 (New Category) reimbursement?

ElendiLabs

In Japan, regulatory approval and reimbursement are separate hurdles. Most devices fall into A1 or A2 (covered under existing procedure fees). However, if your device is a breakthrough technology, you may apply for a C1 (New Function) or C2 (New Category) listing. This is a complex negotiation with the MHLW that happens after approval. The price is determined based on a "Cost Calculation Method" or "Comparison with Similar Devices." We advise starting the reimbursement strategy during the PMDA review phase to minimize the "lag time" between approval and the first sale.

A
Guest

We want to enter Japan but don’t want our local distributor to hold our product license (Shonin) as we want the freedom to change distributors later. If we appoint one local entity as an Independent DMAH who technically "owns" the registration in the eyes of the PMDA and can we ship to multiple different distributors?

ElendiLabs

Under the PMD Act, the Marketing Authorization Holder (MAH) or DMAH is the legal owner of the registration. If your distributor acts as the MAH, they control your "market access." By appointing an independent DMAH (like a third-party service), you retain control of the license. The DMAH acts as your regulatory anchor in Japan, allowing you to appoint and manage multiple "Sellers" (distributors) without needing to re-register the product if you terminate a sales partnership.

A
Guest

We have extensive clinical trial data from the US and Europe for our new cardiovascular stent. Will the PMDA accept this foreign data, or will they require a "Bridging Study" on Japanese patients to account for ethnic differences in anatomy or response?

ElendiLabs

Japan has become more flexible via the "Global Clinical Trial" framework, but the PMDA still evaluates "Ethnic Factors" (as per ICH E5 guidelines). For high-risk devices (Class IV), the PMDA will look at whether the Japanese population's physical dimensions or metabolism could lead to different safety outcomes. In many cases, if you can provide a scientific justification that the "ethnic factors" are negligible, you can avoid a domestic trial. We highly recommend a PMDA Pre-submission Consultation to confirm if your US/EU data is sufficient before you file.

A
Guest

We have an AI-based diagnostic software (standalone) for dermatology. Since this doesn't have a "physical" hardware component, is it still regulated under the PMD Act, and what is the difference between a Ninsho (Certified) and a Shonin (Approved) application for SaMD?

ElendiLabs

Yes, SaMD has been regulated as a medical device in Japan since 2014. The pathway depends on "JMDN" (Japanese Medical Device Nomenclature) codes. If a "Third-Party Certification" (Ninsho) standard exists for your specific software type (Class II), the process is faster (approx. 4–6 months). However, for innovative AI diagnostic tools that don't fit existing codes, you must go through the "PMDA Approval" (Shonin) route (Class III), which requires a more rigorous review of your clinical algorithm and potentially a consultation meeting with the PMDA to agree on the evaluation criteria.

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Contact us at contact@elendilabs.com / +852 4416 5550

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