Medical device reviews in Japan: how the PMDA fits into the system

1) Who regulates medical devices in Japan?

Japan’s medical device regulation involves two authorities: the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA).¹
PMDA explains the split clearly:

• MHLW handles administrative actions, such as guidance and the decision of product approval under the PMD Act, and also determines whether a product is considered a medical device.¹
• PMDA undertakes product review and post-market safety measures.¹

This division matters in practice: even when the final administrative decision is made by MHLW, PMDA’s scientific evaluation is central for products that require approval.

2) Classification drives the regulatory pathway

In Japan, medical devices are classified into four risk-based classes:
Class I (extremely low risk), Class II (low risk), Class III (medium risk), and Class IV (high risk).²

PMDA states that, to market devices in Japan, a foreign manufacturer must proceed via approval/certification or notification, depending on classification, and do so through a Japanese Marketing Authorization Holder (MAH) or an appointed Japanese manufacturer, in accordance with the PMD Act.²

Pathways by class (as described by PMDA)

PMDA lists the required procedures as:²

• Class I: Notification to the PMDA
• Class II:
  • If certification standards exist: Certification by a registered certification body
  • Otherwise: Approval of the MHLW
• Class III:
  • If certification standards exist: Certification by a registered certification body
  • Otherwise: Approval of the MHLW
• Class IV: Approval of the MHLW

PMDA also emphasizes that regardless of class, the MAH must ensure the device’s efficacy, safety, and quality based on evidence before submission.²

3) Where “PMDA review” happens for medical devices

For devices that require “Approval of the MHLW”, PMDA states that they must be evaluated for safety and efficacy by the PMDA (i.e., product review).³ It also notes that regulatory requirements for individual products are assessed case-by-case, and that these expectations are addressed through PMDA’s face-to-face consultation meetings (fees apply).³

4) What PMDA does during medical device reviews

PMDA highlights that medical devices span a wide range—from simple items like bandages to complex systems like MRI and pacemakers—and have varied use patterns and risk levels.⁴ It notes that high-risk medical devices (including examples such as artificial hearts and pacemakers) are evaluated by PMDA.⁴

PMDA describes several practical features of how it runs device reviews:⁴

• Target review times: PMDA sets review-time targets and works to meet them, including by increasing reviewer capacity.⁴
• Multidisciplinary evaluation: Review involves experts in medical engineering, biological engineering, biomaterials, and also specialists with degrees in medicine, dentistry, pharmaceutical science, and other fields for non-clinical, clinical, and biostatistical evaluation.⁴
• Expert input: PMDA uses Expert Discussions with external experts to enable more specialized reviews.⁴
• International harmonization: PMDA participates in IMDRF and incorporates international topics and standards such as those from ISO to improve its review system.⁴

5) A practical way to use this information

If you’re planning Japan entry, the PMDA pages point to a simple operating logic:

1. Confirm classification early (Class I–IV) because it determines whether you’ll notify, certify, or seek approval.²
2. If you will seek MHLW approval, plan for a PMDA-led scientific review of safety and efficacy, and use consultations to align evidence expectations.³
3. Build evidence and documentation that supports efficacy, safety, and quality, since PMDA explicitly places that responsibility on the MAH before submission.²

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Q&A (common questions teams ask)

Q1: Who makes the approval decision—PMDA or MHLW?

PMDA explains that MHLW is responsible for the administrative decision of product approval, while PMDA conducts product review and post-market safety measures.¹

Q2: What determines whether our device needs notification, certification, or approval?

PMDA states it depends on the risk class (I–IV) and whether certification standards exist for Class II/III devices.²

Q3: If our device is Class II or III, do we always need MHLW approval?

Not always. PMDA states that if certification standards exist, Class II/III devices can go through certification by a registered certification body; otherwise they require MHLW approval.²

Q4: When does PMDA perform the “product review”?

PMDA states that devices requiring MHLW approval are evaluated for safety and efficacy by PMDA (product review).³

Q5: Are PMDA requirements the same for every device?

PMDA states that regulatory requirements for products requiring approval are assessed case-by-case, and discussed via PMDA consultation meetings.³

Q6: What expertise is involved in PMDA’s device reviews?

PMDA describes multidisciplinary teams spanning engineering and biomaterials, and also clinicians and other specialists for non-clinical, clinical, and biostatistical evaluation, supported by external expert discussions.⁴

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References

Footnotes

1. PMDA, “Regulations and Approval/Certification of Medical Devices” (English) — Regulation of Medical Devices section. https://www.pmda.go.jp/english/review-services/reviews/0004.html ↩ ↩² ↩³ ↩⁴

2. PMDA, “Regulations and Approval/Certification of Medical Devices” (English) — Classification of Medical Devices and required procedures by class. https://www.pmda.go.jp/english/review-services/reviews/0004.html ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸

3. PMDA, “Regulations and Approval/Certification of Medical Devices” (English) — For Medical Devices that are required to be Approved section (PMDA evaluation; case-by-case requirements; consultations). https://www.pmda.go.jp/english/review-services/reviews/0004.html ↩ ↩² ↩³ ↩⁴ ↩⁵

4. PMDA, “Reviews” (English) — Medical Devices Reviews section (scope, high-risk devices, target review times, expert discussions, IMDRF/ISO). https://www.pmda.go.jp/english/review-services/reviews/0001.html ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸