PMDA Medical Device Approval and Certification by Class: MAH Pathway Guide

Quick answer

Japan regulates medical devices under the Pharmaceuticals and Medical Devices Act (PMD Act) through two authorities: the Ministry of Health, Labour and Welfare (MHLW) for administrative decisions and the Pharmaceuticals and Medical Devices Agency (PMDA) for product review and post-market safety. Devices are classified Class I through IV by risk. Class I general medical devices require pre-market notification (届出, todokede) to PMDA—no product review is conducted. Class II and III devices with established Japanese Certification Standards follow pre-market certification (認証, ninsho) by a Registered Certification Body (RCB); other Class II/III devices require MHLW approval (承認, shonin) after PMDA product review. All Class IV devices require MHLW approval with PMDA review. Regardless of class, a foreign manufacturer must market through a Japanese Marketing Authorization Holder (MAH), complete Foreign Manufacturer Registration (FMR), and satisfy Japan Good Manufacturing Practice (JGMP) quality management requirements under Ministerial Ordinance No. 169 before supply.

Who this applies to

This guide applies to:

• Foreign manufacturers planning to export medical devices to Japan
• Japanese Marketing Authorization Holders (MAH) responsible for device approval, certification, or notification
• Registered Certification Bodies (RCB) applicants seeking to understand the split between RCB and PMDA pathways
• Regulatory affairs teams mapping EU MDR, FDA 510(k), or other jurisdictions to Japan's Class I–IV framework

Device scope covers general medical devices classified under the PMD Act. In vitro diagnostics (IVDs) follow a parallel classification and pathway structure under MHLW rules; the MAH, FMR, and JGMP principles described here apply similarly.

Regulatory framework: MHLW and PMDA

PMDA's English review page states that MHLW is responsible for administrative actions—including guidance, approval decisions under the PMD Act, and determinations of whether a product qualifies as a medical device. PMDA undertakes product review for devices requiring MHLW approval and manages post-market safety measures including vigilance.

For market access, the critical distinction is not MHLW versus PMDA alone but which pre-market pathway your device class and product type trigger: notification, third-party certification, or full approval review.

Device classification overview

Japan classifies medical devices into four risk-based categories aligned with the GHTF/IMDRF framework:

Classification is determined by Japanese Medical Device Nomenclature (JMDN) codes and MHLW classification rules. Confirm your JMDN code and applicable Japanese Industrial Standards (JIS) or Director-General notifications before selecting a pathway—the same nominal "Class II" device may route to RCB certification or MHLW approval depending on whether a certification standard exists.

Class-by-class pathway table

The table below summarizes official PMDA pathway requirements. Japanese terms appear because they appear on application forms and MAH licenses.

PMDA publishes the list of Registered Certification Bodies on its website. For devices requiring certification, apply through the RCB's published procedures—not through PMDA's approval review queue.

Class I — pre-market notification (todokede)

Class I devices are general medical devices at the lowest risk tier. PMDA states that Class I devices require notification to the PMDA rather than certification or approval. No product review or assessment is conducted; the MAH submits a marketing notification using the prescribed form (Form 9 under the PMD Act enforcement regulations, as referenced in PMDA's manufacturing and marketing procedures guide).

Key implications for Class I:

• The MAH still holds a valid marketing authorization holder license appropriate to the device category
• Foreign Manufacturer Registration (FMR) and JGMP/QMS compliance remain prerequisites—the notification itself does not waive manufacturing quality obligations
• Labeling, intended use, and JMDN nomenclature must be accurate; post-market vigilance obligations apply after marketing begins
• Class I is not "unregulated"—it is notification-based rather than review-based

Because PMDA does not assess Class I dossiers, the MAH bears full responsibility for confirming the device is correctly classified as Class I and that safety and performance evidence supports marketing.

Class II — certification (ninsho) via RCB or MHLW approval

Class II covers a broad range of low-risk devices. PMDA divides Class II into two sub-pathways:

Pathway A: Certification by Registered Certification Body

When a Japanese Certification Standard exists for your device type, the product must be certified by an RCB designated by MHLW. PMDA notes that most Class II medical devices—and many Class II IVDs—follow this third-party certification process without PMDA product review or MHLW approval.

The RCB process typically includes:

1. Product review against the applicable certification standard (JIS, Director-General notification, or harmonized essential principles)
2. QMS inspection of the MAH and relevant manufacturers (including foreign sites registered under FMR)
3. Issuance of certification and a compliance certificate enabling the MAH to market the device

Certification standards are searchable on PMDA's Standards for Medical Devices database (std.pmda.go.jp).

Pathway B: MHLW approval after PMDA review

Class II devices without an applicable certification standard require Approval of the MHLW following PMDA product review—the same substantive review model used for higher-risk approval devices, though evidence expectations are proportionate to class.

Class III and Class IV — approval (shonin)

Class III devices are controlled medical devices at medium risk. Where certification standards exist, Class III may still route to RCB certification—a pathway that surprises teams accustomed to EU MDR where Class IIb/III typically require Notified Body involvement under different rules. Where no standard exists, Class III requires MHLW approval with PMDA safety and efficacy review.

Class IV devices are specially controlled—the highest-risk category including permanent implants and critical life-support equipment. All Class IV devices require MHLW approval after PMDA review. There is no RCB certification shortcut for Class IV.

For approval devices, PMDA evaluates regulatory requirements on a case-by-case basis. PMDA offers face-to-face consultation meetings (fees apply) to clarify evidence expectations before submission—strongly recommended for novel Class III/IV devices or those without predicate approvals in Japan.

PMDA publishes lists of approved new and improved medical devices (including those with clinical data) on its English review pages. Class IV labeling is publicly searchable on PMDA's device database (Japanese interface).

Marketing Authorization Holder (MAH)

Every medical device marketed in Japan—regardless of class—requires a Marketing Authorization Holder (MAH) licensed under the PMD Act. PMDA states that foreign manufacturers must obtain approval, certification, or submit notification through a Japanese MAH (or a Japanese manufacturer appointed by the foreign manufacturer).

MAH responsibilities

The MAH is the legal entity accountable for:

• Holding the approval, certification, or notification for the device
• Ensuring efficacy, safety, and quality based on evidence before submission—PMDA explicitly requires this for all classes
• Managing pre-market applications to PMDA, MHLW, or RCBs
• Maintaining post-market vigilance, adverse event reporting, and recall obligations
• Undergoing QMS inspection as part of certification or approval workflows

MAH licenses are category-specific under Article 23-2 of the PMD Act (e.g., general medical devices, controlled devices, specially controlled devices). The MAH license type must match the highest-risk device category in your portfolio.

MAH versus manufacturer

Foreign manufacturers do not replace the MAH. Even when a foreign manufacturer submits application documents directly to PMDA or an RCB, a MAH located in Japan must be designated. The MAH controls the marketing authorization; changing MAH requires regulatory procedures and is a common commercial negotiation point in distribution agreements.

Foreign manufacturer registration and manufacturing setup

Foreign manufacturers must complete manufacturing establishment registration before...