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Japan Medical Device Registration

Pharmaceuticals and Medical Devices Agency (PMDA) approval timelines and requirements

2-3 weeks

Typical Timeline

Device Classes

Yes

MDSAP Accepted

Required

Marketing Authorization Holder (MAH)

Japan Medical Device Registration Overview

Japan medical device registration through PMDA typically takes 2-3 weeks for Class I devices. The official PMDA target is 1 week, but realistic timelines include preparation, documentation review, and potential questions from regulators.Japan uses a 4-class (I, II, III, IV) risk-based classification system. Foreign manufacturers must appoint a Marketing Authorization Holder (MAH) to register devices in Japan. PMDA accepts MDSAP certification, which single audit satisfies pmda qms requirements. Registration is valid for 5 years.

Registration Timeline by Device Class

Japan uses a 4-class (I, II, III, IV) risk-based classification system.

Class I

Notification (Todokede)

Low Risk

Official

1 week

Realistic

2-3 weeks

• No QMS certification required

• Automatic acceptance

Class II

Certification (Ninsho) or Approval (Shonin)

Medium Risk

Official

3-9 months

Realistic

5-12 months

With Prior Approval

4-7 months

Accelerated with: MDSAP certification

• Ninsho: 3-6 months with JIS standards

• Shonin: 6-9 months without

GMP/QMS Required

Class III

Approval (Shonin)

High Risk

Official

9-12 months

Realistic

1-1.5 years

With Prior Approval

1-1.5 years

Accelerated with: MDSAP, Foreign clinical data (if GCP compliant)

• Foreign clinical data may be accepted

• Japanese bridging studies may be required

GMP/QMS Required

Class IV

Approval (Shonin)

Highest Risk

Official

1-1.2 years

Realistic

1.5-2 years

With Prior Approval

1-2 years

Accelerated with: SAKIGAKE designation, MDSAP

• Japanese clinical trials often mandatory

• Post-market studies required

Clinical Trial RequiredGMP/QMS Required

Expedited Pathways

SAKIGAKE Designation

Breakthrough/Pioneer Device designation for innovative devices

6 months review (vs 12 months standard)

Eligibility: Ground-breaking technology, Severe disease with high unmet need, Early development in Japan

Priority Review

Expedited review for serious conditions

10 months (vs 14 months standard)

Eligibility: Serious condition, Limited treatment options

Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Japan registration.

FDA 510(k)

STED documentation can be adapted

2-4 months prep

EU CE Mark

ISO 13485 applicable to Ordinance 169

2-4 months prep

MDSAP

Single audit satisfies PMDA QMS

3-6 months

Key Requirements

Marketing Authorization Holder (MAH) in Japan
Foreign Manufacturer Registration (FMR)
QMS certification (MHLW Ordinance 169)
Japanese labeling and IFU
JMDN classification

Registration Validity:

5 years

MDSAP Benefit:

Single audit satisfies PMDA QMS requirements

Registration Process Flowchart

Japan Medical Device Registration Process

Step-by-step PMDA registration process. Total estimated timeline: 2-3 weeks.

Step 1: Device Classification

2-4 weeks

Classify device under PMDA rules: Class I (Todokede), II-III (Ninsho), III-IV (Shonin).

Step 2: Appoint MAH/DMAH

4-8 weeks

Foreign manufacturers must appoint a Marketing Authorization Holder (MAH) in Japan.

Step 3: Foreign Manufacturer Accreditation

1-2 months

Step 4: QMS Compliance

2-4 months

PMDA conducts QMS/GMP audit of manufacturing site. MDSAP accepted as alternative.

Step 5: Pre-Submission Consultation

1-3 months

Recommended for Class III/IV devices. Discuss clinical data and testing requirements.

Step 6: Shonin/Ninsho Application

1-2 weeks

Submit application to PMDA (Shonin) or Registered Certification Body (Ninsho).

Step 7: PMDA Review

10-14 months

Technical review by PMDA. Average 10-14 months for Shonin (Class III-IV).

Step 8: Approval

2-4 weeks

MHLW issues approval. Device can be marketed in Japan through the MAH.

Summary: The Japan medical device registration process through Pharmaceuticals and Medical Devices Agency (PMDA) consists of 8 main steps: Device Classification → Appoint MAH/DMAH → Foreign Manufacturer Accreditation → QMS Compliance → Pre-Submission Consultation → Shonin/Ninsho Application → PMDA Review → Approval.

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Related Resources

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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.