Medical Devices Regulatory Services
in Japan

Overview

Japan is the second biggest market for Medical devices and is expected to reach US $74.4 billion by 2025. Key factors driving growth in the Japanese medical device market are:

  • Population increasingly skewed toward geriatrics
  • Increase in life-style diseases and chronic health conditions
  • A wider population base being covered under universal health insurance
  • Regulatory changes to facilitate innovative technologiesa

Though the market looks promising, the major barrier in tapping the market is the stringent Pharmaceuticals and Medical Devices Agency (PMDA) regulations that Medical Device companies must abide by.

Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) working under the Ministry of Health Labour and Welfare (MHLW)

Regulation: Pharmaceuticals and Medical Devices Act (PMD Act)

Regulatory Pathway: Pre-Market Submission or Pre-Market Certification or Pre-Market Approval

Authorized Representative: MAH/D-MAH

QMS Requirement:  Ordinance No. 169, MDSAP Certification

Assessment of Technical Data:  Third party for Class II devices and PMDA for Class III and IV devices

Validity of License: Unlimited

Labeling Requirements: PMD Act

Submission Format: Paper

Language: English and Japanese

Japan Medical Device Classification

Japan has a clear-cut device classification system. The devices are classified into 4 classes based on the risk associated with the device. The registration procedure, document requirements, Technical assessment varies with the class of the device.

Device Class

Risk

Class I

Low Risk

Class II

Low/Medium Risk

Class III

Medium/High Risk

Class IV

High Risk

Market Authorization Holder (MAH)

Foreign manufacturers should appoint a Market Authorization Holder (MAH) as a pre-requisite to market devices in Japan. However, the PMDA allows to appoint a Designated Market Authorization Holder (D-MAH). In the former case, MAH owns and controls the registration and certificate/approval of the product. In the latter case, Foreign manufacturer owns and controls the registration and certificate/approval of product and D-MAH acts as a representative in Japan. It is ideal to appoint a D-MAH rather than MAH as the process to change a D-MAH is easier than changing the MAH.

Foreign Manufacturer Registration (FMR)

All the foreign manufacturing companies which intend to export their devices into Japan must register themselves with the Ministry of Health, Labor and Welfare (MHLW). This registration procedure is called as Foreign Manufacturer Registration (FMR), which formerly was known as “Foreign Manufacturer Accreditation (FMA)” or “Accreditation of Foreign Manufacturers (AFM)”.

Japan Medical Device Registration

The registration pathway in Japan depends on various factors such as class of device, assigned JMDN, availability of predicate device and availability of associated Japanese Industrial Standard (JIS). Various registration pathways in Japan are detailed below -  

  • Pre-market Submission (Todokede): It applies to general Medical Devices (Class I), wherein manufacturers can file a pre-market submission to the PMDA. This is a notification, and no review/assessment by the PMDA will be conducted.
  • Pre-market Certification (Ninsho): It applies to Class II (and a limited number of Class III) devices, which have an associated certification standard (JIS), and which are subject to pre-market certification. The process is like the European CE Marking process, where reviews are outsourced to a third party like a Notified Body.
  • Pre-market Approval (Shonin): Some Class II and III devices with no specific certification standard and all Class IV devices are subject to the pre-market approval process, also known as Shonin. This application has to be submitted to the PMDA and ultimately obtain approval from the MHLW.

Process flow

Post Approval Medical Device Life Cycle Management

Freyr supports the foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as:

  • Post approval change management - modifications to existing Medical Device approvals such as, addition of new variants, accessories; addition of new indications of use among others
  • Maintenance of approvals and registration through timely payment of administrative and registration fees
  • Renewal of licenses
  • Liaising between Notified Body or PMDA and the manufacturer
  • Importation Management

Despite having an established medical device Regulatory framework, navigating through Japan’s device classification system and respective registration procedures may require proven expertise.

Freyr, as a strategic Regulatory partner, provides end-to-end Medical Device Regulatory services that span across quality control, classification, clinical safety, and market access. We assist clients in all the procedural challenges right from Regulatory intelligence to dossier preparation and submission to product registration.

Summary

Controls

Device Class

Risk / Classification Criteria

Approval Routes

Agency Timelines

General

Class I

Low Risk

Pre-Market Submission (Todokede)

NA

1 Month

Specified Controlled

Class II

Low/Medium Risk

Pre-Market Certification (PMC / Ninsho)

Notified Body

6 Months

Controlled

Class II

Medium Risk

Pre-Market Approvals (PMA / Shonin)

PMDA

9 - 24 Months

Highly Controlled

Class III

Medium / High Risk

Pre-Market Approvals (PMA / Shonin)

PMDA

9 - 24 Months

Highly Controlled

Class IV

High Risk

Pre-Market Approvals (PMA / Shonin)

PMDA

9 - 24 Months

Expertise

Freyr Expertise

  • Regulatory Due Diligence 
  • Device Registration
  • Submission Management to PMDA or notified bodies
  • MAH and D-MAH
  • Pre-Submission Clinical Trial Necessity (CTN) consultation 
  • Foreign Manufacturer Registration (FMR) 
  • Data reliability inspection 
  • QMS inspection 
  • Reimbursement Application Submission 
  • Labeling support
  • Translation support
  • Distributor identification and qualification