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Designated Marketing Authorization Holder (DMAH) Service

Foreign Special Approval System (FSAS)
and Designated Marketing Authorization Holder (DMAH)
The Japan's Ministry of Health, Labour and Welfare has established the Foreign Special Approval System (FSAS) that allows foreign manufacturers of Class II, III, and IV medical devices to obtain marketing approval and certification for those devices. The FSAS allows foreign manufacturers to obtain marketing approval and certification for these medical devices in their own name instead of the Marketing Authorization Holder, and allows foreign manufacturers to become deemed Marketing Authorization Holders.
If a foreign manufacturer adopts the FSAS, it must have a Designated Marketing Authorization Holder (DMAH) carry out the duties stipulated in Article 72-3 of the QMS Ordinance, as well as post-marketing safety management duties.

Micren Healthcare's DMAH Services

Introduction

When utilizing the Foreign Special Approval System (FSAS), it is required that a DMAH acts as the official point of contact for the submission of Pre-Market Approval applications, PMDA Pre-sub consultations, and insurance reimbursement requests.

Business Flow

Business flow under the
Foreign Special Approval System (FSAS)

service

Service

Designated Marketing Authorization Holder (DMAH) Service

A Designated Marketing Authorization Holder (DMAH) is an important partner in Japan, handling important regulatory matters. Micren Healthcare has obtained a Type I Marketing Authorization Holder license for medical devices from the Tokyo Metropolitan Government. By selecting us as an independent Designated Marketing Authorization Holder (DMAH) , you can ensure compliance with laws and regulations such as the QMS and GVP ordinances, enabling you to manufacture and market your medical devices in Japan. Our goal is to fully control the Pre-Market Approval (Certification) of your medical device, and contribute to your manufacturing and marketing in the Japanese market.

Preparing for
market release

1.

Support for Various Applications such as Pre-market Approval Application as a DMAH Preparation and submission for Pre-Market Approval (Certification) applications and response to queries

  • Preparation and submission of applications for Foreign Manufacturer Registration(FMR) and response to queries
  • Preparation and submission for QMS Conformity Assessment Applications and response to queries
  • Ensure to adjust clientʼs QMS in compliance with the Ministry of Health, Labor and Welfare Ordinance Notification No. 169
  • Support for GCP Conformity Assessment
  • Support for reliability inspection of non-clinical study
  • Support for pre-sub consultation of PMDA

2.

Support for Insurance Reimbursement as a DMAH

  • Support for pre-consultation with MHLW
  • Preparation and submission of insurance reimbursement request form
  • Coordination with academic societies and alignment with related medical treatment guidelines
  • Support for hearing by MHLW Medical Division, handling for review by the Hozaisen meeting

3.

Set-up for market release

  • Assist to set up release criteria
  • Assist to create a Certificate of Compliance (CofC)
  • Assist to set up labelling and barcode
  • JAN code setting, MEDIS registration
  • Coordination for storage, inspection, release, labeling etc. at the registered warehousing manufacturer for final product in Japan
  • Logistics coordination with distributors
  • Preparing Seihin-hyojunsho (Medical Device File)
Release
Judgement

4.

Release Judgement

  • Implementation of release judgment based on the release criteria
Post-marketing
Vigilance
Activities

5.

Post-marketing Vigilance Activities

  • Collect Safety Management Information (Search in JAAME Search、FDA MAUDE/MDR, etc.)
  • Adverse events reporting
  • Recall reporting

6.

Maintenance Management Service

  • QMS surveillance and renewal management
  • FMR renewal management
  • Maintain the DMAH Registration Control Sheet to monitor renewals

7.

Change Control to Pre-market Approval and Foreign Manufacturer Registration:

  • Mainly product design changes and management of registered foreign manufacturing establishments
  • Send the Confirmation Letters to clients each quarter and proactively manage any changes to the pre-market approval and the foreign manufacturer registration
  • If any changes, handle needed change procedures such as minor change notification or partial amendment application for products, and change notification for FMR (or new application, e.g., in case of site moving)
others
  • For Japanese companies, we mainly provide regulatory advice and support for venture medical device development.

Merit

The benefit of choosing an independent
Designated Marketing Authorization Holder (DMAH)

It is possible to have a Japanese distributor act as the manufacturer/distributor, but we do not recommend having a distributor act as the Marketing Authorization Holder (MAH) for the following reasons:

As the distributor holds the Pre-Market Approval (Certification) for the medical device as the Marketing Authorization Holder (MAH), the distributor has full control over the Pre-Market Approval (Certification) for that medical device in Japan.Using an independent Designated Marketing Authorization Holder (DMAH) allows flexibility in selecting distributors and sales networks.

If you change your distributor, you may no longer be able to manufacture and market your product under the Pre-Market Approval (Certification) that your distributor holds. In that case, you will need to apply for the Pre-Market Approval (Certification) again, which will be very costly and time-consuming.

The MAH or DMAH has access to technical information about the medical device, which may include design information. Using an independent DMAH ensures the confidentiality of the information and prevents it from leaking to distributors.

f the Japanese regulatory authorities take issue with defects or non-compliance related to your company or your medical devices, who will your distributors be trying to protect, themselves or you?

Implementation steps

Steps for introducing medical devices using the Foreign Special Approval System (in the case of Pre-market Approval Application)

service

Please contact us for more information
about our DMAH services in Japan.

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