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As a professional and independent Designated Marketing

Authorization Holder (DMAH) and In-Country Caretaker (ICC) for medical devices,

we will contribute to your company's medical device business in Japan.

About us

Micren Healthcare provides professional and independent
Designated Marketing Authorization Holder (DMAH) and In-Country Caretaker (ICC) services for medical devices,
under a Type I Marketing Authorization Holder license.
Our goal is to manage the Pre-Market Approval (Certification) of medical devices manufactured
by foreign manufacturers as an independent third party,
and to contribute to your medical devices business in the Japanese market.

Services

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Designated Marketing Authorization Holder (DMAH) Service

Designated Marketing Authorization Holders (DMAHs) under the Foreign Special Approval System (FSAS) are required to establish a management system and implement and maintain post-marketing safety management activities based on the Ministry of Health, Labour and Welfare Ordinance No. 169 (QMS Ordinance), and the Ministry of Health, Labour and Welfare Ordinance No. 135 (GVP Ordinance).

Micren Healthcare has obtained a Type I Marketing Authorization Holder license from the Tokyo Metropolitan Government. By selecting us as an independent Designated Marketing Authorization Holder (DMAH), you can manufacture and market your products in Japan while ensuring compliance with laws and regulations such as the QMS Ordinance and the GVP Ordinance.

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In-country Caretaker Service for Clinical Trial

The Japan's Pharmaceuticals and Medical Devices Act (PMD Act) requires that sponsors who do not reside in Japan and wish to conduct clinical trials in Japan must appoint an In-country Caretaker who will request the clinical trial on their behalf.

Micren Healthcare has obtained a Type I Marketing Authorization Holder license. We also provide services as a Designated Marketing Authorization Holder (DMAH) to foreign manufacturers. In addition to our track record of supporting the operation of clinical trials in Japan as an In-country Caretaker, our extensive experience as a DMAH means we can fully handle proper customs management, medical device management, malfunction and adverse event reporting, and other GCP-related tasks.

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News & Regulatory Updates

2025.12.25 Notice of Website Renewal 2022.12.01 GNI Group invest to Micren Healthcareand form a joint venture with EPS Group 2021.06.18 Micren Healthcare is acquired by EP Mediate;
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2025.08.27 Regulatory update will be displayed. 2025.08.27 Regulatory update will be displayed. 2025.08.27 Regulatory update will be displayed.
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Resources

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Overview of Japan Medical Device Regulation
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coming soon

List of Regulatory Notifications (Tsuchi) and Office Memorand..
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coming soon

SaMD Classification and Registration in Japan
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