Do you want to enter Japan’s Medical Device Market?!
- But worried about Japan’s complicated laws and regulations and/or prefer to reduce contractors and middle persons?
Then we, ICST is here to help you overcome those obstacles!
ICST Regulatory Service Features
Various Licenses
Since we have acquired the Type I Medical Device Marketing Authorization Holder License (MAH License), we are able to handle Class I ～ Class IV medical devices. We are also able to provide services in medical devices’ acceptance inspection, packaging & labelling, warehousing and repair with our Highly Controlled Medical Device Sales License, Medical Device Manufacturing License and Medical Device Repair License.
Comprehensive Regulatory Services
- ・Check medical device eligibility
- ・Identify medical device classification
- ・Support in Foreign Manufacturer Registration (FMR)
- ・Support in medical device registration
- ・Support in medical device insurance coverage application
- ・Assist with Information Disclosure Request
- ・Support in medical device importation (Yakkan Shoumei)
- Etc.
Extensive Experience
We have a long track record in providing support to clients from several countries with various medical devices’ application and distribution as both MAH and DMAH in Japan.
Region：Asia, America, Europe, Canada and so on.
Type of medical device：Active, Non-active, Software, etc.
D/MAH Key Responsibilities & Application Methods
You need to assign a local entity that has a MAH License to be able to register medical devices in Japan and import them. The local entity can either be your MAH or DMAH.
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Marketing Authorization Holder (MAH)
- Key duties：
- ・Handle the FMR & product registrations and maintain the approvals
- ・Manage product quality & safety and ensure all of the manufacturing sites are compliant with Japan’s QMS Ordinance
- ・Manage post-market surveillance compliant with Japan’s GVP Ordinance
- ・Review and approve product release to the market
- ・Owner of product approvals
Etc.
- Marketing Authorization
- Domestic Quality Control Support
-
-
Foreign Restrictive Authorization Holder (FRAH)
- Key duties：
- ・Designate a MAH company
- ・Manage product quality & safety and ensure all of the manufacturing sites are compliant with Japan’s QMS Ordinance
- ・Owner of product approvals
- Marketing Authorization
- Quality Control
-
Designated Marketing Authorization Holder (DMAH)
- Key duties：
- ・Handle the FMR & product registrations and maintain the approvals
- ・Manage quality management specified for DMAH in Japan’s QMS Ordinance
- ・Manage post-market surveillance specified for DMAH in Japan’s GVP Ordinance
- ・Import products and manage domestic process with instructions from FRAH
- ・Review and approve product release to the market
- Domestic Quality Control Support
-
QMS : Quality Management System
GVP : Good Vigilance Practice
Outline of MAH Flow
- ・Target medical device：Class Ⅰ～Ⅳ
- ・Owner of product approval：ICST
*PMDA：Pharmaceutical and Medical Devices Agency
**ICST's facilities or other domestic facilities. Can be discussed.
Outline of DMAH Flow
- ・Target medical device：Class Ⅱ～Ⅳ
- ・Owner of product approval：Foreign Manufacturer （FRAH）
*PMDA：Pharmaceutical and Medical Devices Agency
**ICST's facilities or other domestic facilities. Can be discussed.
ICST Business Record
