MDI JAPAN
MDI JAPAN, Inc was established in 1993. We provide regulatory services and consulting related to medical devices, medical supplies as well as other products. Our goal is to provide a Japanese partner for all parties involved, and we support our clients, patients and end users via placing high priority on communication with manufacturers and distributors.
Our Services
We hold a First-Class marketing license for medical devices, can handle all medical devices Class I to IV, and we are mainly engaged in MAH (Marketing Authorization Holder) services in Japan. We can also supply DMAH (Designated Marketing Authorization Holder) services.
MAH is responsible for QMS (Quality Management System) and GVP (Good Vigilance Practice) – response to product failures and adverse events, and responsible for the product regulatory approval (registration – Class I, certification/approval – Class II, III, IV).
MAH monitors the life cycle of the product, from its origin to its disposal, post-usage.
In order to apply for product regulatory approval, we research the origin of the product, directly via the manufacturer developing the product, research the product’s features, research the production process, including use of the product after transportation from the manufacturer to the medical site, taking into account how effectively the improvement that feedback, based on experience of the product in use, leads to next-generation products.
Based on the above research-based data, we provide the following services.
MAH (or DMAH) services
We provide MAH / DMAH services in Japan. In respect of MAH (Marketing Authorization Holder) responsibilities, the MAH will have full responsibility for QMS (Quality Management System) and GVP (Good Vigilance Practice – defined as response to product failures and adverse events), once MAH has obtained the product regulatory approval (registration – Class I, certification/approval – Class II, III, IV) based on a client’s request. In respect of DMAH (Designated Marketing Authorization Holder) responsibilities, the DMAH will make an application for the product regulatory approval (certification/approval – Class II, III, IV) on behalf of a client, after a client has requested MAH. A Client will therefore have the necessary product regulatory approval and proxy DMAH, in order to operate QMS and GVP in Japan. * Our DMAH service can be used beyond Class II products, as the Class I product category involves registration only, and the DMAH system is therefore not applicable, based on current regulations.
Regulatory application / application support service /outsourcing service
In order to distribute medical devices in Japan, it is necessary to obtain product regulatory approval (registration – Class I, certification/approval – Class II, III, IV). For such applications, related materials /supporting documents and product data need to be submitted. We provide full support for the necessary tasks related to obtaining these regulatory approvals.
Support for complying with QMS Ordinance:
When supplying medical devices to Japan, compliance with QMS ordinance, QMS (Quality Management System) is necessary. QMS ordinance is based on ISO13485:2016, and the ordinance has additional requirements. Foreign Manufacturers are also required to meet these requirements. We provide support for satisfying QMS ordinance requirements. We also provide for QMS audit.
Transportation and Communication support:
We provide support for transportation between a supplier abroad and Japan, including importation. We also support the communication between the foreign manufacturer and the Japanese distributor.
Contact us
Please feel free to contact to us with your requirements, when:
- Searching for a MAH/DMAH company
- Searching for support in obtaining regulatory approval
- Searching for transportation and communication support.
