Service
Support Your Business
MDI Service
In order to distribute medical devices in Japan, regulatory approval (approval/certification/registration), applications are required to conform to the classification of the medical device (Class I to IV). In addition, manufacturing registration, MAH (Marketing Authorization Holder)/ DMAH (Designated Marketing Authorization Holder) licenses as well as sales licenses are required, depending on product classification and the role of the distribution chain.
We hold a First-class marketing license for medical devices, and can handle all medical devices, Class I to IV, and can supply services as MAH or DMAH.
We will also support our clients who are applying for foreign manufacturing registration in Japan, in order to enter the Japanese market, and/or provide other support, related to regulatory matters, on request.
Workflow image
The basic flow of work is as follows. We will provide specific support, following your request.
Inquiry
Phone/Email/Contacting form
The first stage is an informal request for our services.
Interview
Non-Disclosure Agreement in place in advance, if necessary
Discussion of the detail of a client’s request, followed by the setting of mutually agreed goals.
- Confirmation that the client’s product is classified as a medical device in Japan.
- Confirmation of the distribution scheme, clarifying which company license will be required.
- Other matters identified during the above discussion.
Quotation
A quotation for the services required by the client is prepared based on agreed goals
Contract
Regulation
Development of an action plan to launch the product (medical devices) in Japan, based on the above discussions.
- Confirmation of regulations and requirements.
- Preparation of the documents for the regulatory application.
- Other matters arising from the above process.
Regulatory application / support / outsourcing
Services are based on clients’ request.
- Support for regulatory applications (preparing application documents according to the class, application for foreign manufacturer registration, etc.)
- Support given for liaison between manufacturer and distributor.
- Other support, as required.
※QMS audit will be required for products above Class II.
Regulatory approval achieved
Following registration/certification/approval, importation to Japan.
Launch / Distribution
Services based on clients’ requests.
- MAH / DMAH services.
- Support for transportation (including importation)
- Other support, as requested and required.
Contact us for more information
Please feel free to contact to us with your requirements