Import of medical devices
We have extensive experience in importing medical device
Since our company was founded, we have imported many of the latest medical devices from overseas. We are licensed as a Class I Medical Device Manufacturer and MAH (Marketing Authorization Holder) of medical device, so we can handle all medical devices from Class I to Class IV, from import to marketing, as a one-stop services.
Integrated handling process from import license acquisition to market delivery
- Prior to obtaining licenses
- Support for applications for approval/certification/notification (Class I-IV):Regulatory Solutions
- Prior to obtaining licenses
- Support for QMS audit (when obtaining a product approval and/or a certification) :Regulatory Solutions
- After obtaining licenses
- Import customs clearance instructions: MAH
- After obtaining licenses
- Quality inspection, regulatory labelling, storage of finished products: Manufacturer
- After obtaining licenses
- Shipping judgment to the domestic Marketing: MAH
- After obtaining licenses
- Delivery to the domestic Marketing: Manufacturer
Designated Marketing Authorization Holder (DMAH) Service
We have obtained the Class I MAH (Marketing Authorization Holder) required for working as a Designated Marketing Authorization Holder (DMAH). By outsourcing to us, you can omit obtaining the MAH (Marketing Authorization Holder) License and the Manufacturer License required by Japanese laws and regulations that allows you to import medical devices into Japan at sooner.
We have also obtained a Manufacturer License that allows us to perform “Storage of final products in Japan”, making it possible for us to provide one-stop services up to shipment of medical devices to the Japanese market once we have obtained the license and approval of your product.
Main role of each business license
As a Manufacturer
Storage of finished products
Trained staff members conduct detailed quality inspections based on the requirements of each product.
Products that pass the inspection are legally labeled and stored.
As a Marketing Authorization Holder
Import customs clearance instructions
The MAH, as the importer of the medical device, provides customs clearance instructions.
Shipping judgement to the Japanese market
In order to distribute a product domestically, a shipping judgement must be obtained from the MAH (or DMAH) of the product in question.
Operations of MAH after shipment
- Quality Assurance Operations
Report defects to foreign manufacturers, request improvements, and conduct periodic checks. - Post-marketing safety control operations
Collects post-marketing product safety information, handles complaints, etc.
