Importing Medical Devices

Importing Medical Devices

Importing medical devices into Japan only requires three steps of regulation. Japan PMDA approval is a requirement.

1.       Medical Device Sales & Marketing License – only a Japanese company can obtain this license.

2.       Foreign Medical Device Manufacturer registration – this step is required before any product can be imported.

3.       Product Approval – this step allows the product to be imported into Japan.


If you are a foreign company without Japanese subsidiary, you are required to have an importer of record (IOR). The IOR can complete steps 2 and 3 on behalf of the foreign manufacturer.

Be sure to choose an IOR that does not place restrictions on your Japan sales channels. COVUE is perfect to pick as your IOR. We do not restrict sales channels. Distributors may also act as your IOR however, problems can occur if the distributor does not act as intended.

Process for Completing steps 2 and 3.

  • Register with COVUE IOR
  • Submit Product SKU
  • Sample Product Check
  • Regulation Analysis
  • Application of Foreign Factory & Shipper
  • Prepare Product Application
  • Submit Product Application
  • Document Work for Product Standards (Japanese)
  • Prepare Japanese Label (regulated/certified)
  • Prepare Shipping Documents
  • Customs Clearance
  • Receipt of Products in Licensed Warehouse
  • Inspect 1 pc of each product SKU
  • Product Document Control for MHLW
  • Confirm Labeling & Packaging
  • Delivery to Destination
It is important to check product eligibility. Not sure what category your product is? Check here
Ready to register IOR? Contact us!
    • Related Articles

    • Importing Electronics

      All products that hold or come into contact with food or liquid for human consumption require a food apparatus import application for every import.  Steps for importing Food Apparatus: 1. Register COVUE as your IOR 2. Submit product material and ...
    • Importing Non-regulated products

      Selling on Amazon Japan? Japan is one of Amazon’s fastest growing markets. It has the third-largest economy and the most populous city, Tokyo. Japan has a high consumer spending market. This provides perfect opportunities for Amazon sellers to ...
    • Importing Shelf-Stable Food

      If you are looking to import food into Japan, we will take care of that for you! A complete food import application for every shipment provided by the importer of record (IOR) is required by the Japan law. The food import application also requires ...
    • Importing cosmetics and baby care products

      Importing cosmetics or personal care is a two-step process for regulation. 1.       Foreign Manufacture registration – this step is required before any product can be imported. 2.       Product Approval – this step permits the product to be imported ...
    • Importing Food Apparatus such as Food containers, Utensils, Cooking pans and others

      Food apparatuses are products that come in contact with food or liquids that are intended for human consumption. Examples: -        Food containers -        Utensils / chopsticks -        Cooking pans/pots -        Food bags -        Food wraps   All ...