Importing Medical Devices into Japan

Importing medical devices into Japan requires Japan PMDA (FDA) approval. There are three steps of regulation:

  1. Medical Device Sales & Marketing License: Only a Japanese company can obtain this license
  2. Foreign Medical Device Manufacture 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 will require an Importer of Record (IOR). Only the IOR can complete steps 2 and 3 on behalf of the foreign manufacturer.

It’s imported to note that your IOR will control your product marketing rights. Ensure that you choose an IOR that does not place restrictions on your Japan sales channels. COVUE does not restrict sales channels.  Distributors can act as your IOR. However, choosing distributor as your IOR can lead to problems if that distributor does not perform as expected.


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

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