Importing Medical Devices

Importing medical devices into Japan requires PMDA approval.

If you are a foreign company without Japanese subsidiary, you are required to have a medical device licensed Japanese importer of record (IOR).

Process for importing Medical Devices
  1. Register with COVUE IOR
  2. Manufacture & Product Ingredient Pre-notification
  3. Sample Product Check
  4. Regulation Analysis
  5. Application of Foreign Factory & Shipper
  6. Product Import Application
  7. Document Work for Product Standards (Japanese)
  8. Prepare Japanese Labeling (regulated/certified)
  9. Receive Approval
    The process for takes an average of 16 weeks to receive approval.
    Once approved, the products may be imported under a general import license with COVUE.
    Japan laws require the products to be received into COVUE’s licensed facilities during which the following is required:
  10. Label verification for all products
  11. Trace & Track registration
  12. Sample Product Testing
    The process takes 24-48 hours. Once complete, the products may continue to the final destination.

Importing medical devices to Japan? Want to know if your products are subject to Medical Device Product Approval regulations?

Let COVUE handle it so you can focus on building your Japan business!

When selecting a licensed cosmetics partner, be sure to choose an IOR that does not place restrictions on your product rights Japan sales channels. COVUE is the preferred IOR choice for foreign cosmetics companies. We do not restrict product rights or sales channels. COVUE is the direct IOR: We own our licenses, compliance teams and, offer the online IOR platform. Take control of your Japan business and IOR with covueior.com

Let COVUE’s regulatory experts help you to speed up the market entry process so can that you can focus on your business. We’re here to help! It’s what we do best.

Process for Completing steps 2 and 3.
  1. Register with COVUE IOR
  2. Submit Product SKU
  3. Sample Product Check
  4. Regulation Analysis
  5. Application of Foreign Factory & Shipper
  6. Prepare Product Application
  7. Submit Product Application
  8. Document Work for Product Standards (Japanese)
  9. Prepare Japanese Label (regulated/certified)
  10. Prepare Shipping Documents
  11. Customs Clearance
  12. Receipt of Products in Licensed Warehouse
  13. Inspect 1 pc of each product SKU
  14. Product Document Control for MHLW
  15. Confirm Labeling & Packaging
  16. Delivery to Destination

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