In addition to non-regulated products, COVUE is licensed for Medical devices, Pharmaceuticals, Quasi-drugs, Supplements, Food, Food Apparatus, Alcohol, Industrial Salts and Fertilizers, Cosmetics & Personal Care and Electronics.
Our licenses extend far beyond importing and include, Manufacturing, Sales & Marketing, Marketing Authorization Holder (MAH), Repair & Installation, Product Recalls, Call Center Support, Tax Representation and Japan Register Invoice issuance.
No. If you wish to add more products after receiving approval, you will need to submit a new application to the PMDA (Pharmaceuticals and Medical Devices Agency).
We advise you to include all products in the first import application.
No. As part of the application process, it is required to send two samples of each parent product to COVUE. General lab testing is included with your application and covers 99% of all testing requirements.
On rare occasions, the PMDA can request for special testing of a product outside of the normal testing parameter. Please note that such special testing includes additional charges.
No. Japan law requires regulated products to be received at the location of registration for Incoming Quality Control (IQC) inspections. This includes compliance label verification and random lab testing.
There is no additional fee for lab testing. COVUE will only charge a fee for label application.
Your Shipping Invoice will reflect your online selling price. A Foreign Online Sellers Report (FOSR), which reflects your online sales pricing, will be included with your shipping invoice.
Japan Customs will verify your report against your actual account listings.
Example:
Your Shipping Invoice will reflect in coterms DDP.
SKU 1234
Unit Price: 1000 JPY
Qty: 10
Total: 10,000
Subtotal: 10,000
FOSR will reflect Online Sales Listing Pricing (must match your Shipping invoice)
COVUE will handle your inbound Japan logistics (JIL) = Port pick up, customs clearance, last mile delivery. COVUE will bill you for this service including the tax payment (1000).
Note: This is also the same if COVUE is handling the Door-to-Door shipping, pick up home country location, and JIL.
At customs clearance, COVUE will pay 1,000 JPY on behalf of your company to Japan Tax during customs clearance.
14 days after receiving clearance, an official receipt is issued for the tax payment by Japan Customs. This document is uploaded to your COVUE account in MY FILES.
For product pricing to your retailer, your Sales Invoice will specify “includes 10% Japan Consumption Tax (JCT)”
Example:
SKU 1234
Unit Price: 1000 JPY
Qty: 10
Total: 10,000
Subtotal: 10,000
JCT 10%: 1,000
Total: 10,100
Your distributor will transfer 10,100 to you for payment.
Your Shipping Invoice will reflect in coterms DDP.
SKU 1234
Unit Price: 1000 JPY
Qty: 10
Total: 10,000
Subtotal: 10,000
COVUE will handle your inbound Japan logistics (JIL) = Port pick up, customs clearance, last mile delivery. We will bill you for this service including the tax payment (1000).
Note: This is also the same if COVUE is handling the Door-to-Door shipping, pick up home country location, and JIL.
At customs clearance, COVUE will pay 1,000 JPY on behalf of your company to Japan Tax during customs clearance.
14 days after receiving clearance, an official receipt is issued for the tax payment by Japan Customs.
This document is uploaded to your COVUE account in MY FILES.
You can email a copy of this document to your distributor. They can use this document with their sales invoice to claim back the tax paid.
If you have a single distributor (or same distributor), and will be holding stock, the JCT will be paid at customs clearance based on the contract agreement or pricing agreement with your distributor.
If you have more than one distributor with multiple pricing models, COVUE will work with Japan Tax and Customs Clearance to establish an Average Transfer Price base on the actual distributor pricing agreements. This will be the official import declaration. The same receipts will be issued and the distributor will use this receipt and their Sales invoice to claim back the actual JCT Tax paid to you.
Due to unfortunate events and deaths from imported milk products, Japan has strict rules and regulations for milk and powdered milk as a food or ingredient. When using milk as an ingredient, Japan will seek additional information about your manufacturer including company name, source of milk, manufacturing flow process, etc.
Failure to provide the information will result in rejection of the product or application.
In this case, CBD will be subject to one or more applications/notifications. COVUE will only charge the application for the main product category such as Cosmetics or Food.
The CBD products will be regulated under the primary category in Japan.
Yes, there are some ways to avoid PSE requirements.
- Do not include the wall charger with the product. Include only a USB cable. This will avoid PSE requirements.
- If the LI battery is accessible to the user, change the design to make the LI battery not accessible.
- Sell and fulfill your orders under personal import from outside Japan. Note: This is only be available through the end of 2024 and may be subject to change without notice.
- Source your wall charger or LI battery within Japan.
Food apparatuses (or food contact materials) such as utensils, dishes, packaging, etc. must comply with the Food Sanitation Act (FSA), implemented by the Ministry of Health, Labor and Welfare (MHLW).
This includes compliance with regulations regarding material composition, the potential for toxic substance leaching, and more.
No. Stainless steel, glass porcelain and other similar materials usually do not require material testing.
However, MHLW reserves the right to require lab testing for any reason.
Yes. MHLW requires an application and approval for every shipment. COVUE is able to replicate applications for follow-up shipments on prior approved products. COVUE does not charge an application fee for application replication.
Yes, the new application fee is tied to the IOR and manufacturing plant.
COVUE provides product pre-checks prior to opening an import application.
Japan has strict rules for packaging claims. Example: You cannot claim a product prevents heart attack or anti aging. COVUE can assist with product claim localization to ensure your product is fully compliant.
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