Japan · Cosmetics

Japan Cosmetics Licensing and Notification

A practical guide to Japan Cosmetics Licensing and Notification for cosmetics sold in Japan: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it
Cosmetics manufactured or imported for sale in Japan; Brands, importers, and manufacturing licence holders
Authority
Pharmaceuticals and Medical Devices Agency (PMDA) and prefectures
Legal basis
Pharmaceuticals and Medical Devices Act
Local representative
A Japanese marketing authorisation holder is required
Timeline
Licensing takes time; product notification is required before sale
Cost
Licence and notification costs vary by product range
If you do not comply
Sales prohibition and enforcement action

Who needs this

Documents you need

Compliance checklist

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How to comply

  1. Obtain the appropriate business licence
  2. Notify each product to the prefecture
  3. Verify ingredient restrictions
  4. Label in Japanese according to the rules

Brief for your lab or agent

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Request: Japan Cosmetics Licensing and Notification — Japan
Product category: Cosmetics
Authority: Pharmaceuticals and Medical Devices Agency (PMDA) and prefectures
Legal basis: Pharmaceuticals and Medical Devices Act

Documents we already have:
  1. Manufacturing or import licence
  2. Product notification to the prefecture
  3. Ingredient and safety documentation
  4. Label with Japanese ingredient names

Questions:
  1. Does our product fall under Japan Cosmetics Licensing and Notification in Japan?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Licensing takes time; product notification is required before sale.

Licence and notification costs vary by product range.

Common rejection reasons

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.

Official sources

FAQ

Can a foreign brand sell directly?

No. A Japanese licence holder must be responsible for the product.

Are quasi-drugs treated the same?

No. Quasi-drugs have additional approval requirements.

How long does Japan Cosmetics Licensing and Notification take?

Licensing takes time; product notification is required before sale.

How much does Japan Cosmetics Licensing and Notification cost?

Licence and notification costs vary by product range.

What happens if I sell without it?

Sales prohibition and enforcement action.

Who regulates Japan Cosmetics Licensing and Notification in Japan?

Pharmaceuticals and Medical Devices Agency (PMDA) and prefectures.

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