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Regulatory

The gateway to the whole one-stop program — getting your product into a legally sellable state in Japan.

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Sound familiar?

  • “Between the Pharmaceuticals and Medical Devices Act (PMD Act) and ingredient rules, we don't know where to start.”
  • “We aren't even sure whether our product counts as a cosmetic or a quasi-drug.”

How we solve it

We handle the whole path: category assessment, ingredient and label review, certification and notification, and securing an importer that holds a marketing authorization license.

Process

  1. 01

    Category assessment

    Classify the product as cosmetic, quasi-drug, food or general goods to fix the regulatory route.

  2. 02

    Ingredient and label review

    Check formulation limits, the full ingredient list and labeling against Japanese standards, and correct them.

  3. 03

    Certification and filing prep

    Prepare the cosmetics marketing notification or the quasi-drug approval dossier.

  4. 04

    Securing an importer

    Match and contract with a licensed marketing authorization holder to act as importer.

  5. 05

    Approval and ongoing compliance

    Manage amendments, renewals and risk monitoring once approval is granted.

Deliverables

  • Regulatory assessment report
  • Ingredient compliance report
  • Corrected labeling document
  • Approvals obtained

KPIs

  • Time to certification
  • Zero customs rejections
  • Zero recalls or administrative guidance

🇯🇵 Japan notes

  • PMD Act, Ministry of Health, Labour and Welfare, PMDA
  • Cosmetics = notification / quasi-drugs = approval (several months)
  • Strict ingredient disclosure requirements

Connected services

FAQ

Frequently asked questions

What approvals do I need to export Korean cosmetics to Japan?

Under Japan's PMD Act, a cosmetic requires a marketing notification, while a quasi-drug requires approval from the Ministry of Health, Labour and Welfare following a PMDA review. VIVID BRIDGE handles the full path: category assessment, ingredient review, preparing the notification or approval dossier, and matching you with an importer that holds a marketing authorization holder (MAH) license.

What is the difference between a cosmetic and a quasi-drug in Japan?

Cosmetics run on a notification basis and can be registered relatively quickly, while quasi-drugs — products claiming effects such as brightening or UV protection — need approval from the Ministry of Health, Labour and Welfare, which takes several months. Because the category follows the efficacy claims you make, reviewing ingredients and advertising copy up front is what keeps the route predictable.

How long does cosmetics licensing in Japan take?

A cosmetics marketing notification is generally complete within about two to four weeks once the paperwork is in order. Quasi-drug approval takes three to six months for the review itself, and six to twelve months in total once testing and responses to queries are counted. VIVID BRIDGE screens ingredient compliance in advance to avoid rejections and keep the schedule tight.

What documents are required to import cosmetics into Japan?

The core set is the marketing notification form, a full ingredient disclosure, the product standard document, manufacturing site information, and safety data. Quasi-drugs additionally require efficacy documentation and stability test data. VIVID BRIDGE supports the whole chain, from drafting the documents to securing an importer that holds the MAH license.

Regulatory — where to start?

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