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Regulations & Import9 min readJune 24, 2026

Importing Korean Cosmetics to Japan: PMD Act & Market Guide

Importing Korean cosmetics into Japan in 2026 — the PMD Act, cosmetics vs quasi-drugs, the importer license, ingredient positive/negative lists, and Japanese labeling.

Japan is a sophisticated, high-value beauty market with deep consumer knowledge and, despite proximity, a regulatory system quite different from Korea's. It is one of the more complex destinations for Korean cosmetics — but also one of the most rewarding. Here is what to plan for.

The PMD Act and the importer license

Cosmetics in Japan are governed by the Pharmaceuticals and Medical Devices Act (PMD Act), overseen by the MHLW and PMDA. The defining feature for importers is that you cannot simply ship and sell: a licensed entity must stand behind the product.

To import and market cosmetics in Japan, the responsible party must hold a Cosmetics Marketing Authorization Holder license (and a separate import license). These licenses require a Japanese establishment and qualified personnel. In practice, most overseas brands partner with a licensed Japanese importer or distributor that holds these licenses and takes on the regulatory responsibility, rather than obtaining them directly. Selecting that partner is the central decision for Japan entry.

Cosmetics vs quasi-drugs — a critical split

Japan divides the category in two, and which side your product falls on changes everything:

  • Cosmetics (keshohin) — products with mild, general claims (cleanse, moisturize, beautify). These require notification, not approval, and can move relatively quickly.
  • Quasi-drugs (iyakubuhingai-hin) — products with active functional claims: medicated, whitening/brightening, anti-acne, anti-dandruff, and many sunscreens. These require pre-market approval of the product and its active ingredients, which is significantly slower and more demanding.

This mirrors, but is not identical to, Korea's functional cosmetics (quasi-drug) concept. The practical trap: a Korean product marketed on brightening or strong anti-aging claims may be pushed into the quasi-drug pathway in Japan. Decide early whether to pursue the quasi-drug route or to position the product as a standard cosmetic with softer claims.

Ingredient rules: positive and negative lists

Japan controls cosmetic ingredients through a mix of positive lists (permitted UV filters, preservatives, and colorants, sometimes with concentration caps) and prohibited/restricted lists. A formula that is perfectly compliant in Korea can include a preservative, UV filter, or colorant that is not permitted — or is capped at a lower level — in Japan. Every formula must be screened against Japanese ingredient rules before import, and reformulation is sometimes required. Your Korean manufacturer's full quantitative formula is essential for this check.

Japanese labeling

Labels must be in Japanese and follow PMD Act format requirements, including the marketing authorization holder's details, ingredient names per Japanese conventions, net content, and any required cautions. This is more prescriptive than English-market labeling, and it is handled together with your Japanese license-holding partner. Plan for Japanese-specific artwork, not a translation overlay.

Market notes

Japanese consumers are knowledgeable, ingredient-literate, and quality-demanding, with high expectations for texture, finish, and packaging. Korean brands have built a strong following, particularly in skincare — barrier care, hydration, PDRN and other advanced actives, and gentle daily-use products. Trust signals, careful claims, and refined packaging matter more than aggressive marketing. The market rewards consistency and quality over novelty alone.

What to confirm with your Korean manufacturer

  1. They can provide a full quantitative formula for Japanese ingredient screening.
  2. They understand the cosmetic vs quasi-drug distinction for your claims.
  3. ISO 22716 / GMP manufacturing with complete specification and test data.
  4. They can support the documentation your Japanese license-holding partner requires.

Planning a Japan launch? Submit an RFQ and we will match you with Korean manufacturers whose formulas and documentation are ready for the Japanese market.

This guide is general information, not legal advice. Japanese requirements change; confirm current PMD Act rules with your Japanese partner and a qualified consultant before importing.

Frequently Asked Questions

What license do I need to import cosmetics into Japan?

To import and sell cosmetics in Japan you (or your partner) must hold a Cosmetics Marketing Authorization Holder license under the PMD Act, plus an import business license. Most overseas brands work with a licensed Japanese importer or distributor that holds these licenses rather than obtaining them directly.

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

Japan splits the category into cosmetics (keshohin) and quasi-drugs (iyakubuhingai-hin). Products with active functional claims — medicated, whitening, anti-acne, and many sunscreens — are quasi-drugs requiring pre-market approval, which is slower and stricter than a standard cosmetic notification.

Can any Korean cosmetic ingredient be used in Japan?

Not automatically. Japan regulates ingredients through positive lists (for UV filters, preservatives, and colorants) and restrictions. A formula that is fine in Korea may contain an ingredient that is not permitted or is capped in Japan, so the formula must be checked against Japanese rules before import.

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OEMKorea Editorial Team

Korean beauty and supplement sourcing professionals