Market Authorization & Cosmetic Registration in Japan

Cosmetic Product Registration in Japan: Understanding the MAH Requirement

Cosmetic products in Japan are regulated by the Ministry of Health, Labour and Welfare (MHLW) under the Pharmaceutical and Medical Devices (PMD) Act. As Japan’s public health authority, the MHLW ensures strict compliance with regulatory standards, particularly around ingredients, labeling, and marketing claims.

Before cosmetic products can be marketed in Japan, manufacturers and importers must file a product notification. This process requires the appointment of a licensed Marketing Authorization Holder (MAH) — a critical step for market entry.

Why is a Marketing Authorization Holder (MAH) Required in Japan?

Foreign manufacturers cannot directly register or market cosmetics in Japan. Instead, they must appoint a local MAH — a licensed entity responsible for ensuring regulatory compliance throughout the product lifecycle.

Key Responsibilities of a Marketing Authorization Holder (MAH)

An MAH serves as your official regulatory liaison in Japan. Their core responsibilities include:

• Responding to remarks, requests, or communications from the MHLW and other authorities.

• Acting as the Point of Contact between the brand owner and the Japanese Health Authority.

• Collecting, investigating, and reporting adverse reactions or safety concerns.

• Advising on regulatory actions in the event of safety-related issues.

• Providing Japanese language support for submissions, labels, and communication.

• Ensuring full compliance of ingredients and labeling with Japanese regulations.

• Keeping you informed about regulatory changes impacting labels or documentation.

• Navigating appropriate regulatory pathways and documentation for classification (e.g., cosmetics vs quasi-drugs), in collaboration with authorities like the PMDA.

Key Challenges in Japan’s Cosmetic Registration

Navigating Japan’s cosmetic regulatory landscape can be complex. Common hurdles include:

• Misleading Claims: Unapproved claims related to product efficacy or safety may result in rejections or regulatory penalties.

• Quasi-Drug Classification: Products making functional claims (e.g., whitening, anti-dandruff, some sunscreens) may be classified as quasi-drugs. These require pre-market approval from MHLW and the PMDA, involving more rigorous review.

• Ingredient Listing Errors: Omissions or incorrect order in listing ingredients can cause delays or rejections.

• Labeling Compliance: All labels must be in Japanese, and poor translations often lead to non-compliance.

• Prohibited Claims: Terms such as “doctor recommended” or “clinically proven” are restricted unless specifically approved by the MHLW.

• Lack of MAH: Without a licensed MAH, foreign brands cannot submit notifications or manage safety reporting — making market access impossible.

How Freyr Can Help

At Freyr, we provide end-to-end regulatory support for cosmetic brands looking to enter the Japanese market. Our services include:

• Full MAH support, including local representation

• Product classification guidance (cosmetic vs quasi-drug)

• Regulatory submission preparation and communication with MHLW/PMDA

• Labeling and ingredient compliance checks

• Adverse event monitoring and reporting

• Ongoing compliance monitoring and regulatory intelligence

Ready to Launch Your Cosmetics in Japan?

With Japan’s regulatory environment becoming increasingly stringent, it’s essential to have a trusted partner to guide you. Freyr’s regulatory experts are here to ensure your products are fully compliant — from formulation and labeling to approval and post-market surveillance.

Contact Freyr today to ensure a smooth and successful product launch in Japan.