New York, USA - October 15, 2025 - Proregulations today released its latest guide on market entry requirements for cosmetics in Japan and South Korea. The latest regulatory updates highlight the contrast between the two nations' market access frameworks. To address these variations, Proregulations offers specialized market entry solutions to assist companies in selecting the optimal strategy based on their product profiles.
The Japan cosmetics compliance system includes a strict two-tiered regulatory framework that distinguishes general cosmetics from Quasi-Drugs—a category encompassing products like sunscreens and whitening agents. All product categories must comply with the Japanese cosmetic standards for ingredients, and Quasi-Drugs are subject to an additional, rigorous pre-market approval process. For foreign manufacturers, a key challenge is obtaining accreditation from Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and the registration process requires 4 to 12 months to complete.
According to South Korea's cosmetics regulations, any company intending to import, distribute, or sell cosmetics must first complete the qualification registration as a Marketing Authorization Holder (MAH), which is the prerequisite for compliant market entry. On this basis, general cosmetics need to submit a product notification to the Korea Pharmaceutical Traders Association (KPTA) for market access, whereas functional cosmetics must obtain pre-approval from the Ministry of Food and Drug Safety (MFDS), the core of which is passing rigorous safety and efficacy evaluations.
"Currently, the requirements for importing cosmetics in both Japan and South Korea are well-established. As important cosmetic markets in the Asia-Pacific region and even globally, they hold significant market potential," said the head of Asia-Pacific at Proregulations. "Given the regulatory differences between the two markets, we recommend that companies develop detailed market entry strategies. This is particularly critical for specialized categories like Quasi-Drugs and functional cosmetics, which face higher compliance requirements, more complex registration procedures, and stricter reviews in Japan and South Korea."
Proregulations now offers specialized compliance solutions tailored to the distinct regulatory frameworks for the Japan and South Korea markets. These services cover key steps such as foreign manufacturer accreditation and Quasi-Drug registration for Japan, as well as general and functional cosmetics registration and post-market surveillance for South Korea. Proregulations's team provides expert support throughout the entire compliance process, from product registration and safety assessments to customized consulting solutions.
About Proregulations
Proregulations is a leading product safety and regulatory consulting company with a long-standing core mission of "Value in Compliance". From product registration and safety assessments to digital compliance navigation, their end-to-end assistance is complemented by strategic advisory services for financing and market entry. Establishing partnerships with local authorities in Europe, the US, and the UK, Proregulations has also strengthened its international capabilities. Its long-standing collaboration experience in other regions, such as the Asia Pacific, can also support clients' global expansion.
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Company Name: Proregulations
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Phone: 1-516-253-5040
Country: United States
Website: https://www.proregulations.com
