Japan Cosmetic Registration Service
Navigate complex local regulations with our expert guidance. From product registration to designated representation services.
Soluciones integrales
Regulatory solutions to ensure your cosmetic products are fully compliant and ready for the Japan market.
Expert guidance for general cosmetics notification and quasi-drug registration in compliance with MHLW and PMDA requirements.
Review formulations against Japan’s Cosmetic Standards and Quasi-Drug Ingredient Standards to ensure compliance.
Determine whether the product is a cosmetic or quasi-drug and interpret applicable Japanese regulations.
Provide support for quality systems, adverse event reporting, and product recall management.
Support preparation and submission of technical documentation, including safety, stability, and efficacy data (for quasi-drugs).
Ensure labels meet Japanese requirements and claims align with approved scope and advertising rules.
Por qué elegirnos
Navigate Japan’s high-barrier market with expert guidance and flexible compliance solutions.
Preguntas frecuentes
What is the first step before entering the Japanese market?
Determine whether the product is a cosmetic or quasi-drug, as the regulatory pathways differ significantly.
Who can act as the responsible entity in Japan?
A licensed Marketing Authorization Holder must be established under the supervision of the Ministry of Health, Labour and Welfare (MHLW).
Is notification required for cosmetics in Japan?
Yes. Both manufacturer notification (via PMDA) and product notification (to local authorities) must be completed before sale.
Do quasi-drugs require approval?
Yes. Quasi-drugs must obtain pre-market approval, which may include GMP inspection and technical review.
What are common compliance risks?
Key risks include incorrect classification, non-compliant ingredients, unsupported claims, and missing licenses or GMP compliance.