USA Cosmetic Registration Service
Full support for the new MoCRA regulations and FDA cosmetic facility registration.
包括的なソリューション
Facility registration and product listing as required by the Modernization of Cosmetics Regulation Act.
Ensuring all packaging, artwork and product ingredient meets strict local regulation.
Assist with DUNS number application, FDA establishment registration, and NDC labeler code submission, ensuring sunscreen, anti-dandruff, acne treatment and other OTC products comply with FDA regulatory requirements.
Provide regulatory consultation and compliance assessment to ensure products meet target market requirements.
Includes annual updates of establishment registration and product listings to ensure ongoing regulatory compliance.
選ばれる理由
Navigate the U.S. cosmetic market confidently with expert compliance guidance and risk management.
よくある質問
What happens if information is inaccurate or incomplete?
Registration may be rejected or delayed, affecting timely market entry.
What if registration or listing deadlines are missed?
New establishments must register within 60 days of production; new products must be listed within 120 days. OTC products require establishment registration within 5 days of launch. Missing deadlines can impact compliance and sales.
How often do registration details need to be updated?
Cosmetic establishment registration must be updated every 2 years, and product listings annually. OTC establishment registration must be updated yearly, with product listings updated at least twice per year; otherwise, information becomes invalid.
Why is regulatory misunderstanding risky?
Misclassifying products (e.g., high-risk cosmetics or OTC products) can lead to applying incorrect regulations, affecting registration compliance.
What issues arise from non-compliant agents?
U.S. law requires foreign companies to appoint a U.S. agent. If agent information is inaccurate or the agent becomes unreachable, registration and product launch can be directly affected.