Here is an overview of the requirements in India, Brazil, South Korea, and a few other notable markets:
India - Local Authorized Agent
Registration and Representation: Cosmetic products imported into India must be registered with the Central Drugs Standard Control Organization (CDSCO). A local authorised agent is required for this process.
Compliance Responsibilities: The local agent ensures compliance with the Drugs and Cosmetics Act, 1940, and the Cosmetics Rules, 2020, handling safety assessments, adverse event reporting, and more.
Brazil - Brazilian Responsible Person
ANVISA Registration: The Brazilian Health Regulatory Agency (ANVISA) requires cosmetics to be registered or notified before being marketed. A Brazilian Responsible Person is needed for this.
Local Compliance: The Responsible Person ensures that products comply with Brazilian regulations, including safety evaluations, labelling requirements, and GMP adherence.
South Korea - Korean Responsible Person
KFDA Compliance: The Ministry of Food and Drug Safety (MFDS) regulates cosmetics in South Korea. A Korean Responsible Person (KRP) is required to ensure compliance with KFDA standards.
Registration and Safety: The KRP handles product registration, safety assessments, labelling compliance, and adverse event reporting.
Japan - Japanese Designated Marketing Authorization Holder (DMAH)
PMDA Registration: The Pharmaceuticals and Medical Devices Agency (PMDA) requires foreign companies to have a Designated Marketing Authorization Holder (DMAH).
Local Duties: The DMAH is responsible for product registration, safety monitoring, labelling, and ensuring compliance with local regulations.
China - Chinese Responsible Agent
NMPA Registration: The National Medical Products Administration (NMPA) mandates that foreign cosmetics companies appoint a Responsible Agent in China.
Compliance Tasks: This agent oversees product registration, safety evaluations, adherence to labelling regulations, and manages post-market surveillance.
Australia - Australian Sponsor
NICNAS Registration: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) requires foreign cosmetics companies to appoint an Australian Sponsor.
Regulatory Duties: The sponsor ensures compliance with Australian regulations, including product notification, safety assessments, and labelling requirements.
Canada - Canadian Importer or Distributor
Health Canada Compliance: Cosmetic products must comply with the requirements of Health Canada. A Canadian importer or distributor acts as the local representative.
Local Compliance: They are responsible for product notifications, safety substantiation, labelling compliance, and adverse event reporting.
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