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【South Korea 】Korea and Brazil Expand Regulatory Harmonization Cooperation in Cosmetics and Medical Products, Including GHC Program Participation

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Editor's note

This editor's note highlights a key sourcing signal: the Korea MFDS's GHC confirmed ANVISA's participation in September's GCORAS meeting. For buyers, this regulatory alignment reduces barriers for Korean cosmetics and medical devices entering Brazil, a critical growth market. The potential AREE listing and GMP mutual recognition could streamline approvals and lower compliance costs, making this a supply-chain risk worth monitoring.

South Korea and Brazil are deepening regulatory cooperation in cosmetics and medical products, following a February MOU that expanded the scope to include cosmetics. The Korea Ministry of Food and Drug Safety’s Global Regulatory Harmonization Center (GHC) confirmed Brazil’s ANVISA will attend the September Global Cosmetics Regulatory Authorities Meeting (GCORAS) in Seoul. This signals smoother market access for Korean aesthetic and cosmetic products in Latin America, a key growth region for medical aesthetics buyers.

Bilateral meeting outcomes

During the ICH and IPRP meetings in Brazil (June 2–4), GHC presented its activities and held a bilateral meeting with ANVISA’s director. Discussions focused on practical cooperation following the February MOU, which revised a 2014 agreement to include cosmetics alongside food, drugs, and medical devices.

Key cooperation areas

Topics included ANVISA’s participation in the September GCORAS in Seoul, GHC training programs, a proposal to list Korea’s MFDS as an Equivalent Foreign Regulatory Authority (AREE), and mutual recognition of medical device GMP inspection results. Currently, AREEs for approvals include 8 agencies like the FDA, while GMP relies on PIC/S members.

Regulatory and channel signals

Both agencies agreed to continue expanding cooperation to modernize regulatory systems and strengthen regulatory capacity, supporting smoother market entry for industries. ANVISA also confirmed interest in attending the ICMRA summit. The ICMRA is a coalition of 40 member countries and the WHO focused on strategic alignment among drug regulators.

What buyers should watch

For overseas importers and distributors, this regulatory alignment reduces barriers for Korean cosmetics and medical devices entering Brazil. The inclusion of cosmetics in the MOU and potential AREE listing could streamline approval processes. Buyers should monitor the September GCORAS outcomes and any updates on GMP mutual recognition, which may lower compliance costs for Korean-made aesthetic devices and skincare products in Latin America.

Source: Read the original report | Published: June 16, 2026