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Medical device market access in Ecuador is regulated by the National Agency for Regulation, Control and Health Surveillance (ARCSA). All medical devic…

1. Background The Association of Southeast Asian Nations (ASEAN) was established in 1967 and currently comprises 10 member states, including Indonesia…

Who Can Act as the Applicant for Medical Device Registration in Macau? Under Law No. 12/2025 – Regulation on the Supervision and Administration of Med…

In the process of medical device registration in Indonesia, product labeling may appear to be a minor detail. In practice, however, it is one of the c…

Key Compliance Considerations for Medical Device Registration in Kenya.

This article interprets the Manual for Registration of Health Products at ANVISA (Manual para Registro de Materiais de Uso em Saúde na ANVIS…

1. Regulatory Authority & Framework Cosmetics in Colombia are regulated by: Decreto 677 de 1995 Decreto 219 de 2022 Resolución 1482 de 2021 Andean…

1. Regulatory Authority & Framework Cosmetics in Mexico are regulated by: Ley General de Salud (General Health Law) Reglamento de Control Sanitari…

1. Regulatory Authority & Framework Cosmetics in Canada are regulated under: Food and Drugs Act Cosmetic Regulations (SOR/2007-195) Consumer Packa…

1. Regulatory Authority & Framework Unlike most countries (ASEAN, GCC, LATAM), Australia does NOT register cosmetic products with a health authori…

1. Regulatory Authority and Framework Cosmetics in the U.S. are regulated under: Federal Food, Drug, and Cosmetic Act (FD&C Act) MoCRA (Modernizat…

Brazil Cosmetic Registration (ANVISA – Agência Nacional de Vigilância Sanitária) 1. Regulatory Authority & Framework Cosmetics in Brazil are regul…