Registration of RadioPharmaceuticals in Brazil
OVerview: ANVISA classifies radiopharmaceuticals in the following 3 categories: 1. Ready-to-use radiopharmaceuticals; 2. Non-radioactive components used with radioactive components; 3. Radionuclides, including eluates of radionuclide
Fast Track Registration of COVID-19 Vaccine in Brazil
OVerview: On 03/18/2020, Anvisa published a new regulation (RDC 348/2020), that defines the conditions of the priority review for the registration of covid-19 Vaccines .
Registration of Cosmetics in Brazil
Overview: The Brazilian beauty industry represents more than 2% of the country’s GDP. The Brazilian Cosmetic market is projected to overtake Japan as second place
Homologation of Medical Devices and their components in Brazil by ANATEL
OVerview: Medical Devices that use functionalities such as Bluetooth, Wi-Fi and other wireless connectivity features require ANATEL registration is required as part of the registration
China’s Green Channel- Priority Review Approval for Medical Devices
OVerview: In 2018 the NMPA launched an accelerated pathway for the examination and approval of innovative medical devices also known as Green Channel. Green Channel
Registration of Cosmetics in the USA
OVerview: Cosmetics marketed in the United States, whether manufactured domestically or imported must comply with the following regulations: Federal Food, Drug, and Cosmetic Act (FD&C
