Transfer of Ownership of Registrations at ANVISA
Understanding the Transfer of Ownership of Registrations at ANVISA. The Resolution No 233/2018, began to allow the transfer of registration ownership of products subject to Health Surveillance through commercial operations.
Brazil’s Anvisa & Medical Device Single Audit Program (MDSAP)
Good Manufacturing Practices (GMPs) x Medical Device Single Audit Program (MDSAP)
Brazil’s Anvisa Medical Device Single Audit Program
GRP Blog explains the Registration process of Medical devices and IND in Brazil with The Brazilian Health Regulatory Agency (ANVISA). New issued regulation RDC No. 751/2022 on Sept. 21, 2022 have updated the registration process.
Brazil’s Anvisa update to Medical Device Regulation RDC 751/2022: The Importance of Grouping Devices
GRP Blog explains the Registration process of Medical devices and IND in Brazil with The Brazilian Health Regulatory Agency (ANVISA). New issued regulation RDC No. 751/2022 on Sept. 21, 2022 have updated the registration process.
Registration Process of Medical Devices and IVDs in Brazil
GRP Blog explains the Registration process of Medical devices and IND in Brazil with The Brazilian Health Regulatory Agency (ANVISA). New issued regulation RDC No. 751/2022 on Sept. 21, 2022 have updated the registration process.
Brazil’s Anvisa changes the Importation of Controlled Drugs Regulations
Brazil’s Anvisa changes the Importation of Controlled Drugs regulations. (2023)
Anvisa Establishes New Rules for Labeling Personal Care Products, cosmetics and perfumes.
The Brazilian Health Regulatory Agency (ANVISA) issued the regulation RDC No. 752/2022 Labeling rules for Cosmetics in Brazil.
Mexico’s Cofepris and U.S FDA agree on vision for the future with 2023 implementation plan.
On February 13, 2023, COFEPRIS released Communicate No. 15/2023, a press communicating, their strategic alliance with the US FDA in the 2023. The strategy discusses primarily, The guarantee of the safety, quality, and efficacy of medicines in Mexico and the United States. Secondly, That Both authorities work on food safety for the benefit of the health of the populations of both nations.
Brazil’s Anvisa Updates Medical Device Regulations with RDC 751/2022.
The Brazilian Health Regulatory Agency (ANVISA) issued the new medical device regulation RDC No. 751/2022 on Sept. 21, 2022.
Japan’s MHLW Publishes New Quality Standards for Quasi-Drugs
On October 2022, the Japanese Ministry of Health, Labour and Welfare (MHLW) has published new quality standards and specifications of 2,647 ingredients and additives that can used in Quasi-drugs.
Brazil’s Anvisa authorizes Remdesivir for Pediatric- Use in the treatment of Covid-19
Anvisa approved, on Monday (11/21), the extension of use of the antiviral drug Remdesivir for pediatric use in the treatment of Covid-19.
Brazil’s ANVISA Approves new Normative for the Registration of New and Innovative Medicines
On October 2022 Anvisa publishes approval measures for the registration of new and innovative medicines in Brazil