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.
The U.S FDA Announces Pilot Program for Medical Device Submission with Health Canada


Overview On January 2023, the FDA announced that it has partnered with Health Canada to launch a joint eSTAR pilot. The pilot will allow medical device manufacturers to submit a premarket notice submission to FDA and Health Canada simultaneously. Introduction The eSTAR is an interactive PDF form that helps guide applicants through the medical device […]
China’s CMDE Drafts Guidelines for the Registration of Implantable Medical Devices


On January 2023, the CMDE issued Chinese regulators issue regulations for enterprises’ management of medical device safety, plus draft guidelines for the registration and review of implantable medical device batteries.
China’s NMPA issues more Technical Guidelines for Bioequivalence Studies


China’s NMPA issues four technical guidelines for bioequivalence studies of specific varieties