In September 2023, the US FDA issued regulatory updates, to the guidance on the Innovative Devices Program and preliminary guidance on medical devices associated with weight loss.
Registration holder for Medical Devices Imported from Mexico.
GRP Mexico can help you obtain COFEPRIS medical device registration and approval to sell your product on the Mexican market.
In August 2023, Mexican regulators have updated guidance on rules for modifications to medical device registrations that could streamline COFEPRIS reviews.
The import declaration is a fundamental step in importing goods into Brazil. Without it, customs clearance does not take place, and the goods transported do not reach the hands of the importer.
As of July, the new regulatory framework for drug labeling, the RDC 768/22, from the National Health Surveillance Agency (Anvisa), comes into effect.
In May 2023, the U.S. Food and Drug Administration issued five more final orders completing the process of publishing different monographs as part of the over the counter (OTC) monograph reform under the Act CARES.
Brazil’s Anvisa changes the Importation of Controlled Drugs regulations. (2023)
The Brazilian Health Regulatory Agency (ANVISA) issued the regulation RDC No. 752/2022 Labeling rules for Cosmetics in Brazil.
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.
The Brazilian Health Regulatory Agency (ANVISA) issued the new medical device regulation RDC No. 751/2022 on Sept. 21, 2022.
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 […]