Exploring the Diversity of Medical Devices for Health Promotion in Brazil

Overview: Brazil stands out as the main market for medical devices in Latin America, with an established, albeit complex, regulatory system. Medical products in the country are regulated by the National Health Surveillance Agency (ANVISA). Against this backdrop, we explore the main types of medical devices and their specific applications within the Brazilian context. Introduction: […]

“Electronic Submission Now Available for Investigational New Drug Application (IND) Safety Reports”

The FDA has issued a reminder to drug sponsors and researchers regarding its recent publication of guidance outlining the process for electronically submitting investigational new drug application (IND) safety reports to the FDA Adverse Event Reporting System (FAERS). IND individual case safety reports (ICSRs) can now be submitted electronically through either the Electronic Submission Gateway in ICH E2B (R3) format or via the Safety Reporting Portal, with the FDA now accepting such submissions.

Health Product Labelling Requirements for Imported Products into Brazil

The import of Health products into Brazil is subject to various regulations, with proper labelling being a crucial part of this procedure. These regulations cover the current standards for labelling imported products, outlining the responsibilities of importers and the essential elements that must be included on labels.

US FDA Publication on Integrating Artificial Intelligence into Healthcare Product

On March 2024, the FDA released its latest publication titled “Collaborative Efforts: Harnessing Artificial Intelligence in Medical Products,” shedding light on the concerted actions undertaken by CBER, CDER, CDRH, and OCP in navigating the landscape of AI integration within the medical product realm. This comprehensive document delineates strategic focal points essential for advancing the application of AI throughout the entire lifecycle of medical products.

US FDA Extends Deadline for MoCRA Complaince

Understanding the Registration Process of Cosmetics with Anvisa

On November 8, 2023, the U.S. Food and Drug Administration (FDA) announced its intention to extend the enforcement deadline for cosmetic product facility registration and listing requirements as established by the Cosmetic Modernization Regulation Act of 2022 (MoCRA). The six-month extension is intended to provide industry with additional time to comply with the required facility registration procedures and provide detailed information on cosmetic products, thereby ensuring a smooth transition to the new regulations.