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.
Brazil’s Anvisa Updates the Labeling of Cosmetic Products – 2024
The Labeling of Cosmetics in Brazil’s regulations will start including INCI requirements in 2024.
Brazil’s Anvisa’s Medical Devices for In Vitro Diagnosis Regulation (RDC 830/2023) comes into force in June 2024
Anvisa’s RDC 830/2023 Regulating Medical Devices for In Vitro Diagnosis comes into force in June 2024
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.
Ensuring the Thermal Integrity of Pharmaceutical Products in Brazil
Brazil’s Anvisa, legislation provides guidance on the qualification of the transportation of biological products in bulk in their primary and finished packaging.
Consultations Meetings with Anvisa – Health Products
Scheduling your Meeting Consultations with Anvisa: Brazilian System-Parlatory
US FDA Extends Deadline for MoCRA Complaince
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.
US FDA publishes Permanent Accreditation System Conformity Assessment Program
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
Registration holder for Medical Devices Imported from Mexico.
OTC Monograph Order Request (OMOR) Fee Rates for Fiscal Year 2024 Announced by FDA
OTC Monograph Order Request (OMOR) Fee Rates for Fiscal Year 2024 Announced by FDA