blogs Archives

” FDA determines that Medical Device Registrations must be submitted electronically from October 2025″

In August 2024, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced that starting in October 2025, medical device manufacturers must use the eSTAR (Electronic Submission Template and Resource) model for submitting new registration applications.

Clone Drug Registration with ANVISA: Understand the Process

Mexican Ministry of Health Advances with SaMD

The Mexican regulator, COFEPRIS, published the 5.0 edition of the Supplement for Medical Devices in the Mexican Pharmacopoeia, introducing regulatory requirements for Software as a Medical Device (SaMD).

Modifications to Container Closure Systems: Glass Vials and Stoppers

The FDA is providing this guidance to compile recommendations for the appropriate reporting categories and the content of post approval change submissions from various FDA guidance documents.

How Product Registration Hosting Can Boost Your Business Success

Brazil’s ANVISA Extends the Validity Period of the Brazilian GMP Certificate

ANVISA has extended the validity period of the Good Manufacturing Practices Certificate to four years.

Blog – Understanding the Registration Process of Cosmetics with Brazil’s Anvisa

Before starting the registration process in Brazil, it is essential that the company complies with all regulatory requirements. This involves obtaining the Operating License/Authorization from the local health surveillance agency and the AFE/AE from Anvisa.

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.