Discover That it is Possible to Import Dental Products.
Discover That it is Possible to Import Dental Products
“Discover the critical role that packaging plays in the development of cosmetic products.”
“Discover the critical role that packaging plays in the development of cosmetic products.”
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
Review of the Draft Technovigilance Standard by COFEPRIS in Mexico.
US FDA Publication on Integrating Artificial Intelligence into Healthcare Product Copy
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.
” 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
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
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: […]