Homologation of Medical Devices and their components in Brazil by ANATEL
OVerview: Medical Devices that use functionalities such as Bluetooth, Wi-Fi and other wireless connectivity features require ANATEL registration is required as part of the registration
China’s Green Channel- Priority Review Approval for Medical Devices
OVerview: In 2018 the NMPA launched an accelerated pathway for the examination and approval of innovative medical devices also known as Green Channel. Green Channel
Registration of Cosmetics in the USA
OVerview: Cosmetics marketed in the United States, whether manufactured domestically or imported must comply with the following regulations:•Federal Food, Drug, and Cosmetic Act (FD&C Act),
How to Register a Hand-Sanitizer with the US FDA
Overview: The US FDA considers alcohol-based hand sanitizers as Over the Counter Products (OTC). The OTC are divided into two categories either health care antiseptics
Real World Evidence for Clinical Trials in China
Overview: On January 7th, 2020, NMPA published a new guideline on “Real-World Evidence that defines Real-World Data (RWD) and Real-World Evidence (RWE) terms and clarifies
Overview of Regulatory Requirements of Software as Medical Device (SaMD)
Overview: GRP’s whitepapers provides an overview of international guidelines for Software classified as a Medical Device. What is Software as a Medical Device? International Medical
