CBER
The article outlines the Q-Submission process, detailing regulatory requirements, clarifications, and recommendations to help stakeholders ensure compliance.
RegDesk News/Info
In today’s medical device industry, innovation alone isn’t enough. To succeed globally, companies must also navigate a maze of regulations that vary across different markets.
Bosnia
Discover Bosnia and Herzegovina’s medical device information system with the new guide from the Agency for Medicines and Medical Devices.
China
The new article provides an overview of the revised guidance dedicated to registration of medical devices intended to be marketed and used in China.
Medical Devices
Manufacturers must navigate complex approval processes across different global markets. A central concept in many regulatory pathways is the use of predicate devices.
CMDE
The article describes in detail the approach to be followed by the parties involved in operations with digital medical devices in order to ensure the safety and proper performance of their products
