
FDA Draft Guidance on Electronic Submission Template for Q-Submissions
The article outlines the Q-Submission process, detailing regulatory requirements, clarifications, and recommendations to help stakeholders ensure compliance.
The article outlines the Q-Submission process, detailing regulatory requirements, clarifications, and recommendations to help stakeholders ensure compliance.
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.
Discover Bosnia and Herzegovina’s medical device information system with the new guide from the Agency for Medicines and Medical Devices.
The new article provides an overview of the revised guidance dedicated to registration of medical devices intended to be marketed and used in China.
Manufacturers must navigate complex approval processes across different global markets. A central concept in many regulatory pathways is the use of predicate devices.