Turkey
The article provides a general overview of the current regulatory framework for the distribution and advertising of medical devices intended to be marketed and used in Turkey.
Saudi Arabia
The article provides a general overview of the classification framework for medical devices.
Malaysia
The article highlights the aspects related to the information to be included in the application an interested party should submit.
BfArM
The article highlights the aspects related to the life cycle of the digital health applications included in the respective directory.
FDA
The article highlights the aspects related to the first two methods of selecting predicates: for medical devices that are cleared based on well-established methods, and also for the products that meet or exceed the expectations.
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report
