KSA
The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to companion diagnostic IVDs
Medical Devices
Packaging validation is a critical component of ensuring the safety, sterility, and integrity of medical devices.
EU
The new article provides clarifications regarding the transitional arrangements associated with the changes in the legal framework.
Medical Devices
Mastering regulatory change management is crucial for medical device companies to stay compliant and competitive in a rapidly evolving regulatory environment.
EU
The article describes in detail the approach to be followed in order to determine the regulatory status and applicable regulatory requirements.
