Medical Devices
Entering the global medical device market is a complex journey that requires a deep understanding of diverse regulatory landscapes. From the United States to Japan, each country has its own set of rules, timelines, and expectations.
Australia
The document provides an overview of the applicable regulatory requirements in the sphere of unique device identification.
Medical Devices
Jodi Granger is the Director of Regulatory Affairs at RegDesk.
Medical Devices
In the highly regulated medical device industry, quality and compliance are non-negotiable. ISO 13485, the international standard for Quality Management Systems (QMS) in the medical device industry, plays a critical role in ensuring that manufacturers meet regulatory requirements for medical devices and in-vitro diagnostic products.
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.
