US FDA Regulatory Pathways for New Medical Devices
US FDA has stringent regulations for medical devices entering the US market. For launching a new medical device in US, you need to mandatorily comply with all FDA medical device regulatory guidelines. Additionally, you need to secure the applicable approval type for...
5 Common SFDA Medical Device Registration Challenges
Saudi Arabia is the gateway to accessing one of the fastest-growing medical device markets in the Middle East. Hence, entrepreneurs are aiming to reap the potential of the Saudi medical device market. Regulation of medical devices is a necessary requirement to ensure...
SFDA Medical Device Packaging, Assembly, And Sterilization Guide
Saudi Food and Drug Authority (SFDA), a government regulatory body, is responsible for ensuring safety and efficacy of medical devices. This regulatory body ensures the medical devices are at par with industry quality benchmark. The main goal of SFDA is to protect...