RegDesk Regulatory Roundup

Oct 26, 2021

TGA Guidance on Classification of Active Medical Devices: Basics

The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the classification of active medical devices (including software-based ones). The document issued in...

Oman Guidance on Fast Track High-Risk Medical Devices Registration

Oct 22, 2021

Asia

Oman Guidance on Fast Track High-Risk Medical Devices Registration

The Directorate General of Pharmaceutical Affairs and Drug Control, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements related to the registration of high-risk medical...