The Therapeutic Goods Administration (TGA) of Australia has published detailed guidelines describing the most important aspects related to the Essential Principles. The publication is intended to provide medical device manufacturers, sponsors, and other parties...
The Food and Drug Administration (FDA) of the US has published an updated version of its guidance document dedicated to the coagulation systems for measurement of viscoelastic properties. The initial version of the guidance was published earlier on January 14, 2021....
The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s agency responsible for the assessment of quality and safety of medical devices, has published an official notice describing the updated rules on a temporary suspension of...
The Malaysian Medical Device Authority (MDA), Malaysia’s agency responsible for regulations in the sphere of healthcare products, has published draft guidance dedicated to the general medical device grouping. The document was published on the official website and made...
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published detailed guidance dedicated to personalized medical devices. The document provides additional clarifications and recommendations regarding...