The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the use of market authorization evidence from comparable overseas regulators/assessment bodies for medical devices (including in vitro diagnostic ones) for abridgement of TGA conformity assessments and as information required for applications for inclusion in the Australian Register of Therapeutic Goods (ARTG).
The Therapeutic Goods Administration (TGA or the Agency), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the use of market authorization evidence from comparable...
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published final guidance dedicated to the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, a voluntary pathway simplify the approach to be...
The Medical Device Authority (MDA), the department of the Ministry of Health Malaysia responsible for medical device regulations, has published guidance dedicated to the registration of conformity assessment bodies (CABs). The document consists of two parts: general...
The European Commission (EC), the European body responsible for medical device regulation, published a summary dedicated to the availability and capacity of notified bodies to perform the conformity assessment of medical devices and in vitro diagnostic medical devices...