Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published an official notice on conformity assessment bodies. According to the notice, starting July 1, 2021, entities based in Australia may apply...
EU MDR/IVDR
The Notified Body Operations Group (NBOG), an organization established by the European Commission to improve the performance of notified bodies earlier in 2000, has published a best practice guide dedicated to the designation and notification of conformity assessment...
EU MDR/IVDR
The Notified Body Operations Group (NBOG), an organization established by the European Commission to improve the performance of notified bodies earlier in 2000, has published a best practice guide dedicated to the designation and notification of conformity assessment...
FDA
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...
Asia
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...
