Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published detailed guidance dedicated to all the aspects related to the medical device establishment license (MDEL). Apart from the regulatory procedures to be followed by an...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the assessment of radiofrequency(RF)-induced heating in the magnetic...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices intended to be marketed and used in the EU, has published a joint implementation and preparedness plan for the In Vitro Diagnostic medical devices...
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the risk-based classification system for in vitro diagnostic devices (IVDDs). The document is intended to provide medical device...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a consultation paper describing proposed changes to the regulation of personalized medical devices. As mentioned in our previous article...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to cybersecurity aspects related to medical devices containing off-the-shelf (OTS) Software. Due to the...
