Europe
The Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) issued guidance dedicated to the regulatory requirements of protective elements on colored drawings on medical device packages. In particular, the document describes specific aspects to be...
FDA
The Food and Drug Administration (FDA or the Agency) issued updated guidance on processes and standards for the inspections of medical device establishments. Inspections Regulatory Backgrounds The new approach to medical device establishment inspections is based on...
FDA
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical device regulation, announced amendments to the MDDT framework. Medical Device Development Tools (MDDT) The Agency published a notice dedicated to certain amendments made to...
Australia and Oceania
In relation to difficulties associated with the coronavirus, The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, issued a notice dedicated to the delay in the implementation of certain regulatory changes in...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, put out a statement to finalize the process of feedback and received comments from industry representatives regarding public consultations on the scope of...
