Australia
The article provides an overview of the regulatory requirements various sterility products are subject to in order to be allowed for marketing and use in Australia.
Swissmedic
The article outlines the key points related to Swissdamed, the country’s new information system for healthcare products.
BfArM
The article outlines the key points related to reporting serious adverse events in the context of clinical trials.
ANVISA
Globalization and the rapid advance of new technologies have presented a major challenge to regulators worldwide. Highly complex regulatory developments and the globalized production chain have advanced much faster than the availability of financial and human resources in most regulatory authorities.
Australia
The article provides an overview of the official notice describing the changes to the Australian regulatory framework for medical devices.
Swissmedic
The new article describes in detail certain specific aspects related to the incident reporting requirements introduced in Switzerland.
