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.
The new article addresses aspects related to the regulatory requirements for the importation of medical device accessories, as well as combination products and refurbished medical devices. Table of Contents The Brazilian regulating authority in the sphere of...
The article provides an overview of the applicable regulatory requirements in the sphere of importation of medical devices the parties involved should comply with to be allowed to undertake such activities. Table of Contents The Brazilian regulating authority on...
The article provides an overview of the regulatory requirements for software as a medical device in Brazil. The Brazilian regulating authority in the sphere of medical devices (ANVISA), has published a questions and answers document dedicated to the regulatory...
The National Health Surveillance Agency (ANVISA) of Brazil has announced changes in the regulations on Class II medical devices. The devices are allowed to be placed on the market under simplified (notification) procedure providing that it is sufficient for the...
ANVISA
