ANVISA
The article provides a brief overview of the regulatory requirements applicable to personalised medical devices intended to be marketed and used in Brazil.
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.
Brazil
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...
Brazil
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...
Brazil
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...
