Mexico
This article details the process of modifying existing registration entries for medical devices permitted for marketing and use in Mexico. Table of Contents Mexico’s medical device regulatory authority, COFEPRIS, has released guidance on changes to the sanitary...
Asia
The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...
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...
FDA
The new article addresses aspects related to submission issue requests as a specific type of submission under the Q-Submission program. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
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...
